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Eupfi User Guide

1. Study Types provides the nature of investigations like randomized controlled cohort case studies etc Depending on the Study Type selected the results page data appears Advanced Search Page 36 Clinical Data Search For Excipents Study Types Age Category Route of Exposure Administration Function 6 1 1 2 Age Category Eu US PFI User Guide Acute exp Acute toxicity Chronic toxicit Dermal toxicity Select Adolescent Adolescents adults Adult Adults Oral intranasal intraocular occular oral Select Adsorbent Antimicrobial preservative Coating agent Confectionery base Age Category indicates is classified as per ICH classification CPMP ICH 2711 99 Based on the age category the relevant group name in indicated here a few group names are v Adolescents 12 to 16 18 years dependent on the region y Adults v Children 2 to 11 years v Infants Y Pre school Children vV School Children v Unspecified Advanced Search Page 37 Eu US PFI User Guide All the above appears in the Age Category drop down based on the selected Age Category corresponding excipients and the data appears in the search results page _ Clinical Data Search For Excipients Acute exposure Study Types Acute toxicity Chronic toxicit Dermal toxicity Adolescent Adolescents Age Category Cutaneous Route of Exposure Administration Dermal Closed pat
2. Basic Search Page 33 Eu US PFI User Guide 6 ADVANCED SEARCH Advanced Search supports user in selecting the search criteria in an easy manner User can access the Advanced Search page either from the Advanced Search link in the main menu bar or from the Advanced Search link in the Basic Search page at the bottom as shown below Search by Excipient Evciplent Name l Please anter minimum of 3 s Gaja T characters to populate Aspartame suggestions Benzalkonium chloride Benzoic acid Benzyl alcohol Please use Ctl Mouse click to select multiple values Please use icon to opan selection dialog box CAS Registry Number Balact Progressive search will be based een a and filtered on the values already aia El selected in dropdowns 1315 77 3 16731 55 Synonyms 45 per the Handbook of Excipients s Salag vinyl 2 pyrrolidinone polymer 1 2 Benzenedicarbowylic acid dimethyl ester 1 2 Diethyl phthalate L 2 propanediol Function n Galed Adsorbent Antimicrobial preservative Coating agent Confectionery base On clicking Advanced Search link either from main menu bar or from the basic search page the below Advanced Search page appears Advanced Search Page 34 Eu US PFI User Guide Clinical Data Search For Excaments Select A lRCLRe exposure Stud Tipes Acute toxicity Chronic imar Derm
3. a e O Papii ths 20 46 MaL 7 4 4 Species Species indicates the animal species used in the experiment Example rabbit rat sheep cat cattle dog gerbil guinea pig hamster monkey mouse pig and other as shown below Search Results Page 79 Eu US PFI User Guide Show Hide Imro Comes 7 ic e z E le we Faciphent Hee Stuck Tree Soe wri oa lini Route Cf Epon Or Administration Guration Of Treatesent uration Uniti SpE 7 4 5 Dose Dose s or concentration s tested administered including unit e g 0 112 220 523 mg kg bw day m f or 0 112 220 523 mg kg bw day m will be displayed based on the searched criteria as shown below Oa Mice Inaba Cabary E Bef Ei Ekg E E Shue sina rll Sean ll i Dires Umka aie LH Ea EE EE E i Aer rat h Durat mit repine hyh int Si ena maven Abocho caiaisay Baye Benzi Ainge 6 PRarmecongy Benzyl dhol Fhaemaccdogr Rebbi 7 4 6 Dose Units Dose Units represents the relevant dose unit terms of the dose based on the selected search criteria as shown below Show hide pmhatro Columns 4 Rel ID e Baa ns a i z A Eht Type Speeches Dare Dee Uri Reute OF Expcners Oy Adenintiaretion Dhrain Cf Trewin oration Unit Aen Ses QS ae EE EEE DEP T i O g aj Pharmacy Beri 145 5 HF a a Fearne ikoa Fhe maceedy re a Hr rane Lea at Banri Akoh Phy matoi aabt de
4. hon Clinical Data iiis Non Clinical Columns Ethanol Pharmacology lic ult Unspecified Unspecified 250 500 1000 Ethanol Pharmacology i Unspecified Unspecified 0 100 200 Pharmacology IC Unspecified Unspecified Ethanal Pharmacology hl Unspecified Unspecified Ethanol Pharmacology ul Un pecified Unspecified 50 100 Search Results Page 69 7 3 6 Age Eu US PFI Age column provides the numerical entry of the age Non Clinical Data Show Hide Non Clinical Columns Ref iD Excipient Name Study Type 38 Ethanol Neurotoxicity Ethanol Tolerance Ethanol Tolerance Ethanol Chronic Tomety Ethanal Developmental Ht 7 3 7 Age Units User Guide Unspecified Unspecified Juvenille Juvenile Juvenille Unspecified Unspecified 0 75 1 0 Displays the unit for Age provides in years months etc as shown below Non Clinical Data Show Hide Non Clinical Columns E Ref ID Ethanol Neurotoxicity Ethanol Tolerance Ethanal Tolerance Ethanal Chronic Toxicity Developmental Search Results Unspecified Unspecified Juverilla Juvenille Juvenille Unspecified Weeks 2000 4000 Page 70 Eu US PFI User Guide 7 3 8 Gender Displays the gender based on the search criteria in the relevant column as shown below Non Clinical Data Show Hide Non Clinical Columns eee i Excipient Name ay Type fiai Unspecified Unepaciiad Unspecified Ethanol Tolerance dice
5. b Le eee eee cee Function Antimicrobial preservative Coating agent Confectionery base s at Advanced Search Then the Search Results page appears displaying the corresponding information as shown below Search Results Page 49 Eu US PFI User Guide Search Results Total References 25 pened information Exciypent Chem ID Excipient Chemical tame Benzyl alcohol CAS Registry Number 100 515 Enopient CalegonF undian Phamacopoeial Status Regulatory Status Smonymns Aoceptable Daily Intake Revision Date be Data how Hide Clinical Columns eigen Mane Study ioe Age Category fe Age Units E Benzyl Alcohal Toxicokinetics fart 1 Year Benzyl Alechal Tomooimencs Linspeched Un pectied Unepecihed Unsp cised Benzyl Aleohal Acute Tonmcrty agslescentChadean 5 13 Acute Toscty Search Results provides the result information in a categorical manner for that the information is categorized into the below data v General Information v Clinical Data v Non Clinical Data v Invitro Data v Regulatory Reference v Reviews Search Results Page 50 Eu US PFI User Guide Among those General Information and Clinical Data information appears by default as shown below search Results Excipient Chemical Name CAS Registry Number Excipient Categary Function E Pharmacopoelal Status Regulatory Status
6. 1 2 propanedial Function Select Adsorbent jAancimicrobial preservative Coating agent Confectionery base Then click Submit button then below page appears Search Results Page 87 Eu US PFI User Guide Excipient s Intermediate Page Number of Excipient found 2 C An a Benzalkenium chloride E Benzyl alcohol In the above page user is allowed to select one or more than one excipient name using check boxes as shown below Excipient s Intermediate Page Number of Excipient found 2 Click Submit to retrieve the results Then the Search Results page appears as shown below Search Results Total References 34 Record 1of2 Excipient Navigation penera Information E m LE Go aFirst lt Prevous gt Next bLasi Exciment Chemical Name Benzalkonium chloride CAS Registry Number 8001 54 5 E Exciplent Category Function E Phanmacopoeial Status E Regulatory Status it Synonyms E Acceptable Daily Intake E Revision Date Clinical Data Show Hide Clinical Columns E Excipient Name Study Type Age Category Age Units Gender Route Of Exposure Or Administration p Senzalkorium Chronic Toxicity Adults an rs i Intraocular Chloride Benzalkonium Long Term Adults Unspecified Unspecified Intranasal Chloride Search Results Page 88 Eu US PFI User Guide In the search results page user can customize the columns by using the drop down option in all the column
7. CHi Ca Re Gervernen PL Moos Aapateme Sr Gresler Than 10 TL Hga Liga Dady Dossa 20 Tehet Ti Pore Page 63 a more link the complete information about the Dosage Form appears in an Beta a 1 roe Reference Typo Eu US PFI User Guide Mouse hover on more link also displays the complete information of the Dosage Form in a tool tip as shown below i Poo LU Shosi Hade Chinecal Cohan Duration Ulevits Firg H Administration fem Urean taiete f Tolerability Aer Efed Doge Form Concho Comments ielerence Rate rene Tveri O s n E Cemer P Megi Veeg on L ype eehymloge Mewccerchele Ho bed On Cogntnes Ard Bah Ma Effect al LES aT ay Cpe bee Meee Mere Cage ive A are Than 10 Ti More T Teras Day euro elope Aeuncpaycholo hbo eat Lispe inag ced Diot Auda Himerei Of he Bies O Sipa birr me nipami Losensg Lu More Unigeohed Haucdigs Sohier Gaia SLA tab he Bereta lene Sharylerarg Con Evideron Of Tex H Hanra E Ar 7 2 17 Conclusion Comments Comments indicate the overall remarks of the references Any remarks or concluding statement could be entered in this section It will be a free text editor field for creating formatted text and tables or inserting any excerpt from a reference Show Mede Clinkal Codumins E ent Duration Units Frega OF Amini ba Aban La Safety Tolerability Adwerme Eeri baa Form Celie Comme Betas Relercnne Tyr ALE pgh cere
8. GOST ia Developedby GVKYBIO AN G BIOM Then this Feedback Form page gets skipped and Basic Search Page appears as shown below Search by Excipient Excipient Name l Please enter minimum of 3 characters to populate suggestions shaun chloride Please use Ctrl a click to Benzyl alcohol ki select multiple values Please use Boy to open lection dia CAS Registry Number se log box Progressive search will be based and filtered on the values already selected in dropdowns Synonyms AS per the Handbook of Excipients oe 1 vinyl 2 pyrrolidinone polymer 1 2 Benzenedicarboxylic acid dimethyl ester 1 2 Diethyl phthalate 1 2 propanedial Getting started Page 16 Eu US PFI User Guide Note gt When user skips the Feedback Form and continues the work and logged out of the application and login to the application again then again this Feedback Form page appears gt Until unless user fills the Feedback Form this Feedback Form will appear for every login gt It s recommendable to fill the Feedback Form to avoid the above circumstances 2 6 Website links In the STEP application user can access the related websites using the icons in the page throughout the application When user clicks required logo then the corresponding website appears as shown below Welcome to EuPFI Microsoft Internet Explorer provided by GYK BIOSCIENCES la DIX why z 1 j h
9. If user selects Basic Search Page 28 Eu US PFI User Guide any other value in addition to the initially selected one then considering both those values remaining data appears 5 1 2 CAS Registry Number CAS Registry Number is a numeric designation assigned by the Chemical Abstracts Service of the American Chemical Society that uniquely identifies a specific chemical compound regardless of the name or nomenclature system used Example 57 55 6 for propylene glycol only a single excipient may be associated with a single CAS registry number The privilege of selecting the required CAS numbers using the CAS Registry number is also facilitated When user selects CAS registry number using CAS Registry Number then based on that selected CAS Registry Number remaining data in the Excipient Name Synonyms appears as shown below Basic Search before selecting the CAS Registry Number Search by Excipient Exciplent Name t Please enter minimum of 3 characters to populate suggestions Select Aspartame Benzalkonium chloride i Benzoie acid TRS Benzyl alcohol Please use Eiri House click to select multiple values Please use icon to open selection dialog box GAs Regisity Number Progreagsive search wili be based and filtered on the values already selected in dropdowns Synonyms 48 per the Handbook of Excipiants Selec bi vinyl 2 pyrrolidinone polymer 1 2 Benzenedicarboxylic acd
10. Re Excipient Name Study Type Reference Type Benzalkonium Chloride Cytotoxicity Benzalkonium Chloride Corneal Toxicity Benzalkonium Chloride Corneal Toxicity Heresies Chloride Cytotoxicity Benzalkonium Chloride Cytotoxicity Benzalkonium Chloride Genotoxicity Benzalkonium Chloride Genotoxicity Benzalkonium Chloride Gre Benzalkonium Chloride Immunotoxicity Search Results Page 92 Eu US PFI User Guide 7 9 Navigations in Search Results page Whenever user selects more than one excipient as shown below Excipient s Intermediate Page Number of Excipient found 2 Then clicks Submit button search results page appears displaying the corresponding information along with the navigation links to navigate in between the excipient selected as shown below Search Results Total References 34 Record 1 of2 Excipient Navigation General information Exciplent Chem ID Excipient Chemical Name Benzalkonium chloride CAS Registry Number 8001 54 5 fWFirst lt Previous Next Last H Excipient CategoryFunction Pharmacopoeial Status E Regulatory Status E Synonyms E Acceptable Daily Intake E Revision Date Show Hide Invitro Columns 4 Dose Units Route Of Exposure Or Administration Duration Of TES penzalkonium Cytotoxicity 0 00005 0 0001 0 0005 i Incubation Chloride La lorel Benzalkonum Cytotoxicity 0 00005 0 0001 0 0005 000 Incubation When user selects multiple excipients then o
11. dimethyl ester i 2 Diethyl phthalate 1 2 propanedial Function Select Adsorbent Antimicrobial preservative Coating agent Confectionery base Basic Search Page 29 Eu US PFI User Guide Basic Search after selecting the CAS Registry Number search by Excipient Excipient Name CAS Registry Number Synonyms fAs per the Handbook of Excipients Function Benzyl alcohol jalcha hydroxytoluene benzylic alcohol hydroxymeithylbenzene phenmethylal phenylearbinal Select Adsorbent Aniimierobial preservative Coating agant Confectionery base Mease enter minimum of 3 characters to populate suggestions Please use Ctrl House click to saiect multiple values Please use icon to open selection dialog box Progressive search will be based and filtered on the values already selected in dropdown Note Although user selects required CAS Registry Number value after selecting the Excipient Name but the data in the search results appears considering not only with the selected CAS Registry Number but also with all the other CAS Registry Numbers that are related to the selected Excipient Name Search by Excipient Exciplent Name CAS Registry Number Synonyms 48 per the Handbook of Excipients Function Basic Search alpha hydroxytoluene benzylic aleahol hydroxymethylbenzene phenmethyial Select Adsorbent Antimicrobial preservative
12. t A A g icipienti s lnitermediate Pare Number of Exciprent kund C as Cpen pi gnim iNi DiBentoe acd ub Doren loeb in ove ea User can select more than one excipient using the check boxes and click Submit button as shown below Number of Excipient found 2 Then the Search Results page appears displaying the relevant excipient data as shown below Advanced Search Page 41 Eu US PFI User Guide Total References 34 Record 1 of2 Excipient Navigation General Information Exciplent Chem I0 im 60 ai lt Previous gt Next PLast Excipient Chemical Name Benzalkonium chloride CAS Registry Number 8001 54 l Excipient CategorFunction el Pharmacopoeial Status E Regulatory Status E Synonyms E Acceptable Daily Intake el Revision Date Clinical Data Show Hide Clinical Columns l i Eid Name Study Type Me Category Route Of Exposure Or Administration De ag Banzalkonium Acute Exposure Unspecified Unspecified Unspecified Unspecified Intranasal Chloride User can navigate in between the excipients to view the resultant data using lt First lt Previous gt Next gt Last navigation links 6 2 Non Clinical Data STEP application provides the data of the excipients based on the various aspects one among them is the Non Clinical Data This provides complete optional environment depending on the Non Clinical Data attributes Below are the Non Clinical Data at
13. 06 25 2012 The benefits of becoming a Registered User with Step Database include access to the Reference Database collaboration in User Communities Best Practice and Tutornals This allows you to build your expertise in areas of particular interest to you and to create a myODSA Profile which is perzonalized for you EUPFI DATABASE END USER LICENSE AGREEMENT This End User license Agreement shall be governed by the United Kingdom laws without giving effect to princples of Al conflict of laws You hereby consent to the exclusive jurisdiction and venue of the courts sitting in London United Kingdom to resolve any disputes aring under this End User License Agreement F Ths End User license Agreement contains the complete agreement between the partes with respect to Me subject matter hereof and supersedes all pror or contemporaneous egreements or understandings whether oral or written You agree that eny varying or additional terms contained in any purchase order or other written notification or decument issued by you in relatan to The ONLINE STEP OATASASE licensed hereunder shall be of no effect The failure or delay of EuPFl to exercise any of its nights under this End User License Agreement or upon any breach of this End we go Me read the Disclaimer and accepted the Terms amp Conditions User Harme Organization Email Address Confirm Email Address Contact Py r Lounin Number j When user clicks Why Registr
14. Coating agent Confectionery base Please enter minimur of 3 characters to populate suggestions Ploase use Ctrl Mouse click to select multiple values Please usa icon to open selection dialog box Progressive search will be based and filtered on the values already selected in dropdowns Page 30 Eu US PFI User Guide Example In the above scenario user selected Excipient Names as Benzyl alcohol and CAS Registry Number as 100 51 6 and clicks submit Search Results page displays the results that are related to Benzyl alcohol along with CAS Registry Number 100 5 1 6 as shown below Search Results Total References 25 Record 4 of4 Excipient Navigation Excipient Chemical Name CAS Registry Number Excipiant Category Function Phannacopoeial Status Regulatory Status i Synonyms E Acceptable Daily Intake E Revision Date iShow Hide Clinical Columns Ref ID Excaient Name Study Type Age Category Age Units Benzyl Alcohol Taxicokinetics enzyl Alcohol Toxicokinatics Unspecified Unspecified Unspecified Unspecified 5 1 3 Synonyms Synonyms includes other chemical names trade names common or general names foreign language names with the language in parentheses or codes Only the key synonyms would be displayed and for details it would be linked to other source Example Chem ID Plus The privilege of selecting the required synonyms using the Synony
15. Download Do you want to open or save this file Name Eupri xportResults xls mm Type Microsoft Office Excel 97 2003 Worksheet From inFwrovo While files from the Internet can be useful some files can potentially harm your computer IF you do not trust the source do not open or save this file What s the isk Then the excel file appears with the selected data and based on the categorization data in the excel sheets will appear in separate sheets as shown below Fante BE A ee aa Merge Cenere a onna romat Len eent Delete Format gt O FING a J Format Painter 1 TSA thie Formatting as Table Styles REN Fiter Select Clipboard F Font i Alignment p Humbe la Styles Celt Editing Al l fi Excipient Names E General Information Ginical Data Non Cinical Data Invitro Data equistory References p Ready Scroll tock First page Search Inputs provides the information about the search criteria given by the user Export Page 100 Eu US PFI User Guide 8 2 Export to PDF When user clicks Export to PDF button as shown below Then the File download window appears as shown below Export Page 101 Eu US PFI User Guide File Download Do you want to open or save this file Name EupriExportRhesults pdr Type Adobe Acrobat Document From infora Caneel While fil
16. Heferer Tyee f E wu Eriti aoe Ho Eiet Dai Hot Jee Gi al Perera Ne Effet Of Lipase Astany Ne teeniicant Lipase Denese En Lip Lahare Isolated Heart No Effect aspartame Waa iachwe in ien L Horg Tha Areri Cosguleiign Time 7 4 14 References A reference indicates the source from which the information is extracted The references would be linked to their original source through DOI When possible the references would be linked to their original source through DOI The users who need the details of the study will be able to access the abstract or full text depending upon their subscription copyrights limitations Search Results Page 84 Eu US PFI User Guide 7 4 15 Reference Type Reference Type Indicator specifies the type of reference e g Study report or Publication Choices include study report company data publication review article or handbook other 7 5 Regulatory Reference Regulatory Reference includes the references to the regulations and regulatory requirements for a specific substance 7 5 1 References References indicate the source from which the information is extracted Bibliographic source of the study report or publication will be provided The references would be linked to their original source through DOI The users who need the details of the study will be able to access the full text if available with their subscription or will be able to access the abs
17. Login link as shown below Logout Page 19 Eu US PFI User Guide E PF dvr database Eiane Phacatc peagi iE Database of safety and toxicity of excipients for paediatrics You re logged out of Euphi Click here tol Loain es Developed GVK BIO GOSTAR GOBIOM wi Graia a Tian Then the login page appears as shown below I m an Existing Eupfi User Fong Login Erraal New User Register Now Why Registration Revision Date 06 25 2012 EVUPFI DATABASE END USER LICENSE AGREEMENT This End User License Agreement shall be governed by the United Fangdom Laws without giving effect to pnnciples of conflict of laws Tou hereby consent to the exclusive jureediction and venues of the courts sitting in London United Kingderm te resolve any disoutes arising under this End User License Agreement This End User License Agreement contains the complete agreement between the partes with respect to the subject matter hereof and supersedes all prior or contemporsn ous agreements or understandings whether oral or written You gree that any varying or additions terms contained in any purchase order or other written notification or document issued by you imn relation to Tre ONLINE STEP OATAS4SS5E licensed hereunder shall be of mo effect The failure or delay of EvPrl to exercise any of its nghts under this End User License Agreement or upon any breach of thes End O Ive read the Disclaimer and accepted the Term
18. Non Clinical Regulatory Reference Invitro Regulatory References and Reviews are different the customization selection applicable to that particular tab only if user selects any other tab among Clinical Non Clinical Invitro Regulatory Reference and Reviews then the complete data appears irrespective of selected customized value from the drop down as shown below Non Clinical Data how Hide Non Clinical Columns Benzalkanium i lat Toxicity Unspecitied Unspecified Unspecified 0 01 Oi Chiorida Senzalkonium Neurctomerty Rat Juvenille 2 3 Months Chiende Senzalkonium mmunatexicity iat Juvenille 3 Months Chloride 7 8 Show Hide Columns User is also allowed to view or to hide the required columns using the Show Hide Columns as shown below Search Results Page 90 Eu US PFI User Guide l imito Data Show Hide Invitro Columns l LE ID Excipient Name Study Te Type Dose Units Route Of Exposure Or Administration Duration OFT Of j m a m a a a e a Benzalkonium Cytotoxicity Human 0 00005 0 0001 0 0005 0 00 Incubation Chionde More Benzalkorium Corneal Toxicity Human 240 1 i Incubation Chloride Benzalkonium Corneal Toxicity Human 0 02 0 01 i Incubation Chloride When user clicks besides Show Hide Columns then it displays all the columns in the page as shown below By default all the columns appears in the checked state fshow Hide Invitro Colum
19. Search by Excipient Excipient Name CAS Registry Number Synonyms As per the Handbook of Excipients Function Search Results page appears considering the search criteria as shown below Search Results Excipient Chemical Name CAS Registry Number Excipient Categon Function Pharmacopoeial Status E Regulatory Status Synonyms Acceptable Daily intake Revision Date Clinical Data how Hide Clinical Columns E Eu US PFI Benzyl alcohol J Select Aspartame Benzalkonium chionde Benzoic acid Benzyl alcohol Select 100 51 6 131 11 3 1319 77 93 16731 55 8 nm Select 1 vinyl 2 pyrrolidinone polymer 1 2 Benzenedicarboxylic acid dimethyl ester 1 2 Diethyl phthalate 1 2 propanedial Antimicrobial preservative Coating agent Total References 25 Benzyl alcohol 100 51 6 User Guide Please enter minimum of 3 characters to populate suggestions Please use Ctrl Mouse click to select multiple values Please use 4 icon to open selection dialog box Progressive search will be based and filtered on the values already selected in drapdowns Record 10741 Excipient Navigation Study Type Age Category iga Age Units Gendei Ref ID Excipient Hame Benzyl Alcohol Towicokinetics Infant Benzyl Alechal Toxicokinetics Unspecified Unspecified Unspecified Unspecified Benzyl Alcohol Acute Toxicity Adalescent Chitdrem 5 13
20. Shown below Clinical Dats show hide Clinical Columns E E Benzyl Alcohol Benzyl Alcohol Benzyl Alcohol Benzyl Alcohol Search Results Toxicokinetics Toxicokinatics Acute Toxicity Acute Toxicity Infant Unspecified Unspecified Unspecified Unspecified Adolescent Children Page 55 Eu US PFI User Guide 7 2 3 Study Type Study Type provides the nature of investigations like randomized controlled cohort case studies etc in this field considering the search criteria given the relevant Study Type appears in the column types as shown below Clinical Dala Show Hide Clinical Columns E Excipient Hame Age Category se Age Units Route Of Exposure Or Administration 1 F Oral Year 34 Benzyl Alcohol Toxicokinetics Benzyl Alcohol Toxicokinetics Unspecified Unspecified Unspecified Unspecified Benzyl Aleshal Acute Toxicity Adolescent Children Benzyl Alcohol Acute Toxicity 7 2 4 Age Category Age Category indicates is classified as per ICH classification CPMP ICH 2711 99 Based on the age category the relevant group name in indicated Depending upon the search criteria the corresponding age category information will appear under Age Category column Clinical Data Show Hide Clinical Columns Excipient Name Study Type Age Category Benzyl Alcohol Toxicokineties Benzyl Alcohol Toxicokinetics Unspecified Unspecified Unspecified Unspecified Oral Benzyl Alcohel Acute
21. Synonyms E Acceptable Daily Intake Clinical Data how Hide Clinical Columns Benzyl alcohol Benzyl Alcohol Benzyl Alcohol 7 1 Total References 25 Benzyl alcohol 100 5 1 6 Shady Type Toxicokinetics Taxicekinetics Unspecified Linspecitied Acute Toxicity Adolescent Children 5 13 General Information Unspecified Gender Lrspecihed Record 1 off Excipient Mavigatio Route OF Exposure Or Administration Dg OOo Oral In the Search Results page considering the search criteria General Information provides the information about the corresponding Excipient along with the CAS Registry Number as shown below Search Results Excipient Chemical Name CAS Registry Number Excipient CategorFunction Phamacoposial Status Regulatory Status Synonyms Acceptable Dally Intake Revision Dale Search Results Total References 25 Benzyl alcohol 100 515 Record 1 of Excipient Navigatio Page 51 Eu US PFI User Guide In the General Information along with Excipient Chemical Name and CAS Registry Number few more details like Excipient Category Function Pharmacopoeial Status Regulatory Status Synonyms Acceptable Daily intake Revision Date data is also available in Search Results page as shown below in the Collapsed mode and Search Results Total References 25 General information Excipient Chem ID Excipient Chemica
22. Toxicity Adolescent Children 5 13 Benzyl Alcohol Acute Toxicity Search Results Page 56 Eu US PFI User Guide 7 2 5 Age Age provides numerical entry for age in its corresponding column as shown below Toxieokinetics Infant Tomiooxinetics Unspeched Unspecified Unspecified Benzyl Alcohol Acute Toxicity Adolescent Children Benzyl Alcohol Acute Toxicity 7 2 6 Age Units Displays the unit for Age provides in years months etc as shown below Clinical Data how Hide Clinical Columns E Benzyl Alcohol Benzyl Alcohol Benzyl Alcohol engyl Alcohol Taxicokimetics Toxicokinetics Acute Toxicity Acute Toxicity Infant Unspecified Unspecified Unspecified Adolescent Children 5 13 7 2 7 Gender Displays the gender based on the search criteria in the relevant column as shown below Search Results Page 57 Eu US PFI User Guide Benzyl Alcohol Texicokinetics Infant Benzyl Aleghol Texicokinetics Unepecified Unspecified Unepeciied Unspecified Benzyl Alcohol Acute Toxicity Adolescent Children 5 13 Benzyl Alcohol Acute Toxicity 7 2 8 Route of Exposure or Administration Route of Exposure Administration indicates the part of the body through or into which or the way in which the excipient is introduced will be displayed as shown below Clinical Dala Basin Alcohol Taxicaxinetics Benzyl Alcohol Toxicoxinetics Unspeciied Unspecified Unspecif
23. another option of selecting multiple category related excipients at a time using symbol When user clicks symbol besides the Excipient Name text box then the below pop up window appears gt Select Multiple Excipients Microsoft Internet Explorer provided by GYK BIOSCIENCES Http it F2 21 0 54 6088 Eupri_ 1207 179 getMultipleExcipient jsp selectedCashums selectedsyn Excipient Name Please enter minimum of three characters Aspartame Benzalkonium chloride Benzoic acid Benzyl alcohol Butyl Paraben rr Internet In the Basic Search if user enters required excipient name in the Excipient Name text box Example Ben then only the relevant excipient appears in the drop down as shown below Basic Search Page 24 Eu US PFI User Guide gt Select Multiple Excipients Microsoft Internet Explorer provided by GYK BIOSCIENCES E https 172 21 0 54 8088 Eupri_1207_179 getMultipleExcipient jsp selectedCasNums 8selectedsyn Excipient Name e Please enter minimum of three characters Genzalkonium chloride Sodium benzoate Then user is allowed to select the required excipient from the list and can click gt button then the selected excipient name appears in the empty text box as shown below to gt Select Multiple Excipients Microsoft Internet Explorer provided by GVK BIOSCIENCES E http 172 21 0 54 8088 Eupfi_1207_179 getMultipleExcipient jsp selectedCashu
24. appears in an expanded mode as shown below ale a Piade rnare Coluenng npc Dy Ainiai Paradies iW Treatexent Duration esi Sateen Safety i Tolea Aidwere Eia Doa Form Caa Lama Referemoe Reio Tape r E ___ Bove Peon He Effect Sed BE hale niini T ere La Anite ation H eaim rai Units Taube Lg baer Teberatelity Adere Lecia Daae Form ermee heeren ype S m r il a Barne Pepan Na Eien Set Mot Inbrtet AAR OL tea Lipar isolated Hert Wo EPect Search Results Page 83 Eu US PFI User Guide Mouse hover on more link also displays the complete information of the Dosage Form in a tool tip as shown below spyebhens MHS EERE kipe r Abra Durat on Le resime r Und Deben igan Safety Tebevability A Adverse EMects Daraga For Daimin Ci Reference Reten pe i Beve Pepe Hie Effect Gid Met nhik In Vitro Arsionptin Activey OL More Percregiic Mo Effect Or Lipgse Actety Lipase romed Heat Ho Effect 7 4 13 Conclusion Comments Comments indicate the overall remarks of the references Any remarks or concluding statement could be entered in this section It will be a free text editor field for creating formatted text and tables or inserting any excerpt from a reference Fomo Hidg Invitro CHurna 3 x 5 fa appa Ur Adminai er Dasih Od Treabmeni Duratlon Linits heri Hn Saheiy f Poles ity S Ademe 1 Perks Drage Form Conlon i Lommen Beleren
25. eit aureae eie ho Eee Ge Dogra 2nd Bah he Efe Gr Aah AS DADR Lu Mere osMore Cogntnee dnd Bar i Ha j yee FL ere MeurechyesiogiMeurapsychcig Mo Effie Hawopercholegic Lange Daily Dossi Hore Resuis Aie Turrets T Erg r hae a Unspeohed Urs Saght Nausea Agmerustrater Od Mo EAect of Aspetome Ar 6 Aaeaetese Leading L Hoe aaora Lrigeted Meureingid Behave agree Abispa He Bosthemizal Latii Shearing Ger fadance of Tex p i i J a 7 2 18 References A reference indicates the source from which the information is extracted The references would be linked to their original source through DOI When possible the references would be linked to their original source through DOI The users who need the details of the study will be able to access the abstract or full text depending upon their subscription copyrights limitations Search Results Page 64 Eu US PFI User Guide Conversson Pi More z Me Effect On Sspectame At Greater Cognitive 4nd Than 10 TL Mere Beh More 7 2 19 Reference Type Reference Type Indicator specifies the type of reference e g Study report or Publication Choices include study report company data publication review article or handbook other Sonverhor PL beret Ho Effect On 4 Sepertame AI Greater Cogninve And Thar IG TL Beh Chore 7 3 Non Clinical Data STEP application provides the data of the excipients based on the various aspects one amon
26. of registration To know that information user has to click Why Registration link besides the New User Register Now as shown below New User Register Now Why Registration Revision Date 06 25 2012 EUPFI DATABASE END USER LICENSE AGREEMENT This End User License Agreement shall be governed by the United Kingdom laws without giving effect to principles of A conflict of laws You hereby consent to the exclusive jurisdiction and venue of the courts sitting in London United ungdom to resolve any disputes arising under this End User License Agreement This End User License Agreement contains the complete agreement between the parties with respect to the subject matter hereof and supersedes all poor or contemporaneous agreements or understandings whether oral or written You agree that any varying or additional terms contained in any purchase order or other written notification or document issued by you in relation to The ONLINE STEP DATABASE licensed hereunder shall be of no effect The failure or delay of EuPFI to exercise any of its nghts under this End User License Agreement or upon any breach of this End E Me read the Disclaimer and accepted the Terms amp Conditions User Name Organization Email Address Confirm Email Address Contact Number County Getting started Page 8 Eu US PFI User Guide Then the information appears as shown below New User Register Now Why Registration Revision Date
27. values Please use icon to open lection di box CAS Registry Number one es ic 8 6 6 d Progressive search will be based sail and filtered on the values already ih selected in drapdowns 001 54 5 Synonyms a s per the Handbook of Excipients _ i Alkyldimethylbenzylammenium chloride Function Antimicrobial preservative neti agent Confectionery base Search by Excipient Excipient Name Aspaname B enzoic acid f 7 Please enter minimum of 3 characters to populate suggestions Please use Ctrl Mouse click to select multiple values Please use icon bo open C48 Registry Number parece thems Tear iiaii Progressive search will be based and filtered on the walues already selected in dropdowns Synonyms s per the Handbook of Exciplents benzenecarbexylic acid benzoate benzoylate carboxybenzene ir Select Adsorbent Antimicrobial preservative Coating agent Confectionery base Basic Search Page 23 Eu US PFI User Guide Based on the selected Excipient Name data in the CAS Registry Number Synonyms and Function appears User can use the symbol placed besides the Excipient Name textbox to select multiple excipients randomly 5 1 1 2 Excipient selection based on the category In the basic search page user only has the privilege of selecting Excipients of one category at a time but there is an
28. 00 Mg Kg 3 7 3 11 Route of Exposure Administration Route of Exposure Administration indicates the part of the body through or into which or the way in which the excipient is introduced will be displayed as shown below Non Clinical Data show Hide Non Clinical Columns Dose Concentration Dose Units Route Of Exposure Administratior Duration Of Treatment Duration Units Frequency Of Administration System Organ Adverse Effect a G Kg Ora Unepecified Unspecified Unspecified Plasma Brain Convulsions G Kg Day Oral Weeks Continuous No Effect G Kg Day Weeks Continuous No Effect Ye Gm Eg Weeks Continuous Multi Organ Reduction In Be Waight 2000 4000 Mg Kg t Search Results Page 72 Eu US PFI User Guide 7 3 12 Duration of Treatment Based on the excipient the complete duration of the treatment will appear in the corresponding column as shown below in days weeks or months Non Clinical Data Show Hide Non Clinical Columns Dose Concentration Dase Units Route OF Exposure Administration Duration OF Treatment Duration Units Frequency Of Administration System Organ Adverse Effect i Unspecified Unspecified Unspecified Plasma Brain Convulsions G Ko Bay Continuous No Effect G Kg Day Continuous No Effect 9 24 7 5 Gm Kg 4 Continuous Multi Organ Reduction In S Weight 2000 4000 Mg Kg t 7 3 13 Duration Units Displays duration of the dose in unit
29. 4 Developed by GVK BIO 3 User should save the above information for further reference 4 If user tries to register with the existing Login Email User name then an alert message appears as shown below indicating the user has already existed as shown below New User Register Now Why Registration Revision Date EUPFI DATABASE END USER LICENSE AGREEMENT This End User License Agreement a wn Pa F r L 5 I J r im Sie Wurisechen f der thie End User License Qoreen me compete agreement betas ee ee Aj a E EE beel arl la aF IUTE a rms contained in any purchase eo Po See eS eS eS 2 EE Lee ee ONLINE STEP DATABASE ienser iiras l i by 7 five read the Disclaimer and accepted the Terms amp Conditions UserName Saraswathi Organization GYKBIO Email Aderess saraswathi nimmaraju gvkbio com Confirm Email Address Saraswathi nimmarajug qvkbio com ale i g rT Lai Le Number 924 363934 Getting started Page 12 Eu US PFI User Guide 2 4 Forgot Login Email STEP database provides access to users using Login Email if user forgets the login email can retrieve it very easily using Forgot Login Email link derer database Database of safety and toxicity of excipients for paediatrics I m an Existing Eupfi User 5 User Guide Login Email Login Forgot Login Email 1 Click Forgot Login Email link as shown above then the below page appears
30. E Age Units the Pharmacology Unspecified Unspecified 250 500 1000 Pharmacology i Unspecified Unspecified 50 100 200 Pharmacology Unspecified Unspecified Pharmacology li Unspecified Unspecified Pharmacology Unspecified Unspecified 50 100 7 3 3 Study Type Study Type provides the nature of investigations like randomized controlled cohort case studies etc In this field considering the search criteria given the relevant Study Type appears in the column types as shown below Non Clinical Data how Hide Non Clinical Columns Unspecified Unspecified M 250 500 1000 Unspecified Unspecified i 50 100 200 Unspecified Unspecified Ethanol i i i Unspecified Unspecified Unspecified Unspecified Search Results Page 68 Eu US PFI User Guide 7 3 4 Species Species indicates the animal species used in the experiment Example rabbit rat sheep cat cattle dog gerbil guinea pig hamster monkey mouse pig and other as shown below Non Clinical Data Show Hide Non Clinical Columns Category Age Units Gender Bose f Concentrat il Unspecified 250 500 1000 Pharmacology ice Unspecified Unspecified 50 100 200 Pharmacology i Unspecified Unepecified Pharmacology i Unspecified Unspecified Pharmacology Mi dul Unspecified Unspecified i 50 100 7 3 5 Age Category Age Category provides category in which the age has to be considered on the search criteria
31. E g PFi ser database Burpee Spe T praia in ae a Database of safety and toxicity of excipients for paediatrics Forgot Email Indicates mandatory field User Name Full name the user registered with User ID Get Login Mail Click Here to Login Developed by GYK BIO GOSTAR GCBIOM 2 Enter the User name Full name of the user with which the earlier user was created in the User Name text box Then enter the UserID provided by the application at the time of registration 3 After entering the details click Get Login Mail button as shown below Getting started Page 13 Eu US PFI User Guide Forgot Email Indicates mandatory field User Name Full name the user Saraswathi registered with User IDO Click Here to Login 4 Then the corresponding login Email Id appears as shown below Forgot Email Indicates mandatory field User Name Full name the user Saraswathi registered with Your Login Email id Ils saraswathi nimmarajug avkbia cam Click Here to Login 5 User can access the application using the retrieved Login Email 6 If user enters incorrect User ID in the User ID text box and clicks Get Login Mail button then the application prompts the below message EuPFi eae ee oe Forgot Email Sei Mame IF name The Weer reqsier ed weit Lier i Your Login Email id is Hot Found Please Enter The Connect Dats Je lets To Lees Gett
32. Eu US PFI User Guide European Paediatric Formulation Initiative Eu US PFI Safety and Toxicity of Excipients for Paediatric STEP User Guide European Paediatric Formulation Initiative EuPFI UCL School of Pharmacy 29 39 Brunswick Square London WC1N 1AX www eupfi org Introduction Page 1 Eu US PFI User Guide Contents MAURO 1 eco ers E E A E E A E E E BM YSU NC Wy a E E A E TE A E A EE E E AE EE T E Eo COD e E E bbuatia aed Geece dank uate oat tmeesodnuadnastenesseatoupe est Lo OSS arse aetna tenet eastern E E E De CUI SEATIC E t ome atari cine stesso aitinedsdaretino conmsauase ue netoeesadeeetinnnnecmbooaseueed Dig MOO Ui Med oca eevee shee E E T E E Zid Why Retismo eerren E EET EE TEE EAT 23 Now userre ista Oe E paiva sans onaeeceenys osu canteceeews ogee ncn ceesosenes Zi MOU SOG I Ud WA aes ce tics ctigcns suite acs E T E E S De RS UN U areca ce cer ce escent E E E E PA WWE DG IU AUIS E E E A E E E E E E E E E E BD E a E E E E E E A W EOT E renee are ennrere were rere arene te De SI SA are tee eve coe esecesee ese cei tane ston cuvensnaedecetat scien E AE E al Paea Dy EOD 1 Se nee ene ee ar eee ee Oe SAV ACCC Se AC esha cre E EE DE E T E OL ACT MICA Dilie E E O EEE E E 02 Non Chnical Oat asa ances sosecsscaanutensenecandecon ccssseuaasconsadiasenteead E E EE ES To Pa ERE U A E A E A a o E E E E E E T ae C D 1A E E E E A E E E A A Lo Nowem DA e E E E E E E E E E E E E E E Fo RE e EO ea E E E E E E E S
33. Eu US PFI User Guide Then click Submit button to retrieve the search results considering the search criteria Search Results Total References 25 Record 4 of Encian Navigaton General informaton Gxcpeent Chem I Enoent Chemica Name Bence aboh CAS Registry Humber 1O E 1 6 Exopient Category oncion Pharmacopesial States Regulatory Status Smonyms moteplabee Daily intake Reasion Date Dirica Pi Lt cos vow Hide Clinical Columns Ref iD Focipient Hime Study Type Age Category f Age Units Route Of Exposure Or Administration Rie a a a E E E Senzy Alte piisa sa inai L B nzy Kohei Toeeeorencs Ungpeohad Ursoeofed Unspeohed Lrsoecihed Ore SL pi Benzyl Alechel Aute Taoety nggierceni Children S 13 Yeas FH Orn 3 But here based on the selected Excipient Name the CAS Registry Number and Synonyms gets progressively filtered User is allowed to select the combination of the CAS Registry Number and Synonyms Note gt Based on the selected Excipient Name remaining data in the CAS Registry Number Synonyms appears gt When user selects Excipient Name and CAS Registry Number then based on both those values data in the Synonyms appears gt The above functionality is applicable when user selects any of the value among Excipient Name CAS Registry Number Synonyms based on that remaining data appears
34. I Inhalation PESO ERE ERE ee ee eee ees Antimicrobial preservative Coating agent Confectionery base Page 39 Eu US PFI User Guide 6 1 2 Search by Effect Effect is any undesired action or effect of an excipient it includes the System Organ information on which the effect occurred 6 1 2 1 Organ System Indicates on which organ or system the effects are observed Search by Efect Select Organ System Nasal mucosa Oral cavity Respiratory submit iii sasic search Based on the selected data under Search by Excipients and Search by Effect the search results appears Advanced Search Clinical Data Search For Excipients Acute exposure Acute toxicity Chronic toxicity Dermal toxicity Select Adolescent Age Category Adolescents adults Adult Adults Select Cutaneous Route of Exposure Administration Dermal Closed patch IV Inhalation Select Adsorbent Function Antimicrobial preservative Coating agent Confectionery base Search by Effect Select Immune System Organ System Nasal mucosa Oral cavity Respiratory soom iene tasc searcn Developed by GVK BIO gt Advanced Search Page 40 Eu US PFI User Guide Then the total number of excipients existing for the given search criteria are more than one then it appears as shown below EuPFi
35. Introduction Page 2 9 Eu US PFI User Guide PROV yee theese seed E E E E E T E E 86 T COO E E E S 87 Ped PRONE O er a A E EE E EE 90 7 9 Navigations in Search Results page seenssssssssoeerssssssssseeresssssssserersssssssscereesssssseeeeresssssssees 93 7 10 ING PEC OPUS TOUD eiren EEEE EEE AEE 94 EDON ren a E A E E R A E A E T A A A E E 95 Sbe EPONE ROE ee E A E E A A A E R 98 ON WOE a E E E E E 101 So LATE 010 ee eee eee eee E E ee 104 OS i a E A E E E E E EE 105 Introduction Page 3 Eu US PFI User Guide 1 INTRODUCTION 1 1 Overview European Paediatric Formulation Initiative EuPFI is a consortium working in a pre competitive way on paediatric drug formulations Members are from academia hospital pharmacies pharmaceutical industry Innovators Generics Contract Research Organizations CRO Specials and Excipient Manufacturers with European Medicine Agency EMA as an observer Its main aim and objective is to identify scope issues and challenges in paediatric formulation development in order to raise awareness and facilitate preparation of better safe medicines for children As there is no central repository in public domain that resides all the information on safety and toxicity of Excipients for the paediatric drug development The Eu US PFI has established that there is a pressing need for a single authoritative comprehensive database of adverse effects of excipients for paediatrics STEP Safe
36. Juyenille Ethane Tolerance A Juverille Weeks Ethanol Chronic Toxicity Juyerille Ethanal Developmental i 7 3 9 Dose Concentration Dose s or concentration s tested administered including unit e g 0 112 220 523 mg kg bw day m f or 0 112 220 523 mg kg bw day m will be displayed based on the searched criteria as shown below Non Clinical Data Show Hide Non Clinical Columns E Dose Concentration Dose Units Route Of Exposure Administration Duration Of Treatment Duration Units Frequency Of Administration SystenvOrpan Adverse Ee Fffect bi o a E Oral Unspecified Unspecified Unspecified Plasma Brain Convulsions Continuous No Effect Weexs Continugus No Effect Weeks Continuous Multi Organ Reduction In Br Weight 2000 4000 Search Results Page 71 Eu US PFI User Guide 7 3 10 Dose Units Dose Units represents the relevant dose unit terms of the dose based on the selected search criteria as Shown below Non Clinical Data how Hide Non Clinical Columns 7 ee a es ea ae A Dose Loncentration Dose Units Route Of Exposure Administration Duration Of Ireatment Duration Units Frequency OF Administration System Organ Adverse Litect Unspecified Unspecified Unspecified Plasma Brain Convulsions Weeks Continuous No Effect G Kg Day Weeks Continuous No Effect 9 24 7 Gm Kg Weeks Continuous Multi Organ ee In Bt Weight 2000 40
37. Number B4 17 8 Excipient Categor Function Phamacoposial Status Reguiatory Status E Synonyms Acceptable Daily Intake E Revision Date Non Clinical Data how Hide Non Clinical Columns Ethanol Pharmacology Unspecified Tai Ethanol Pharmacology j Unspecified Unspecified St 10 30 200 Ethanol Neurotoxicity Rat Unspecified Unspecified Unspecified Unspecified When user clicks Ref ID value then the complete reference information appears in a separated tabular format as shown below Pharmacology Unspecified Unspecified Pharmacology j Unspecified Unspecified 5 LO 30 200 Ethanol Neurotoxicity R Unspecified Unspecified Unspecified Unspecified Ethanol Tolerance Juvenille Ethanol Tolerance Juvenile RIF m aiima TLE AUTHOR REFERENCE TYPE YEAR Hg 38 Guzo S Canta A Verzani MA Stasi H Salmana M Romano 5 GaraiimiE Nec Of Aspartame On Secures in Various Modes Of Experimental Epilepsy Tool Appl Pharmacol 96 1988 Po 4857492 Search Results Page 67 Eu US PFI User Guide The Reference information tabular format includes complete information about the related Reference ID Reference information Title Author Reference Type and Year as shown above 7 3 2 Excipient Name Based on the search criteria the relevant Excipient Name appears in the Excipient Name column as shown below Non Clinical Data Show Hide Non Clinical Columns
38. Search For Excipients study Type species Age Category Route of Exposure Administration Function 6 2 1 3 Age Category Eye irritation Immunotoxicity Imunotoxicity Neurotoxicity Ocular toxicity Juvinille Inhalation Intravenous Intravenous infusion Oral Film forming agent Ointment base Sweetening agent Tablet and capsule lubricant antimicrobial agent Age Category indicates is classified as per ICH classification CPMP ICH 2711 99 Based on the age category the relevant group name in indicated here a few group names are Example Adults Juvenile etc Advanced Search Page 44 Eu US PFI User Guide Non Clinical Data Search For Excipients Eye irritation Immunotoxicity Study Type Imunotospcity Neurotoxicity Ocular toxicity Species Age Category Juwinille Inhalation Route of Exposure Administration Intravenous Intravenous infusion Oral Film forming agent Ointment base Function Sweetening agent Tablet and capsule lubricant antimicrobial agent 6 2 1 4 Route of Exposure Administration Route of Exposure Administration indicates the part of the body through or into which or the way in which the excipient is introduced Example Oral Inhalation Dermal Implantation Parenteral Topical Ocular rectal other Select Inhalation Route of Exposure Administration Intravenous Intravenous infusion _ tablet and capsule filler tablet and capsule l
39. The users who need the details of the study will be able to access the abstract or full text depending upon their subscription copyrights limitations Search Results Page 76 Eu US PFI User Guide 7 3 20 Reference Type Reference Type Indicator specifies the type of reference e g Study report or Publication Choices include study report company data publication review article or handbook other 7 4 Invitro data Invitro Data provides the complete information about the v Ref ID Excipient Name Study Type Species Dose Dose Units Route of Exposure or Administration Duration of Treatment Duration Units System Organ Safety Tolerability Adverse Effects Dosage Form Conclusion Comments Reference LS NNN ON NN NR NNN NNN Reference Type 7 4 1 Ref ID Ref ID accommodates the reference ID information of the selected excipient If there is only one record there will be no color differentiation and the page appears as shown below Search Results Page 77 Eu US PFI User Guide ev hada maro Caium E Bef ID Etip Hame Sasscthy Tas pamja Daie Units Asute Cf Experire Or Aiaia Duration H Teeb Charan Eita Faily by a a Beyi alge Fharmacciegy Boring Benz koha Phanmacoogiv Ho Bane keka 6Phanmecelogy ay 2te d Hoh Berd Akobo Phanmeocologv When user clicks Ref ID value then the complete reference information appears in a separated tabular format as shown below G
40. User Guide i aune gesimamnmaLcomn New User Register Now Why Registration Revision Date 1 EUPFI DATABASE END USER LICENSE AGREEMENT Getting started Page 7 Eu US PFI User Guide And clicks Log in button then the below message appears I m an Existing Eupfi User Email ID not yet registered Please register before logging in Forgot Login Email New User Register Now why Registration Revision Date 06 25 2012 EUPFI DATABASE END USER LICENSE AGREEMENT e This End User License Agreement shall be governed by the United Kingdom laws without giving effect to principles of conflict of laws You hereby consent to the exclusive jurisdiction and venue of the courts sitting in London United Kingdom te resolve any disputes arming under this End User License Agreement Ths End User License Agreement contamns the compete agreement between the partes with respect to the subject matter hereof and supersedes all prior or contemporaneous agreements or understandings whether oral or written You agree that any varying or additional terms contained in any purchase onder or other written notification or document issued by you in relation to The ONLINE STEP DATASASE licensed hereunder shall be of no effect The failure or delay of EuPFI to exercise any of its nghts under this End User License Agreement or upon any breach of this End 2 2 Why Registration STEP provides the detailed information about the necessity
41. a Hda iira Apenini Ret D ipleri Hiss Stu af Ty a Dose De lirdi Roete Cf Dapre Or Adara Durathon Of Treated Duration Units 3em pe F 3 z l Alobal E Brecher Bape Akehe Phases ig neuh Bercyl Akehe l Phamnazglagy Retin Phacmecoogs Rabb TIT AGT RR ST CSecE Tet Heine RHET Seas LEHTE E Jue 1978 Avane as Ding Cec PASHA ena Of Apre Dendre Ct fea Oey ERs Der Baek ee ee r The Reference information tabular format includes complete information about the related Reference ID Reference information Title Author Reference Type and Year as shown above 7 4 2 Excipient Name Based on the search criteria the relevant Excipient Name appears in the Excipient Name column as shown below Search Results Page 78 Eu US PFI User Guide HiHat Goer Coume 2 Puri it Eecipoert Hime Study Tee krr Derr Uniti Route Co Expowere Or Admina ration Duration O Treated Duration Unit S O eharmecniogy Bovine 7 4 3 Study Type Study Type provides the nature of investigations like randomized controlled cohort case studies etc in this field considering the search criteria given the relevant Study Type appears in the column types as shown below how Hede Imiro Columns Bal Exctpient Hame Stuy Type T Ecate OF Espoo Or Administration Durston CF Trestovent Dursa Un Sys L EE E
42. al tact x Caas Seed A agpestent Agcarente asus Aduk Aduits x ch aL en Seed A Cutaneous Route of Exposure Administra on Dermal Closed patch af Inhalabon adsorber Puneo lArbmierobal preservatve Costing agent Confectionery base hie ret Search by Eflect na aT no JERA immane System Organ Sistem Nasal mucosa Oral canty a eboeratory Developed by GvK ai ae G BIOM Advanced Search Page 35 Eu US PFI User Guide Advanced Search facilitates user to select the search criteria based on the below aspects v Clinical Data v Non Clinical Data 6 1 Clinical Data STEP application provides the data of the excipients based on the various aspects one among them is the Clinical Data This provides complete optional environment depending on the Clinical Data attributes Clinical Data attributes listed in the STEP database under Advanced Search are 1 Search for Excipients v Study Types v Age Category v Route of Exposure Administration v Function 2 Search by Effect v Organ System 6 1 1 Search for Excipients Search for Excipients includes all the data related to the excipient related to the Study Types Age Category Route of Exposure Administration and Function Based on the data selected under the above categories then relevant Excipients and its related data appears in the search results 6 1 1 1 Study Types
43. ation link then the data gets collapsed and the page appears as shown below New User Register Now Why Registration Revision Date 06 25 2012 EUPFI DATABASE END USER LICENSE AGREEMENT e This End User License Agreement shall be governed by the United Kingdom laws without giving effect to principles of conflict of laws You hereby consent to the exclusive jurisdiction and venue of the courts sitting in London United Kingdom to resolve any disputes arising under this End User License Agreement This End User License Agreement contains the complete agreement between the parties with respect to the subject matter hereof and supersedes all poor or contemporaneous agreements or understandings whether oral or written You agree that any varying or additonal terms contained in any purchase order or other written notification or document issued by you in relation to The ONLINE STEP DATABASE licensed hereunder shall be of no effect The failure or delay of EuPFI to exercise any of its nghts under this End User License Agreement or upon any Breach of this End E Me read the Disclaimer and accepted the Terms amp Conditions User Name Organization Email Address Confirm Email Address Contact Number ciel Getting started Page 9 Eu US PFI User Guide 2 3 New user registration STEP facilitates user to create a new user in a simple way by using the New User Register Now process Here before registering user should chec
44. ch Adsorbent Function Antimicrobial preservative Coating agent Confectionery base 6 1 1 3 Route of Exposure Administration Route of Exposure Administration indicates the part of the body through or into which or the way in which the excipient is introduced Example Cutaneous IV Oral Inhalation Dermal Implantation Parenteral Topical Ocular rectal Intranasal Considering the selected Route of Exposure Administration values the search results appears Advanced Search Page 38 Clinical Data Search For Excipients study Types Age Category Route of Exposure Administration Function 6 1 1 4 Function Functional Data helps to provide the information which is neither Clinical nor Preclinical data It Eu US PFI User Guide Select Acute exp Acute toxicity Chronic toxicity Dermal toxicity Adolescent Adolescents adults Adult Adults Select Cutaneous Dermal Closed patch a Ih Inhalation Dispersing agent Dry powder inhaler carrier Emulsifving agent Filmm forming agent Ointment base facilitates user to access the data based on the function values as shown below Clinical Data Search For Excipients Study Types Age Category Route of Exposure Administration Advanced Search Select Acute exposure Acute toxicity Chronic toxicity Dermal toxicity Adolescent Adolescents adults Adult Adults Select Dermal Closed patch
45. d i Gengu We Time Dutor og h 7 4 10 System Organ Indicates on which organ or system the effects were observed how hades Imiro Coduming 8 ee Ler Briminichretion Garabhon LN reaime r an Lint ari Lee het eea ly f Atam Lect Eg Aei eC ere aes Keere Aele Dee i me din ee Did hoe Ip feoater Tr Viera arogas Papen Arint te fani Deres In Lip hiel Tas maire Lepaname To af a Rava Lahane The Average Eien Dea Ell eed Com Coagulation iva Toma O LHe 7 4 11 Safety Tolerability adverse effects It displays the adverse effects that are in the excipient appears in this column as shown below ow rhe maro Coar E krae Oy Ae iea ara ha H eala Certo Uea So Sai Sate f eera Adverse beci brie Porm Caner Coens Relererete Reference pe ee it Mok Tah in Wikre Antari Pepen Aaner Of Mere Aspe tame The Abhity Of Wad Dette Agpartame Te Af En Flee Loblere LMt The swerage Effect On Bised Coagulkion Coaguianon Ma Tene O Latham Search Results Page 82 Eu US PFI User Guide 7 4 12 Dosage Form Describe the results of examinations based on free text template delete add elements as appropriate as Shown below pahede reir Columna pure Oe Adeninistration Duration Ol Treatment Dori nii Sabem a Safety Toei d ea Ee Dege bor Contini Cormeen Reference Reference yp When user clicks more link the complete information about the Dosage Form
46. e Hes Agavratranon Of Mo Effect OF Aa pe Tae At Aisi Tint Leddy i Jie re Legeeohed Neuritic Berea GAIE Airit Ho Bescherncal otic fhenr Con Badgace Of Tox i Me re F Bice an Mouse hover on more link also displays the complete information of the Adverse Effects in a tool tip as shown below Show Hide Chin cal Cohan CA Treated Draien Units Proeqgurncy 0E ddimininiration Dale Crean alete i Tolierebliby Aore Effects Deeg Form Donchian Comment Reference Reie Ce OOOO O a CEER PC Mare WEEER Single Neuroptyesegec Meuroprychelo No Peg on Cepecve dnd Beh Ho Eec On epg ij AEREE n ee Tran 20 TL Mare 3 Times Geely Heurin Neuropsycholo No His gs eee i ier Leger Dady Cones i 2 Cahora Ee Tinet TL Hea Lesoecrhita Shoht Hauses Admunatiraven OF Na Hez Of Agata at Aspaceme Leading More i More Et heurtiogic Bahmal Geir aL apa rde M Bape Luong tecylanine Con Evidence Of Tom j Ha at r bene Search Results Page 62 Eu US PFI User Guide 7 2 16 Dosage Form Describe the results of examinations based on free text template delete add elements as appropriate as Shown below taw Hide Clrecal Coburn hatha Urita Frap OF Anhaia lb gan datiy f Terai eee Lee ek eee eee Adee Elfesis Dege Fearn Singie eel fie Eien Ge Seer and Sehl Pease Heuraph einige Meunepayehols Mo Effect 4 Copie Sra Bek Es ai Piss ei A bai t Tiresa Dady ligurdeh
47. e j eF piigi Ej Bean Akaka a a e e e Eybi Ojas m Search Results Page 80 Eu US PFI User Guide 7 4 7 Route of Exposure or Administration Route of Exposure Administration indicates the part of the body through or into which or the way in which the excipient is introduced will be displayed as shown below ow Hede Imiro Columns E rt Fardphent Hemy Study Type Dye Linha Ecoute W Tapers Ur ddenioidreticon Duration CH Treatment oration Units a a E M O Benzyl dlpohod 7 4 8 Duration of Treatment Based on the excipient the complete duration of the treatment will appear in the corresponding column as shown below in days weeks or months how hee miro Churiy becipend Hie Stuy ape pet D Wir ts Route OF Ex prae Oy Aani Chretien OF Trewiaernt br Unidas ee eV Phacniecciogy Genre sigh Fhecmecciogy HE Higi inguiaticn Benz akg Phpetmapcolegy a Hg 7 4 9 Duration Units Displays duration of the dose in units Search Results Page 81 Eu US PFI User Guide ow Hade nate Costumes Tae Oe ddeninivtration Darai 08 Treaieent Daratan Und para on Cages Colety A Teherabetity i Adhere Eet Dorp Form Corehnian J Coeeienit Referees Referee Type E a ee lt Me Effect fed Met inhibe be vire Artptpen No Pifect On ipase Adiitr aai Cecrcace IA Lip More ho Effect ispaname The abiy OF Gad Dec Aapariame Te af an Free Latii LoMore The Average Elien On Bloo
48. elp users to identify the references where two or more studies are discussed in one reference When user clicks Ref ID link in the Reviews table as shown below Search Results Page 86 Eu US PFI User Guide Reviews Reference REF iD REFERENCE AvTHOR REFERENCE TYPE YEAR Maher TJ Wurtman RJ Possible Neurologic Effects Of Aspartame A Widely Used Food Additive Environ Health Perspect 1567 Nov 75 53 7 Review Publted PMli0 3319565 PubMed Central PMCD PUCT474447 Then the entire information of the reference appears as a tabular separate with the Ref ID Reference Title Author Reference Type and Year information as shown above 7 7 Customization In the STEP application user is allowed to customize the excipient selection by selecting more than one excipient using Basic Search as shown below using CTRL key Search by Excipient ne ke k j SAT p on p Excipient Name k Please enter minimum of 3 characters to populate Suggestions Senzalkonium chloride Please use Ctrl Mouse dick to benze acd select multiple values Benzyl alcohol Please use icon to open selection dialog boo CAS Registry Number Progressive search will be based and filtered on the values already selected in dropdowns Synonyms As per the Handbook of Excipients ji vinyl 2 pyrrolidinone polymer 1 2 Benzenedicarboxylic acid dimethyl ester 1 2 Drethy phthalate
49. es Fron the Internet can be useful some files can potentially harm vour computer IF vou do not trust the source do not oper or save this file What s the risk User can open or save or cancel the file download using Open Save Cancel button When user clicks Open button as shown below File Download Do you want to open or save this file pa Name EupriExportResults pdf tobe Type Adobe Acrobat Document From infwwroyd pen _ ET While files from the Internet can be useful some files can potentially harm your computer IF you do not trust the source do not open or save this tile What s the risk Then the PDF appears with the selected data as shown below Export Page 102 Eu US PFI User Guide Edit view Document Tools Window Help ELE S Ja eels fej a ft ral Information Excipient Name Be alcohol Excipient Category Function Antimicrobial preservative disinfectant solvent Pharmacopoeial Status JP XV USP32 NF27 PhEur 6 5 Regulatory Status Included in the FDA Inactive Ingredients Database dental injections oral capsules solutions and tablets topical and vaginal preparations Included in parenteral and nonparenteral medicines licensed in the UK Included in the Canadian List of Acceptable Non medicinal Ingredients Synonyms alpha hydroxytoluene benzylic alcohol hydroxymethylbenzene phenmethylol phenylcarbinol phenyimethanol First page Search Inputs
50. g them is the Non Clinical Data This provides complete optional environment depending on the Non Clinical Data attributes Y Ref ID v Excipient Name Y Study Type Vv Species v Age Category v Age v Age Units Gender Search Results Page 65 Eu US PFI User Guide Y Dose Concentration v Dose Units Y Route of Exposure Administration Y Duration Of Treatment v Duration Units v Frequency Of Administration v System Organ v Adverse Effect Y Dosage Form Y Conclusion Comments v Reference v Reference Type 7 3 1 Ref ID Ref ID accommodates the reference ID information of the selected excipient If there is only one record there will be no color differentiation and the page appears as shown below Non Clinical Data Show Hide Non Clinical Columns H Age Units Gender Dose Concentratia Ethanol Tolerance Juvenille Ethancl Tolerance ti Juvenille Ethanal Chronic Toxicity Juvenille Developmental Toxicity Search Results Page 66 Eu US PFI User Guide If there are multiple excipients records then the navigation links appears in the search results page And all the references of first record appears as and the color differentiation is also included to provide the variation in reference data as shown below Search Results Total Refarances 57 Record 4 of d Exciplent Navigation General information Excipient Chem ID Go aae a wish Excipient Chemical Hame Eihanal CAS Registry
51. ht 2000 4000 Malka Search Results Page 74 Eu US PFI User Guide 7 3 16 Adverse Effect It displays the adverse effects that are in the excipient appears in the above column OW Hine aint Enla ninsi dorsi tvs tration Chart lon CA Treatment Duration Units Frequency OF ddeinistration Stem rgan Ahere Effect Dogs Form Gonchiston Comments Reference Reference Type Fi Lirnggeohed Kidney Lever Heptepatheleserad Changed A L Bale agi Re ee cau Wag Ae Te Eartoae induce Peposure Can C utian Pi La j Lin 7 Lg On Forst Gay And 49 On Huscutar A Dosage Of SecoL Mare Weakness 1430 Hg O Sofun Mere Une A Cosy i ETH iire Cary mil Pa a La ea y 7 3 17 Dosage Form Describe the results of examinations based on free text template delete add elements as appropriate Describe the results of examinations based on free text template delete add elements as appropriate as shown below Show Hide Non Clinical Columns Administration Duration WH Treatment Duration Unii Frequency OF Administration bem rgs kieno EMi D Fom Conclusion Comments Relerence Reference T Il Kray Lever Hinooathologi zal NOME Changes A L Fatum Wat able To Em HEE TMH Exeegure Can hiareiaan Haaj f biora ig On First Gay And 4g Or Hups A Dosage Cf Saco Mang sakroj Ard 1530 Hg oe Hees Sedum More More Onee amp Say Ts Eachema and Daily Edema Apglicabor Whe
52. iD P Phanmacopoeial Saus lacceptable Daity intake tor Pediatrics Oretip Ape dose Ll Frequency Of Administration C Condusion Comments RefiD CH Species L Gender C Duration Of Treatment Cl Safety Tolerability Adverse Effects Reference Troe Ret Dose C duration Unit fv Conclusion Comments User Guide LICAS Registry Number l Regutatoy Status T Revision Date Encipiert Name J Age Units CL Dose Units Li SystemsOngan Cl Reference Evciplent Name Cige Lidose C Duration Unit Odosage Fom Excipienthiame C Dese Units I System Organ Reference Excipient Name Sinonims L Study Tipe Gender Duration Of Treatment C Safety Tolerability Adverse Effects v Reference Type Stat Type Age Units Dose Units Frequency Of Administration C Conclusion Comments El Study Type Roue Of Exposure Or Administration C Satety Tolerability Adverse Effects Do you want to open or save this hile Mame EupriExportResulkts xls Type Microsoft Office Excel 97 2003 Worksheet From inFwFoyv9 Open Save i o Cancel while files from the Internet can be useful some files can potentially harm vour computer IF you do not trust the source do not open or save this file What s the risk Export Page 99 Eu US PFI User Guide User can open or save or cancel the file download using Open Save Cancel button When user clicks Open button as shown below File
53. ide Clinical Columns gt Ref ID Excipient Name Study Type Age Category Age Units Gender Route Of Exposure Or Administration M a a a E a Polysorbate 0 Infants Weeks Linspecified Polytorbate 80 Sensitization Adolescents Adults 0 gt 60 ear 7 Dermal Closed Patch Advanced Search Page 48 Eu US PFI User Guide 7 SEARCH RESULTS Based on the search criteria given in the basic search page search results page appears STEP provides the Data in the search results page in a user friendly manner Search Results page is universal when user selects the search criteria either from Basic Search or from Advanced Search Example If user selects Excipient Name as Benzyl alcohol CAS Registry Number as 100 51 6 and Synonyms as Benzylic alcohol and clicks Submit button as shown below Search by Excipient Excipient Name Pease enter minimum of 3 a Select F chara cters to populate Aspantams suggestions Benzalkonium chloride Benzore acid Benzyl alcohol Please use Ciri House click to select multiple values Please use icon to open selection dialog bax CaS Registry Number Progressive search will be based and filtered on the values already selected in dropdowns amanms As per the Handbook of Excipients 1 vinyl 2 pyrrolidinone polymer 2 Benzenedicarboxylic acid dimethyl ester 2 Diethy phthalate 2 propanedial 1
54. ied Unspecified Benzyl Alcohol Acute Toxicity Adolescent Children 5 13 Benzyl Alconol Acute Toxicity 7 2 9 Dose Dose s or concentration s tested administered including unit e g 0 112 220 523 mg kg bw day m f or 0 112 220 523 mg kg bw day m will be displayed based on the searched criteria as shown below Search Results Page 58 Eu US PFI User Guide Clinical Data Duration Of Treatment Duration Units Frequency Of Administration System Organ Unspectied Unspecified 3 Times Day For 2 Days Weeks Single Neurophysiclogic Neuropsycnole No Effect On Cognitive And Beh u More u More 3 Times Daily Neurophysiclogic Neuropsycholo No Effect L More 7 2 10 Dose Units Dose Units represents the relevant dose unit terms of the dose based on the selected search criteria as Shown below Clinical Dala Unspecified Unspecified 3 Times Day For 2 Days Neurophysiclogi Neurepsycholo No Effect On Cognitive And Beh lore a More Mg Kg Bw Day j 3 Times Daily Neurophysiologic Neuropsycholo No Effect Mal rej bbe tite Mel HiL 7 2 11 Duration of Treatment Based on the excipient the complete duration of the treatment will appear in the corresponding column as shown below in days weeks or months Search Results Page 59 Eu US PFI User Guide Clinical Data i Show Hide Clinical Columns Duration Of Treatment Duration Units Frequency OF Administration System O
55. iige Nijaga He Efer Ca Mernj spete av rad Urdgeohed Unia hs jiii Adrina C A Sears at EERTE T Undoadiad Traces Con hgurgecgis Eahaviarsl aging pF Horgj When user clicks expanded mode as shown below howe Cheal Cokimnig E Teral d Aches Eet mag F rT Ha Effect Gn Coprire And Beh Ah i H Dhr Linite Erapey CW Adminebratkhii KM LS rgen taney j 1 i PLT ag aL See lee F kja bi d Zas nipan H ee Efed On Cigane And eias mia Status Arg Linea ey Eker ated Of ee a Bete boboes In Children ARE a bE eure ps pohaieaic Raul She L M5 eel Neurephyarcloge Heoapepohele Me Effect Latii User can click Less link to close the expanded mode as shown below Shopi hebde Chretal Coming Siei f Tolerability A Adeera Effects Doge Form al aai Drath Levis Frequency H Adminabratien Srem aa Dreja Ho Eeri Cri na d Meharia Dihu ij UFAA EAA Sates OF Morrperaas ope eMerebetes Di Thdr Wi apo MeuceetycPelaget Ho Effen Ga reer Srg Beh AEAT herephy pta uror E Ti i heehee urepe OF Msa Ape Agua Le Search Results Meu regdy hele A Cariho Camat Reference heeren Type m Convene Ai one Agnactamhe AL Deter Thee 10 TL Mersi Large Dady Cadea i 22 Teret TL Mee He Eos pe pTe cadira i e He EkchemHal Pymience Of Tox Harg Cd ern L eer Ape At Graber Thar 30 Ti Here Lenge Daty Doser i 20 Tied TL Mac f
56. ing started Page 14 Eu US PFI User Guide Stating that Your Login Email id is not Found Please Enter the Correct Data 7 To avoid this message it s recommended to save the User ID after registration as a new user 2 5 Regular User STEP provides a new option for the regular user who ever are visited more than 25 times can provide Feedback on the application using feedback form Whenever user logins into the application more than 25times then for the next time feedback appears as shown below EUPFI derer database Database of safety and toxicity of excipients for paediatrics FeedBack Form SI No Question Answer How do you know about this site ls it useful for you skip This Page Developed by GVK RIO User is recommended to fill the feedback form with the relevant information then a message box appears as an acknowledgement for submitting the feedback as shown below Windows Internet Explorer Eg hy J Thanks For Submitting Your FeedBack Cancel Getting started Page 15 Eu US PFI User Guide Then click Ok on the message box then Basic Search page appears If user is not interested in filling the form then can skip this page using Skip This Page link as shown below E y PF i bau database Pagan T oenina st Pea of ett and toxicity of excipients FeedBack Form aa Question How do you know aboutthis site Is it useful for you
57. inical Columns gysten Urgan Unspecified Unspecified Unspecified Unspecified 3 Times Day For 2 Days Neurophysiologic Neuropsycholo No Effect On Cognitive And Beh More More 3 Times Daily Neurophysiclogic Neuropsychol No Effect 7 2 15 Safety Tolerability adverse effects It displays the adverse effects that are in the excipient appears in this column as shown below Search Results Page 61 Eu US PFI User Guide Show Hide Clinical Columns E Duration Of Treatment Duration Units System Organ Safety Tolerability Adverse Effects Re Unspecified A Unspecified Unspecitied Unspecified Unspecahied 3 Times Day For 2 Days Weeks Neurophysiclogic Neuropsycholo No Effect Gn Cognitive And Beh Morei More 3 Times Daily Neurophysiclogic Meuropsycholo No Effect Laa Hore When user clicks more link then the complete information about the adverse effects appears as shown below fi Hade Cira Columns E J z 5 usc z i x ae A oe a ee ee Uniti Freqacrey Cf Adminintratien S4vtere icpan faety 7 Toeri iy i baere Effects Drage Form Concho j Comment Eriermer irie z Daraar More ne eehysiglsge tie apero Ne Effect Oe F ho Heg On aaoeteme af Sree Li Pere fsa Hore Cognit dnd That 20 TL Bere Bebi blnew Times Dafy Hoeophyseloge tevoosrchelg Mo Effect Reveoperchelogec Large Deady Doses i 20 Lutong esuke Art Tareas TL Mere f he zj Leepecded lingspeohed Shor
58. ipients However in practice few excipients meet these criteria 5 1 1 Excipient Name STEP endow with Excipient based search functionality for the end users to attain relevant results In the Basic Search page user can select the required excipient name from the Excipient Name drop down as shown below Search by Excipient eae M peny alcohol t lease enter minimum of 3 Select characters to populate Apartame suggestions Benzalkonium chloride xi Please use Ctrl Mousa click to Benzoic acid select multiple values Please use icon to open CAS Registry Number selection dialog box Progressive search will bo based and filtered on the values already selected in dropdowns Synonyms AS per the Handbook of Excipients alpha hydroxytoluene benzylic alcohol hydroxymethy lbenzene phenmethylol phenylcarbinel Function Select Adsorbent Antimicrobial preservative Coating agent Confectionery base i Reset Advanced Search Basic Search Page 22 Eu US PFI User Guide 5 1 1 1 Multiple Excipient selection To add more than one excipient user can use CTRL button and then select the excipients from the drop down either continuously or randomly as shown below Search by Excipient Exciplari Name i i col Ploase enter minimum of 3 characters to populate suggestions Please use Ctrl Mouse click to select multiple
59. k the I ve read the disclaimer and accepted the Terms amp Conditions then the new user registration form then only the Register button appears in enabled mode as shown below New User Register Now why Registration Revision Dale 1 In this page user need to specify the required details for registering as a new user After filling all the details click Register button as shown below Getting started Page 10 Eu US PFI User Guide New User Register Now avm ation Revision Date EUPFI DATABASE END USER LICENSE AGREEMENT ve read the Dis aaimer and acceptad the Terms amp Conditions Saraswathi anizator Gvykbio Saraswathi nimmarajwa gvkbio com imm Ema is saraswat nimmarajue gvkbic com 9247363934 l India Note gt User Name and Email Address are the mandatory fields gt If user doesn t enters User Name and clicks Register button then the below alert message appears Windows Internet Explorer Eg A Please Enter the Username gt If user doesn t enters Email Address and clicks Register button then the below alert message appears Windows Internet Explorer Eg nN Please Enter khe Ernaillid Getting started Page 11 Eu US PFI User Guide 2 Then the user gets registered and an acknowledgement message appears as shown below along with all the users information Saraswathi nimmarajuagkbio com 140 Saraswathi Gkbig India 9247 35398
60. l Name Benzyl alcohol CAS Registry Number 100 61 6 Excipient CategorFunction Pharmacopoelal Status Regulatory Status H Synonyms Acceptable Daily Intake H Revision Date Whenever user clicks symbol before the fields then the corresponding data appears as shown below Search Results Total References 27 Record 1 of 1 Excipient Navigation General Information Excipient Chem ID Excipient Chemical Name Benzyl alcohol CAS Registry Number 100 51 6 l Excipient Category Function Antimicrobial preservative disinfectant solvent Pharmacopoeial Status JP XV USP32 NF27 PhEur 6 5 Regulatory Status Included in the FDA Inactive Ingredients Database dental injections oral capsules solutions and tablets topical and vaginal preparations Included in parenteral and nonparenteral medicines licensed in the UK Included in the Canadian List of Acceptable Non medicinal Ingredients Synonyms alpha hydroxytoluene benzylic alcohol hydroxymethylbenzene phenmethylol phenylcarbinol phenylmethanol E Acceptable Daily Intake General Acceptable Daily Intake Acceptable Daily Intake for Pediatrics 0 5 mg kg bw 1996 N A E Revision Date N A Note Acceptable Daily Intake provides information of both General Acceptable Daily Intake and Acceptable Daily Intake for Pediatrics Search Results Page 52 Eu US PFI User Guide Total References 27 Record 1 of 1 Excipient Navigatior Genera
61. l information Excipient Chem ID Excipient Chemical Name Benzyl alcohol CAS Registry Number 100 51 6 Excipient Categor Function Antimicrobial preservative disinfectant solvent Phanmacopoeial Status JP XV USP32 NF27 PhEur 6 5 E Regulatory Status Included in the FDA Inactive Ingredients Database dental injections oral capsules solutions and tablets topical and vaginal preparations Included in parenteral and nonparenteral medicines licensed in the UK Included in the Canadian List of Acceptable Non medicinal ingredients Synonyms alpha hydroxytoluene benzylic alcohol hydroxymethyibenzene phenmethylol phenylcarbinol phenyimethano l E Acceptable Daily Intake eneral Acceptable Daily Intake Acceptable Daily Intake for Pediatrics 0 5 mg kg bw 1996 NIA Revision Date 7 2 Clinical Data Clinical data provides complete Clinical information of the excipient that includes the below data Y Ref ID v Excipient Name Y Study Type v Age Category v Age v Age Units v Gender Y Route of Exposure or Administration v Dose Y Dose Units v Duration of Treatment Y Duration Units Search Results Page 53 Eu US PFI User Guide v Frequency of Administration v System Organ Y Safety Tolerability Adverse Effects v Dosage Form Y Conclusion Comments v Reference v Reference Type 7 2 1 Ref ID Ref ID accommodates the reference ID information of the selected excipient If there is only one record the
62. ministration dese s Unit C Duration Of Treatment C Duration Une Frequency Of Administration bestemvOrgan C Satety Tolerability Adverse Efects C Dosage Ferm C Condusion Comments C Reference Type Non Clinical Data Dal ORefio Excipient Name Study Tipe Clewposure Period C Species Dige Cage Units Chae Category O Gender Dose Dose Units C Route Of Exposure Or Administration C Duration Of Treatment O Duration Unit Frequency Of Administration Ci Safety Tolerability Adverse Eflacts J Dosage Form Cl Condusion Comments O Study Type CI Route Of Exposure Or Administration C Safety Toterability Adverse Effects Doosage Form C Conclusion t Comments Reference Type Reference DiReterence Then select the required fields using the check boxes then after selecting the required fields using the check boxes clicks Export to Excel to export the data in excel format or Export to PDF to export the data in PDF format Export Page 96 Eu US PFI User Guide F Acceptatie Dady Intake for Pediatrics Oreo Ospe a OD Gender Cose C Duration Ot Treatment CiFrequency Of administraten C Safety Tolerability Adverse Effects Dicondusion Comments Rete ElReterence Tipe Export Page 97 Eu US PFI User Guide 8 1 Export to Excel When user selects Export to Excel button from the Select to Export page as shown below Select to Export fa Ai C Excipient iD Excipient Name Mexci
63. ms eselectedSyn Excipient Name benz Please enter minimum of three characters Benzalkonium chloride Benzyl alcohol Benzoic acid Sodium benzoate Basic Search Page 25 Eu US PFI User Guide If user needs to select any other excipient from another category can again enter the excipient name then the relevant excipients list appears as shown below al f gt Select Multiple Excipients Microsoft Internet Explorer provided by GVK BIOSCIENCES E http i72 21 0 54 8088 Eupfi_1207_179foetMultipleExcipient isp selectedCasNums SselectedSyn Excipient Name Rises pro Please enter minimum of three characters Propyl paraben Benzyl alcohol Propylene glycol F Internet Then user can select the required excipient from the list and click gt button to add it then it appears along with the earlier selected excipient as shown below Select Multiple Excipients Microsoft Internet Explorer provided by GVK BIOSCIENCES ae Atta ffi 2 21 0 54 8088 Eupri_i 207 1 7igetMultipleEscipient jsprselectedCashums 8selectedsyn Excipient Name Please enter minganum of three characters Fropyl paraben CE internet Basic Search Page 26 Eu US PFI User Guide Click Ok button then the selected search criteria appears in the Basic Search page as shown below Search by Excipient Excipient Name CAS Registry Number Synonyms As per the Handbook of Excipien
64. ms is also facilitated When user selects synonyms using Synonyms then based on that selected synonyms remaining data in the Excipient Name CAS Registry Number appears as shown below Basic Search Page 31 Eu US PFI User Guide Basic Search page before selecting the Synonyms Search by Excipient Excioient Name Please onter minimum of 3 j Selets characters to populate Aspartame 7 suggestions Benzalkonium chloride Benzoic acid Benzyl alcohol Please use Chel Mouse click to select multiple values Please use icon to open z j selection dialog box CAS Registry Number A Progressive search will be based and filtered on the values already selected in dropdowns Select 1UU 51 6 131 11 3 1919 77 39 16791 55 8 Synonyms s per the Handbook of Excipients Select 1 vinyl 2 pyrrelidinone polymer 1 2 Benzenedicarboxylic acid dimethyl ester 1 2 Diethy phthalate 1 propanedial Function Select Adsorbent Antimicrobial preservative Coating agent Confectionery base stn advanced Search Basic Search page after selecting the Synonyms After selecting the entire required values click Submit button then the search results page appears as shown below Example Excipient Name Benzyl alcohol CAS Registry Number 100 51 6 Synonyms Benzylic alcohol then click Submit as shown below Basic Search Page 32
65. n a computer monitor and that allows the end user to interact with the system with commands and mechanisms to control system operation and input data User Manual A formal document that contains all essential information for the user to make full use of the new or upgraded system Glossary Page 106
66. n the paediatric subpopulations and also assists in need of generating new data for padeatric medicines Getting started Page 5 Eu US PFI User Guide 2 GETTING STARTED Currently most of the existing databases are focusing in providing Safety and Toxicity related information related only to adults and animals But very few include the paediatric information related to children Consequently there is an acute need for a single repository to capture archive validate manage maintain and provide access to safety tolerability and toxicity data that have been generated for excipients available world wide for paediatric drug development In order to address this need the European Eu and United States US Paediatric Formulation Initiatives PFIs are working together to create and maintain a database of Safety and Toxicity of Excipients for Paediatrics STEP 2 1 Login STEP login page appears as shown below I m an Existing Eupfi User Forgot Login Email New User Register Now why Registration Revision Date 06 25 2012 EVPFI DATABASE END USER LICENSE AGREEMENT A ee oe grts under this E Getting started Page 6 Eu US PFI User Guide When user clicks Log in button without entering Login Email then an alert message appears as Shown below Windows Internet Explorer Eg A Please Enter the Login Email If user logins with unregistered Login Email as shown below l m an Existing Eupfi User TO
67. n user clicks More link then the complete information appears in expanded mode as below Search Results Page 75 Eu US PFI User Guide hon Pode Aon Ciney Canna E Adenine ei Duration CH Treeline Dearie Urata Fiag Of Aart Sabena kiere Ei Der rape Far Dilinin erm Belee Reborn Tie i ig Gn Fire Day puje ula L Gossage Of a H Hgphir pi ani gusen PR ie a Dat Eryrhacus Sad fdir bienale ipar User can click Less link to close the expanded mode When user places mouse hover on More link then the detailed information appears in a tool tip as shown below eevee Ron Chri a Chum E a 7 z F a Ainiai r Of eai rabh Wears Frequency Of inean Sabem gan Aee Ei Dog Form Caha Commenta Reference Reference Type ie Po eculer a ls ee Ang AGERE re i Eo thar Ard Egam Unspached orang ate bn bresa ala E uh Lreneccnd Hemar be PRT Edel Mone 7 3 18 Conclusion Comments Comments indicate the overall remarks of the references Any remarks or concluding statement could be entered in this section It will be a free text editor field for creating formatted text and tables or inserting any excerpt from a reference 7 3 19 Reference A reference indicates the source from which the information is extracted The references would be linked to their original source through DOI When possible the references would be linked to their original source through DOI
68. nly these navigation links appears using which user can view the search results information of the related excipient Based on the selection initially Benzalkonium chloride information is displaying as shown below Search Results Page 93 Eu US PFI User Guide And on clicking the Next navigation link other excipient Benzoic acid information appears as shown below Search Results Total References 34 Record 2 of 2 Excipient Navigation i o Peepe etal 2 Go agus Previous gt Next Last Excipient Chemical Name CAS Registry Number B5 85 0 4 Excipient CateganiFunction Pharmacopoeial Status W Regulatory Status a Synonyms Acceptable Daily Intake Revision Date Clinical Data Show Hide Clinical Columns Benzoic Acid Chronic Toxicity Adults 54 98 Years FM Intraocular Benzoic Acid Leng Term Adults Unspecified Unspecitied Intranasal 7 10 No records found If there is no data available then the below message appears Non Clinical Data No Records Found Export Page 94 Eu US PFI User Guide 8 EXPORT STEP is also accommodating users to export the required information using the Export link from the main menu bar from the Search Results page as shown below Search Results Total References 27 Record 1 of2 Excipient Navigation General Information Excipient Chem ID ets aries Previous gt Next tLast pa Pira TeyiULs ae Lasi Excipient Chemical Name Ben
69. ns F Ref ID epia excipient Name came d ean Route Of Exposure Or Administration Duration OFT ral 0 00005 0 0001 0 0005 0 00 Incubation idel F Dose Units More Route of Exposure or Administration Lis Benzalkonium Corneal Toxicity Human 0 02 0 01 i Incubation Chloride Benzaikonium Corneal Toxicity Human 0 02 0 01 i Incubation Chloride Berzalkonium Cytotoxicity zabit 0 027 0 01 0 005 Topical i Chinride b J User is allowed to customize the required columns to display the information using the check boxes as shown below Search Results Page 91 Eu US PFI User Guide Invitro Data mon Ut Treatment Duration Units System Organ Safety Tolerability Adverse tiftects ResutFin L Human Comeal Cytotoxic Effects DNA Damage Even At Lo _ Epithelial Cells Concentrat fi IT Route of Exposure or Administration Mare Col More Corneal Toxicity 0 02 0 01 Cornea Endothelium Slight Clarification Of The Eni More Caused On Slight Clari More Corneal Toxicity 0 02 0 01 y5 Cornea Endothelium Slight Clanfication Of The Eni More Caused On Slight Clari attire l Cytotoxicity 0 02 0 01 0 005 Minutes Cornea Significant Corneal Supert Ici LOEL 0 01 F rara azAiiAma When user selects the required columns then the page gets refreshed and search results page only displays the selected columns as shown below Invitro Data Show Hide Invitro Columns
70. on Safety Tolerability Adverse Effects Then the export page gets cancelled and the application navigates to the Search Results page Page 104 Eu US PFI User Guide 9 GLOSSARY Attribute In data modeling specific items of data that can be collected for a class Availability The degree to which a system or system component is operational and accessible when required for use Capacity A measure of the amount of input a system could process and or amount of work a system can perform for example number of users number of reports to be generated Document Written and or graphical information describing defining specifying reporting or certifying activities requirements procedures reviews or results End user The ultimate consumer of a product especially the one for whom the product has been designed End users for STEP database application include Pharmaceutical Scientists Regulators Toxicologists physicians nurses epidemiologists health care providers etc Entity Represents data attributes about which data are collected and maintained Functional Requirement A description of what a system should be able to do a function it should perform Life Cycle All the steps or phases a project passes through during its system life from concept development to disposition Methodology A set of methods procedures and standards that define the approach for completing a system development or maintenance p
71. on Clinical Data Search For Excipients age Category Route of Exposure Administration Funcion Search by Effect Organ System Select A ACLS toxicity Acute toxicity Carcinogenicity Chroree toxicity bt Select A lice Rabbit Rabii b Select F Adult Adults Juvenille Juvirulle bl Select Fe Inhalation Intravenous Intravenous infusion Cra we Select A Adsorbent Antrmerocbial preservative Coating agent Confectionery base w Select Pe Wdrmney Srain Cellular system Central Nervous System i Then Search Results page appears with the corresponding results But if there are more than one excipient exists for the given search criteria then the below page appears Advanced Search Page 47 Eu US PFI User Guide Number of Exciprent found C all ClFropyi paraben C polysorbate 80 Submit vom Developed by GVK BIO And in the above page user is allowed to select the required excipient using the check boxes and then click Submit button as shown below Number of Excipient found 2 C all Propyl paraben Wb olysorbate o Total References 35 General information Excipient Chem ID Excipient Chemical Name Polysorbate 80 CAS Registry Humber 8005 65 56 Excipient Categon Function Pharmacopoeial Status Regulatory Status Synonyms Acceptable Daily Intake Revision Date how H
72. pient Category Function Phanmacopoeial Status 1 synonjms l General Acceptable Dally intake Acceptable Dat Intake for Petits E Clinical Data Om Oren C Study Type Age Category Clage Gender C Route of Exposure Or Administraton C Dose Duration Of Treatment C Duration Uni Frequency Of Administration C Safet Tolerability Adverse Effects C Dosape Fom C Condusion Comments l Reference Type Refi Excipi Cl Study Type Cl species Cage Units CO cender Dese Units C Route of Exposure Or Administration C Duration Of Treatment Frequency Of Administration C SystemOrgan l satety Tolerability thdverse Effects C Condusion Comments Reference Reference Tere E Invitro Data Dal WiRetio v Study Type Species CiDose v Rowe Of Exposure Or Administration Fl Duration Of Treatment C Duration Unit Saketi Tolerability Adverse Effects MDosage Form Conclusion Comments C Reference Type E Reference Fl Reference Export Page 98 Select to Export General Information Lal v Excipient CategonsFunction General Acceptable Daily Intake Clinical Data Oat Ll Age Category C Route Of Exposure Or Administragon C Duration Una Cl Dosage Fom Non Clinical Data Dal Cl Exposure Period Cage Category Route Of Exposure Or Administration OisystemiOrgan Reference Invitro Data Dau iv Species F Duration Of Treatment Fl Dosage Form _ Reference Tipe Fl Reference Eu US PFI l Exciptent
73. provides the information about the search criteria given by the user and based on the categorization data in the PDF appears in separate pages Export Page 103 Eu US PFI User Guide 8 3 Cancel Export User can cancel the Export page using Cancel Export link as shown below General Information Oat ClEsciptent iO ICAS Registry Number Ml Encipient Category Function F Phanmacopoeial Status Fl Regulatory Status F General Acceptable Daily intake ClAcceptabte Daity Intake for Pediatrics ORevision Date Clinical Data Oa Dlhge Category C Route Of Exposure Or Administration C Duration unit Dosage Form Non Clinical Data Om C Erposure Period Cage Category C Route Of Erposure Or Administration Osystemdrgan Reference E Invitro Data OA F Species F Duration Of Treatment Fl Dosage Form Ci Reference Tipe bea ee lh an Glossary ORetip Clape Odese C Frequency Of Administration C Concussion Comments F RefiD O species Ci Gender C Duration Of Treatment C Salet Tolerability ihdverse Effects UReference Tipe vl Ref ID C Dose C Duration Unit C Conlusion Comments C Study Tipe C Gender Duration Of Treatment Cl Safety Tolerability Adverse Effects M Reterence Tipe CSu Tipe Age Units Dose Units Frequency Of Administration Oiconelusion Comments El Study Type fv Route Of Exposure Or Administrati
74. re will be no color differentiation and the page appears as shown below Clinical Data Show Hide Clinical Columns Ref ID push ians Name Study lype Age Lategory eA Units Gender Benzyl Alcohol Toxicokinetics Benzyl Alcohol Toxicokinetics Unspecified Unspecified Linspecified Unspecified Benzyl Alcohol Acute Toxicity Adolescent Children Benzyl Alcohgl Acute Toxicity When user clicks Ref ID value then the complete reference information appears in a separated tabular format as shown below Search Results Page 54 Eu US PFI User Guide Clinical Data Show Hide Clinical Columns E Benzyl Aleahol Tessicatdnet ics Infant Year Oral Route OF Exposure Or Administration Dae Benzyl Alcohol Toxicokinetics Unspecified Unspecitied Unspecitied Unspecihed Benzyl Alcohol Acute Toxicity Adolescent Children 5 13 Benzyl Aloohal Acute Toxicity REF ID REFERENCE Pisa Fier LJ Jr Baker GL Stegink LD Effect Of Aspartame Loading On Pasma And Erythrocyte Free Amino Acid Concentrations in One Year Ond infants J Nutr 1983 Aug 138151 3 PubMed PMID 6135765 The Reference information tabular format includes complete information about the related Reference ID Reference information Title Author Reference Type and Year as shown above 7 2 2 Excipient Name Based on the search criteria the relevant Excipient Name appears in the Excipient Name column as
75. rgan Safety Tolerability Adverse Effects l i Ungspeoried Unspecified Unspecified 3 Times Day For 2 Days Weeks Neurophysiologic Neuropsycholo No Effect On Cognitive And Beh More More 3 Times Daily Neurophysiologic Neuropsycholo No Effect More 7 2 12 Duration Units Displays duration of the dose in units lineal Data Show Hide Clinical Columns 4 Duration Of Treatment Duration Units Frequency Uf Administration System Urgan satety lolerability Adverse Eifects SS Unspecified Unspecified Unspecited Unspecified 3 Times Day For 2 Gays Neurophysiclegic Neuropsychoelo No Effect On Cognitive And Beh i al 5 re i id Em re 4 3 Times Daily N europhysiclogic Neuropsychola No Effect More 7 2 13 Frequency of Administration This indicates the administration of doses to the test species example 2 doses per day 5 days per week as shown below Search Results Page 60 Eu US PFI User Guide Liinical Dats how Hide Clinical Columns Safety Tolerability Adverse Effects _ oOo O oOoOoOo Unspecited inspecihiied Unspeched Unspecified Unspecified B Times Day For 2 Days Neuroephysiclogic Neuropsychola No Effect On Cognitive And Beh 3 Times Daily Neurophysiologic Neuropsychelo No Effect F P 1 i More 7 2 14 System Organ Indicates on which organ or system the effects were observed Clinical Data how Hide Cl
76. roject Non functional Requirements Software design requirements related to the efficiency reliability portability and usability of the system Also known as supplementary requirement Process A set of activities that produces products and services for customers Process Flow The set of steps or working states in a documented standard process Requirement A requirement describes a condition or capability to which a system must conform either derived directly from user needs or stated in a contract standard specification or other formally imposed document A requirement is a desired feature property or function to be met by the application Scope The established boundary or extent of what must be accomplished during planning This defines what the project will consist of and just as important what the project will not consists of Software Requirements Specifications SRS A project artifact that defines the complete system requirements through use cases and supplementary specifications Glossary Page 105 Eu US PFI User Guide Web based A set of interconnected web pages usually including a homepage generally located on the same server and prepared and maintained as a collection of information by a person group or organization Web based applications are usually accessed with a web browser e g Microsoft Internet Explorer Netscape User interface The programming that controls a display for the user usually o
77. s Weeks Days Non ainical Data Show Hide Non Clinical Columns Dose Concentration Dose Units Route Of Exposure Administration Duration Of Treatment Duration Units Frequency Of Administration System Organ Adverse Effect Unepeciied Plasma Brain Convulsions Continuous No Effect G Kg Day r N Continuous Gm Kg Continuwaus Multi Organ Reduction In Bt gt Weight 2000 4000 Mg Kg 4 Search Results Page 73 Eu US PFI User Guide 7 3 14 Frequency of Administration This indicates the administration of doses to the test species example 2 doses per day 5 days per week as shown below Non Clinical Dala Show Hide Non Clinical Columns Dose Concentration Dose Units Route Of Exposure Administration Duration Of Treatment Duration Units Frequency Of Administration System Organ Unspecified Unspecified apadi Plasma Grain Convulsions Gig Day Continuous No Effect G Kg Day Continuous No Effect a Gm Kg Oral Continuous Multi Organ Reduction In Bc Weight 2000 4009 g kg 7 3 15 System Organ Indicates on which organ or system the effects were observed like Renal Liver Cardiovascular etc Non Clinical Data Show Hide Non Clinical Columns Dose Concentration Dose Units Route Of Exposure Administration E 0 75 1 0 GiKg Oral Unspecified Unspecified Unspecified G Kgi Day Continuous G Ko Day Weeks Continusus Gm Kg Weeks Continuous Multi Organ Reduction In Be Weig
78. s amp Conditions Lier Name Organization Email Address Confinm Email Address Contact j ee Laniin Number j Basic Search Page 20 Eu US PFI User Guide 5 BASIC SEARCH Login to the application with valid user credentials as shown below EuPFi GOSTEP database Eregi Daag T poet nt os Database of safety and toxicity of excipients for paediatrics I m an Existing Eupfi User Login Email 4 Forgot Login Email New User Register Now Why Registration Revision Date 06 25 2012 EUPFI DATABASE END USER LICENSE AGREEMENT e This End User License Agreement shall be governed by the Unite Kingdom laws without giving effect to principles of conflict of laws You hereby consent to the exclusive jurisdiction and venue of the courts sitting in London United Kingdem to resolve any disputes arising under this End User License Agreement This End User License Agreement contains the complete agreement between the parties with respect to the subject matter hereof and supersedes all prior or contemporaneous agreements or understandings whether oral or written You agree that any varying or additional terms contained in any purchase order or other written notification or document issued by you in relation to The ONLINE STEP DATABASE licensed hereunder shall be of no effect The failure or delay of EuPFI to exercise any of its rights under this End User License Agreement or upon any breach of this End lve read
79. s as shown below Clinical Data how Hide Clinical Columns 4 Ret ID Exciplent Name Study lype Benzalkonium Pl Select all i fears i Intraocular mite Chloride Acute Exposure an F Chronic Toxicity Benzalkonium Chloride Immunatoxicity Long Term Unspecified Unepectied intranasal Benzalkonium Immunctoxaty Adults 5 Inhalation Chloride Benzalkonium Acute Exposure Unspecified Unepecified Unepecified Unspecified Intranasal Chloride In the drop downs of all columns all the values that are in the drop downs appears as shown above along with check boxes and user can select deselect the required value Study Type using the checkboxes as shown below When user selects the required checkboxes then only those values appears in the results as shown below Clinical Data Show Hide Clinical Columns amp Ref ID Excipient Name Study Type E Age Category A Gender Route Of Exposure Or Administration __ _ a a m a J Eenzalkonium Select al Unspecified Unspecified Intranasal Chloride Acute Exposure a Chronic Toxicity Immunotoxicity Benzalkonium Inhalation Chloride le Long Term Search Results Page 89 Eu US PFI User Guide Clinical Data Show Hide Clinical Columns E Benzalkonium f Long Ter Adults Unspecified Unspecified i Intranasal Chloride Benzalkonium Immunotoxicity Adults 12 45 Year inhalation Chloride Note As the data columns in all the tabs among the Clinical
80. sent to the exclusive jurtedictian and venue of the courts sitting in Landon United Kingdom bo resale ani diznukes pring under thie Ena Uzer License 4Aqreement F j That End User License Agreement contains the complete agreement between the pares with respect to the subject matter hereof and supersedes ail prior ar COntemporsn ous esgreements or understandings whether oral or writen You gree that any varying or additional terms contained in any purchase order or other written notification or document issued by you in relation to Tre ONLINE STEP DATABASE licensed hereunder shall be of mo effect The failur or delay of ELPFI to exercise any of its nghts under this End User License Agreement or upon any breach of thes End O Ive read the Disclaimer and accepted the Terms amp Conditions Leer Mate Organization Email Address conim Emal Address Contact i CAELUM Number J Session expiration Page 18 Eu US PFI User Guide 4 LOGOUT Inorder to logout of the application user can use Logout link in the right top corner as shown below Please enter minimum of 3 _ characters to populate suggestions Please use Ctrl Mouse click to select multiple values Please use icon to open selection dialog box Progressive search will be based and filtered on the values already You re logged out of Euphi Click here to Login If user desires to login to the application can click
81. the Disclaimer and accepted the Terms amp Conditions Then click Login button application navigates user to Search page as shown below _________________________ Please enter minimum of 3 a Ralat a f characters to populate suggestions Benzalkonium chloride pi ure CH House click to Benzoic acid JBenzylaicohot M select multiple values Please vce icon to open selection dialog box CAS Registry Number e ina a Progressive search will be based i and filtered on the values already i oe A 4 selected in dropdowns 1315 77 3 E 6731 55 8 Synonyms 4s per the Handbook of Excipients Select i vinyl 2 pyrrolidinone polymer 1 2 Benzenedicarboxylic aad dimethyl ester 1 2 Diethyl phthalate Select Adsorbent Antimicrobial preservative Coating agent Confectionery base Basic Search Page 21 Eu US PFI User Guide In the STEP application by default Basic Search page appears wherein user is allowed to select the required data and can view the results Search page provides results based on Excipient Name CAS Registry Number Synonyms and Function 5 1 Search by Excipient Excipients in medicines are ingredients other than the active drug that are essential for their manufacture stability and function Superlatively an excipient is pharmacologically inactive non toxic and does not interact with the active ingredients or other exc
82. tract 7 5 2 Reference ID All references will be given a unique reference ID This will help users to identify the references where two or more studies are discussed in one reference Regulatory Reference Reference When user clicks Ref ID link in the Regulatory References table as shown below the entire information of the reference appears as a tabular separate with the Ref ID Reference Title Author Reference Type and Year information as shown below Search Results Page 85 Eu US PFI User Guide Regulatory Reference Reference AUTHOR REFERENCE TYPE YEAR JECFA Toxicological Evaluation Of Some Food Additives Howding Anticaking Agents Antmicrobiss Antoxdanis Emulsifers And Thickening Agents WHO Food Addaives Series 5 mi 1974 7 6 Reviews This includes the references to the general safety and toxicological reviews and specific reviews Ex IPCS IARC monograph reviews ASTDR reviews etc Reviews Reference 7 6 1 References Indicates the source from which the information is extracted Bibliographic source of the study report or publication will be provided The references would be linked to their original source through DOI The users who need the details of the study will be able to access the full text if available with their subscription or will be able to access the abstract 7 6 2 Reference ID All references will be given a unique reference ID This will h
83. tributes 1 Search by Excipients e Study Type e Species e Age Category Advanced Search Page 42 Eu US PFI User Guide e Route of Exposure Administration e Function 2 Search by Effect v Organ System 6 2 1 Search by Excipient Search by Excipients includes all the data related to the excipient related to the Study Types Species Age and Route of Exposure Administration Based on the data selected under the above categories then relevant Excipients and its related data appears in the search results 6 2 1 1 Study Type Study Type helps in providing the nature of investigations like Acute Toxicity Experimental Animal Study Eye Irritation Ocular Toxicity etc Non Clinical Data Seanch For Excipients study Type Species Age Category Route of Exposure Administration Function Advanced Search Chronic toxicity Experimental animal study Eye irritation Immunotoxicity Imunotoxicity Select Dogs Mice Rabbit Rabit Select Adult Adults Juvenille Juvinilhe Select Inhalation Intravenous Intravenous infusion Oral Film forming agent Ointment base Sweetening agent Tablet and capsule lubricant antimicrobial agent Page 43 6 2 1 2 Species Eu US PFI User Guide Species indicates the animal species used in the experiment Example rabbit rat sheep cat cattle dog gerbil guinea pig hamster monkey mouse pig and other Non Clinical Data
84. ts Function Polyethylene giycal lPolyvinylpyrrolidene Potassium metabisulphite paraben 4 jaipha hydroxytoluene benzylic alcohol thydroxymethylbenzene iphenmethylal iphenylcarbinol h Select Adsorbent Antimicrobial preservative Coating agent Confectionery base Please enter minimum of 3 characters to populate suggestions Please use Ctrl Mouse click to select multiple values Please use icon to open selection dialog box Progressive search will be based and filtered on the values already selected in dropdowns User can select CAS Registry Number and Synonyms also along with the selected Excipient Name to retrieve the results as shown below Search by Excipient Excipient Name CAS Registry Number Synonyms AS per the Handbook of Excipients Basic Search Genzy alcohol Propylene glycol Polyethylene glycol Polyvinylpyrralidone Potassium metabiculphite alpha hydroxytoluene benzylic alcoho hydroxymethylbenzene phenmethylol phenyicarbinal Adsorbent Antimicrobial preservative Coating agent Confectionery base Please enter minimum of 3 characters to populate suggestions Please use CL Meuse chick to select multipla values Please use icon bo open selection dialog box Progressive search will be based and filtered on the values already selected in dropdowns Page 27
85. ttps juwan eupfi org Mh 9 Esr Resuts Rey i Fie Edt View Favortes Tools Help Lins moea Search by Excipient Euopean Paediatric Formulation Initiatie Excipient Name European Paediatric Formulation initiative Please enter minimum of 3 n characters to populate suggeshons Please use Ctrl Mouse click to selact multiple values Welcome to EuPFI Please use icon to open ie fection dialog box CAS Registry Number About ls ot iit Ful CuPEL Worksireanns Progressive search will be based and filtered on the values already selected in dropdowns Session expiration Page 17 Eu US PFI User Guide 3 SESSION EXPIRATION If the user keeps the application idle for more than 30minutes then the session automatically gets expired and displays the below message EU PF j sur datakase feroreet Specerc om eto in eat Database of safety and toxicity of excipients for paediatrics Session Expired click Here to login Developed by GVKYBIO GOSTAR G BIOM To login to the application click Here link which automatically opens the application s login page I m an Existing Euph User Fong Login E rmmadl New User Register Now Why Registration Revision Dale 06 25 2012 EVUPFI DATABASE END USER LICENSE AGREEMENT This End User License Agreement shall be governed by the United Kangdom laws without giving effect to poncples of conflict of laws You hereby con
86. ty and Toxicity of Excipients for Paediatric STEP Database holds all the animal toxicity and human health data regulatory information and toxicological reviews of excipients STEP acts as repository for all the scientific communities to share the data for better understanding and paediatric drug development 1 2 Scope STEP database is intended to provide the data availability for the paediatric formulation development by the implementation of freely accessible online source which will provide easy access to authoritative comprehensive database of adverse effects of excipients for paediatrics from a key resource Its main compass is to provide all the regulatory information and toxicological reviews of excipients STEP accomplishes a high level scientific literature review of the pharmacology toxicology and safety data of a prioritized group of excipients likely to be used in paediatric formulations Introduction Page 4 Eu US PFI User Guide 1 3 Purpose STEP main rationale is to afford the public access of an evidence database of safety and toxicity of excipients for the pharmaceutical industry academics clinicians and regulators to make informed decisions This also enhances the prospects of identifying potential safety issues at earlier stages of the development process when excipients are being screened and selected STEP also establishes a fine relationship between exposure and evidence of clinically significant toxicity i
87. ubricant Function tablet binder tablet disintegrant tablet disintegrant Search by Effect Organ System Cellular system Central Nervous System ba Reset asic search Advanced Search Page 45 Eu US PFI User Guide 6 2 1 5 Function Functional Data helps to provide the information which is neither Clinical nor Preclinical data It facilitates user to access the data based on the function values as shown below Non Clinical Data Search For Excipients Select Acute toxicity Study Type Acute toxicity Carcinogenicity Chronic toxicity Species Select Adult Age Category Adults Juvenille Juvinille Select Inhalation Route of Exposure Administration Intravenous Intravenous infusion Oral Select Adsorbent l Antimicrobial preservative Coating agent Confectionery base 6 2 2 Search by Effect Effect is any undesired action or effect of an excipient User can view the search results based on the effect 6 2 2 1 Organ System Indicates on which organ or system the effects are observed Example Kidney Brian Cellular System Renal Liver Cardiovascular etc Seanch by Effect Select Organ System Cellular system Central Nervous System suem M basic search Advanced Search Page 46 Eu US PFI User Guide When user provides any search criteria in the Non Clinical Data page and clicks Submit button as shown below N
88. zyl alcohol CAS Registry Number 100 5 1 6 Excipient Catagory Function Pharmacopoeial Status Regulatory Status Synonyms Acceptable Dally Intake Revision Date how Hide Clinical Columns El Ref ID 1 Excipient Name Study Type Age Category Age G Route Of Exposure Or Administration Dose ze Select to Export General Information Call excipient iD Ci cas Registry Number Excipient Nama C Excipient CatagoriFunction A Fharmacopoaial Status Regulatory Status Synonyms a General Acceptable Daily Intake Acceptable Daily intake for Padiatrics l oO Revision Date Clinical Data Non Clinical Data Invitro Data Reference Export to Excel Export to PDF Cancel Export In this page all the information can be selected based on user requirements using the check boxes and the data in the corresponding categories is provided in collapsed mode and user can click symbol besides the name of the category to view the expanded mode as shown below Export Page 95 Eu US PFI User Guide Select to Export General Information Dal excipient io ices Registy Number Enciplent Name Clencigient CategoniFunction Pharmacopoeia Status O Reguiatory Status Oi sinonyms General Acceptable Daily Intake Cl Acceptable Daily Intake for Pediatrics Revision Date Can Orern Engipient Nam C Study Type Age Category Cige Ii C Gender CiRoute Of Exposure Or Ad

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