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平成23年度経済産業省委託事業 平成23年度戦略的技術開発委託費

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400. 1 p34 40 1996 2 Paul D et al Cell 30 215 224 1982 3 Chang S C N et al J Biomed Mater Res 55 503 511 2001 4 Implants for surgery Quantification of sulfated glycosaminoglycans sGAG for evaluation of chondrogenesis ISO TC 150 SC7 draft 5 Villar Suarez V et al J Biomed Biotech 4 364 373 2005 6 p85 87 2002 7 Schnabel M Et Al Osteoarthritis Cartilage 10 62 70 2002 8 Yokoi M et al J Tissue Eng Regen Med 2011 9 11 p 2011 10 Diaz Romero J et al J Cell Physiol 202 731 742 2005 11 Kawasaki K et al J Cell Physiol 179 142 8 1999 12 Dey P et al Connect Tissue Res 28 317 324 1992 13 Farndale R W et al Connect Tissue Res 9 247 248 1982 40 14 Frandale R W et al Biochem Biophys Acta 883 173 177 1986 15 Akiyama H Mod Rheumatol 18 213 219 2008 16 Rapko S et al Tissue Engineering Part C 16 18367 1375 2010 17 Morita Y et al Biomed Mater Eng 12 291 8 2002 18 Morita Y et al J Biomech 39 103 9 2006 41
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426. 20 Plasus Specline LTB 21 K E Grund et al Endoscope Surgery 2 1994 42 22 G Fridman G Friedman A Gutsol A B Shekhter V N Vasilets and A Fridman Plasma Process Polym 5 503 2008 23 M Laroussi IEEE Trans Plasma Sci 37 714 2009 24 M G Kong G Kroesen G Morfill T Nosenko T Shimizu J van Dijk and J L Zimmermann New J Phys 11 115012 2009 25 A Fridman et al Plasma Processes and Polymers Vol 7 No 3 4 2010 194 26 Y Sakiyama D B Graves J Jarrige and M Laroussi Appl Phys Lett 96 041501 2010 27 K D Weltmann E Kindel T von Woedtke M Hahnel M Stieber and R Brandenburg Pure Appl Chem 82 1223 2010 28 H Sakakita and Y Ikehara Plasma and Fusion Research 5 2117 2010 1 4 29 J Ehlbeck U Schnabel M Polak J Winter Th Von Woedtke R Brandenburg T von dem Hagen and K D Weltmann J Phys D Appl Phys 44 013002 2011 30 H W Lee G Y Park Y S Seo Y H Im S B Shim and H J Lee J Phys D Appl Phys 44 053001 2011 31 W Kim K C Woo G C Kim and K T Kim J Phys D Appl Phys 44 013001 2011 we wae wa 287 V 2 2007
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531. FDA RT PCR IVDMIA PGx DNA DNA OECD GLP DNA SRL
532. 2 3 2 3 2 4 3 QOL
533. 80C validation 3 2 5 4 5mm DNA DNA MicroRNA
534. ALT 38 38 U L 2 20 6 M SDTM http www fda gov cder regulatory ersr Studydata v1 1 pdf 197 SDTM 2 2 5 6 AMARENA USUBJID MITESTC MISTA MIREASN MIGRPI MISE D D MITEST MIORRES T D D Q DY 1 LIVER 1 1 2 LIVER 1 2 3 LIVER 1 3 4 LIVER 1 4 5 LIVER 1 5 6 LIVER 2 6 7 LIVER 2 7 8 LIVER 2 8 9 LIVER 2 9 10 LIVER 2 10 198 DDDDD 1 This guidance has been prepared by the Center for Drug Evaluation and Research CDER the National Center for Toxicological Research NCTR and the Center for Biologics Evaluation and Research CBER in cooperation with the Center for Devices and Radiological Health CDRH at the Food and Drug Administration For the purposes of this guidance the term drug or drug product includes human drug and biological products Paperwork Reduction Act Public Burden Statement According to the Paperwork Reduction Act of 1995 a collection of information should display a valid OMB control number The valid OMB contr
535. R ISO TC150 TC198 R 2 13 2 WG FDA
536. RNA mRNA 3 mRNA mRNA 180 5
537. 3 CAD 100 CAD CAD 2009 10 FDA CAD
538. 4 4 4 WG 1 BA A 24 1 18 2 4 3 WCB AR 81 4 1 3 2 3 PPT 5
539. 90 0 lt 90 6 E 1 2 2 E E iE o0 go Pa 1 FE E cos Pal E E sin Pal 3 51 tan6 E 4 E complex modulus 6 i G2 1 E dynamic modulus storage modulus E loss modulus tan6 loss tangent tan6
540. KineretTM Labonnet Ltd Agilent 4 Agilent Corporation Isohelix 1 Cell Projects Ltd Affymetrix 4 Affymetrix Inc 210 3 5 DNA 3 5 1 205 DNA Cy3 DNA sesamin enterodiol enterolactone matairesinol pinoresinol lariciresinol isolariciresinol secoisolariciresinol 3 5 2 3 5 2 1 150 8 cDNA
541. medical robot degree of autonomy DoA DoA DoA DoA WG WG JWG 6 6 1 1 WG 1 24 2 14 17 00 19 05 2
542. 1 2
543. 5 2 oo go 6 1 6 0 E
544. Amersham Agilent DNA SPIDIA SPIDIA 2008 2012 4 1 300 7 8 SPIDIA RNA PAXgene Tissue System 30 219 322
545. JIS Z 2245 ISO 6475 Implants for surgery Metal bone screws with asymmetrical thread and spherical under surface Mechanical requirements and test methods ISO 6892 Metallic materials Tensile testing at ambient temperature ISO 9585 Implants for surgery Determination of bending strength and stiffness of bone plates ISO 7207 2 Implants for surgery Components for partial and total knee joint prostheses Part 2 Articulating surfaces made of metal ceramic and plastics materials ISO 21535 Non active surgical implants Joint replacement implants Specific requirements for hip joint replacement implants ISO 7206 1 8 Implants for surgery Partial and total hip joint prostheses ISO 14242 1 7 Implants for surgery Wear of total hip joint prostheses ISO 5838 1 Implants for surgery Skeletal pins and wires Part 1 Material and mechanical requirements ISO 8827 Implants for surgery Staples with parallel legs for orthopaedic use General requirements ISO 6507 1 4 Metallic materials Vickers hardness test ISO 14243 1 Implants for surgery Wear of total knee joint prostheses Part 1 Loading and displacement parameters for wear testing machines with load control and corresponding environmental conditions for test ISO 14243 2 Implants for surgery Wear of total knee joint prostheses Part 2 Methods of measurement ISO 14243 3 Implants for surgery
546. WG WG WG WG W 1 2 G 1 G 2 G 3 G 4 G G 5 G 6 G G 7 G
547. Bl A 2 2S 7 2 8C 4
548. ER GH 4 1 2 3 4 iBOT 5 6 BRE 7 8 5 iBOT FDA iBOT FDA TAZA
549. time to event 95 5 time to event
550. DNA 3 DNA DNA DNA 13 2 1 1 PSS 8 2 1 2 DNA chip 3 2 1 3 DNA 1
551. JMAC DNA 4 2010 5 2010 5 1 2 22 5 2 2 22 5 3 5 4 2 22 5 5 IEC 62304 2006 5 2010 2 3
552. SPIDIA 3 1300 2 7 AR 2 8CT 8 PAXgene PAXgene
553. 11 Hh 3 2 1 3
554. 2007 120 2010 Mason Manzotti 2 1 2 Smith 2010 5 iPS 1 10 2008 1 2 BioInformant 2008 9 10 2013 14 5 2008 30 15 9
555. DNA DNA WG 1 MAQC 1
556. DNA DNA 2007 19 5 20 DNA 2 2 DNA 18 19 21 22 23 22 DNA DNA DNA
557. IEC62304 1 CAD CAD A BRIEC B IEC62304 2 IEC62304 RU JIS Q 13485 2 i CAD
558. MTT 1 4 Ik CHS LAL 19
559. R WG WG 24 23 W G 1 1 23 12 9 13 00 17 00 2 RP SHE 2 1 3 BA b gt HE Fk Mt NE i 4
560. 2007 2010 2007 2010 148 WG WG WG HH WG WG WG 1 WG WG 19 ISO MAQC DNA
561. RNase RNase HOT RNA RNA RNA RNase RNase RNA HAO RNA RNase RNA RNA RNA
562. Sx105 10 10 0 01 mg A B 2 A B E 2 b 100 5 15 mg
563. XPS JIS T 0302 0 V vs SCE 10 pA cm Ti JIS T 7401 2 Ti 6AL4V JIS T 7401 4 Ti 15Zr 4Nb 4Ta Co 28Cr 6Mo JIS T 7402 1 JIS T 7402 2 Zr 2 SNb ASTM F2384 JIS T 7403 1 10 nuA cm2 Ei pH 1 3 ISO 16428 ISO 16429 0 9 NaCl pH S 6 pH 5 5 MEM pH 7 5 PBS pH 7 5 1 8 NaCl 2 7 NaCl 3 6 NaCl 4 5 Na
564. gt degree of autonomy 4 2008 295
565. 2 PSS 3 2007 4 2010 4 1 2010 4 2 2010 5 WG 5 1 2010 WG 22 DNA WG 23 3 14 28 5 2 WC WG 6 DNA 6 1 DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007 6 2 DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007 6 3 SPIDIA Newsletter 10 2011 October 2011 6 4 SPIDIA Newsletter 10 2011 October 2011 6 5 The MicroArray Quality Control MAQC II study of common practices for the development and validation of microarray based predictive models Nat Biotechnol 2010 Aug 28 8 827 38 5
566. 5 23
567. 8 http arrayconsortium tgen org np2 public qualitycontrol jsp 9 Dumur C I et al 2004 Evaluation of quality control criteria for microarray gene expression analysis Clinical Chemistry 50 11 1994 2002 10 Imbeaud S Graudens E Boulanger V Barlet X Zaborski P Eveno E Mueller O Schroeder A and Auffray C 2005 Towards standardization of RNA quality assessment using user independent classifiers of microcapillary electrophoresis traces Nucleic Acids Research 33 6 e56 External RNA Controls Consortium 2005 The External RNA Controls Consortium a progress report Nature Methods 2 731 734 http edkb fda gov MAQC 1 Shi L Tong W Su Z Han T Han J Puri R K Fang H Branham W S Chen J J Xu Z Harris S C Hong H Xie Q Perkins R G and Fuscoe J C 2005 Microarray scanner calibration curves characteristics and implications BMC Bioinformatics 6 Suppl 2 S11 4 Simon R Development and evaluation of therapeutically relevant predictive classifiers using gene expression profiling 2006 J Natl Cancer Inst 98 17 1169 71 5 Simon R 2006 A checklist for evaluating reports of expression profiling for treatment selection Clin Adv Hematol Oncol 4 3 219 24 6 Dobbin KK Simon RM 2007 Sample size planning for developing classifiers using high dimensional DNA microarray data Biostatistics 8 1 101 17 7 Varma S Simon R 2006 Bias in error estimation when using c
568. 86 10 25 1999 25 85 3 6 Artificial Neural Network 2005 1 5 1 5 DNA DNA 1mm 2mm
569. DNA DNA DNA ISO DIS16578 GMP QMS ISO18485 219 2 GMP QMS ISO13485 3 3 1 DNA 1 2 3 5 6 7 3 2 DNA
570. N oO Total smooth area of reparative cartilage compared to the whole area of the cartilage defect Average thickness of reparative cartilage compared with that of surround ing cartilage 70 Table 2 International Cartilage Repair Society Il Visual Histological Assessment Scale Histological Parameter Tissue morphology polarized light Matrix staining metachromasia Cell morphology Chondrocyte clustering Surface architecture Basal integration Tidemark formation Subchondral bone abnormalities marrow fibrosis 9 Inflammation 10 Abnormal calcification ossification I 1 Vascularization in repair tissue 12 Surface superficial assessment 13 Midzone deep zone assessment 14 Overall assessment CNR NR w MN Note From Mainil Varlet et al ICRS I Score Visual Analog Scale Score 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 0 100 TABLE ICRS Visual Histological Assessment Scale Surface Smooth continuous Discontinuities irregularities Matrix Hyaline Mixture hyaline fibrocartilage Fibrocartilage Fibrous tissue Cell distribution Columnar Mixed columnar clusters Clusters Individual cells disorganized Cell population viability Predominantly viable Partially viable lt 10 viable Subchondral Bone Normal Increased remodeling Bone necrosis granulation tissue Detached fracture callus at base Cartilage mi
571. R 22 12 15 1215 1 Implants for surgery Quantification of sulphated glycosaminoglycans sGAG for evaluation of chondrogenesis ISO TC 150 SC7 WG 33 2 2 1 WG
572. Ti 15Zr 4Nb 4Ta 8 0x10 1 K 7 95x10 Co Cr Mo 8 34x103 Ti 4 51x103 Ti 6Al 4V 4 42x103 Ti 15Zr 4Nb 4Ta 5 00x103 kg m 0 48x103 Co Cr Mo 0 45Sx103 Ti Ti 6Al 4V 0 52x103 Ti 15Zr 4Nb 4Ta 0 47x10 J kg K 1 NDIS 3425 2008 109 H H 1 H 1 Cr Mo N 20 Tj
573. Wear of total knee joint prostheses Part 3 Loading and displacement parameters for wear testing machines with displacement control and corresponding environmental conditions for test ISO 14879 1 Implants for surgery Total knee joint prostheses Part 1 Determination of endurance properties of knee tibial trays ASTM E8 E8M Standard Test Methods for Tension Testing of Metallic Materials ASTM F382 Standard Specification and Test Method for Metallic Bone Plates ASTM F384 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F2180 Standard Specification for Metallic Implantable Strands and Cables ASTM F366 Standard Specification for Fixation Pins and Wires ASTM E8 E8M Standard Test Methods for Tension Testing of Metallic Materials ASTM F1800 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components 125 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 of Total Knee Joint Replacements ASTM F1223 Standard Test Method for Determination of Total Knee Replacement Constraint ASTM F1715 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices ASTM F2025 Standard Practice for
574. ee shale cialis ee 3 RR 4 5 DNA 6 7 8 1 1 8 WG WG 2
575. 1 000 22 2 gt WG
576. 188 FDA 21 CFR 58 CMS CLTA CLIA CLIA V
577. 21 4 1 415 14 2
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580. Cell processing engineering for ex vivo expansion of hematopoietic cells a review J Biosci Bioeng 99 189 196 2005 M Kino oka M Taya Recent developments in processing systems for cell and tissue cultures toward therapeutic application J Biosci Bioeng 108 267 276 2009 126 133 2007 BA TAR 29 131 134 2009 DORR IAT h 3 16 2010 a A 25 32 2010 MF CPC 274 280 2010 CPC ATL 214 224 2010 C
581. DNA DNA 2009 FDA 2009 i IVDMIA DNA MammaPrint ME Agendia 3 m oF 710 DNA DN A DNA 2007 6 15
582. gt WG 20 ISO JIS 21 EMC
583. 1 6 8 3 BH KA BR 4 1 2 23 3 23 2 WG R 4 R 5 3 6 Field of Regenerative Medicine Cell Sheets R amp D Guideline for the Desing of a Pass Box with Decontamination 2010 7 Field of Regenerative Medicine Cell Sheets R amp D Guideline for the Desing of an Aseptic Transfer Interface 2011 5 1 2 WG R
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586. 21 http www meti go jp policy mono_info_service service iryou_fukushi downloadfiles 200 806 3 pdf 22 http www meti go jp policy mono_info_service service iryou_fukushi downloadfiles 2008 06 4 pdf 23 AMIR ROL PALVUVATLARATESIY http www meti go jp policy mono_info_service service iryou_fukushi downloadfiles 2008 06 5 pdf 24 http www meti go jp policy mono_info_service service iryou_fukushi downloadfiles 2010 11 10 pdf 275 3 23 2 WG 3 1 1 WG 1 24 1 26 16 00 18 00 2 2 LABS 3 ER GH BR TR A
587. 24 1 26 17 00 19 20 234 2 4 1 3 WG R 4 2 2011 R 4 3 4 4 23 CAD WG 4 1 3 RAL BA 4 3 e 4 2 2 23 FE CAD WG A ss1 2
588. 33 110 3096 m 7 25 28 m 1648 53 30 K OOA OlS te 8 4 27 30
589. 4 2008 2008 2010 2011 123 2 3 4 5 6 7 8 9 10 dD 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 JIS G 4303 JIS G 4305 JIS G 4308 JIS G 4309 JIS G 4314 JIS G 4315 JIS H 4600 JIS H 4650 JIS H 4670 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought stainless steel ISO 5832 2 Implants for surgery Metallic materials Part 2 Unalloyed titanium ISO 5832 3 Implants for surgery M
590. Clinical trial designs for predictive marker validation in cancer treatment trials J Clin Oncol 2005 23 9 2020 2027 2 Class II Special Controls Guidance Document Instrumentation for Clinical Multiplex Test Systems 3 Class II Special Controls Guidance Document Instrumentation for Clinical Multiplex Test Systems 4 Five years is used in this section as an example of a minimum time point It is possible that some studies may have endpoints exceeding five years 5 The use of banked leftover specimens is discussed in FDA s guidance Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 175 6 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 3 42 FDA 2 2 24 1 12 FDA II DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007
591. DNA c cDNA DNA 65 FLA 8000 FujiFilm EF 28 log 212 Sesamin Enteradiol Bw ha Matairesinol Sesamin Enterolactone O Enterolactone Matairesinol OH Pinoresinol Lariciresinol O Pinoresinol Lariciresinol HO lsolariciresinol Secoisolariciresinol Isolariciresinol Secoisolariciresinol 3 DNA 150 2 Tzs
592. LBNAM XYZ 2 LBLOC 3 SPECIES 4 STRAIN Sprague Dawley 5 DESIGN 6 TRMSAC 1 6 7 GLPTYP GLP FDA 8 QARPT QA 9 DURDOS 6 10 Sprague Dawley 6 STTITL 11 ALTSTDID ID ID 123456 12 SENDVER SEND 2 3 13 STDTC 2001 5 1 14 ENDTC 2001 7 1 15 2 ARAL USUBJI ARMC SCTESTC SCORRE SCSTRES D D D S SCTEST C SCSEQ 1 1 SEX Male 1 2 1 SEX Male 2 3 1 SEX Male 3 4 1 SEX Male 4 5 1 SEX Male 5 6 2 SEX Male 6 7 2 SEX Male 7 8 2 SEX Male 8 9 2 SEX Male 9 10 2 SEX Male 10 3 HAE ARMCD GCTESTCD GSCORRES GCTEST GCSRESC GCSEQ 1 GRPNAM Low dose HA 1 1 CTLGRPDFL N N 2 2 GRPNAM Control 3 2 CTLGRPDFL Y Y 4 195 4 ABBE USUBJID ARMCD EXTRT EXTRTV EXDOSE EXDOSU EXDOSFRQ EXDOSFRM EXDOSTOT EXROUTE EXDUR EXGRPID EXSEQ STDY ENDY 1 1 X Labrafil 10 mg kg
593. 0 1 10 Hz JIS T 0309 S N H 2 10 107 oc S N 10 107 100 10 110 Co 28Cr 6Mo JIS T 7402 2 1400 Mus AZ L TiS JIS T 7401 2 JIS T 7401 4 00 1200 Z 1000 800 3 600 K 400k O O Ti 15Zr 4Nb 4Ta og A Ti 6AL4V 105 106 1 1 1 1 S 1 1 1 1 1 1 0 0 103 10 10 108 107 108 103 104 105 10 107 108 H 2 111 WESI
594. 1 1 10 0 P6D 1 1 1 6 2 1 X Labrafil 10 mg kg 1 1 10 P6D 1 2 1 6 3 1 X Labrafil 10 mg kg 1 1 10 0 P6D 1 3 1 6 4 1 X Labrafil 10 mg kg 1 1 10 0 P6D 1 4 1 6 5 1 X Labrafil 10 mg kg 1 1 10 0 P6D 1 5 1 6 6 2 BAZ Labrafil 10 mg kg 1 1 10 P6D 2 6 1 6 7 2 B H Labrafil 10 mg kg 1 1 0 P6D 2 7 1 6 8 2 BR HZ Labrafil 10 mg kg 1 1 0 P6D 2 8 1 6 9 2 BR HZ Labrafil 10 m kg 1 1 0 P6D 2 9 6 10 2 BR WZ Labrafil 10 m kg 1 1 0 P6D 2 10 6 SDTM http www_fda govicder regulatory ersv Studydata v1 1 pdf 196 SDIM 225 5 aK eH USUB CPTES CPST CPSTR CPSP CPC CPSC CPTE CPSTR CPOR CPORR CPGR CPS DY JID TCD ESN ESU EC AT AT ST ESC RES ESU PID EQ 1 MONO 0 48 10E 9 HEM HER 0 484 0 48 10E 9 1 1 6 4 L 4 L 2 MONO 0 41 10E 9 HEM ER 0 418 0 41 10E 9 1 2 6 8 L 8 L 3 MONO 0 42 10E 9 HEM HER 0 429 0 42 10E 9 1 3 6
595. 100 vol96B B Tp cv B 2 T 30 60 C a p cw B o B Ti B 10 50 vol Nb 9 Ta HTi AB GAIL Ti 15Zr 4Nb 4Ta Ti 6Al 4V T 3 b Ti F 2 Ti F 6 a Ty Ti 15Zr 4Nb 4Ta Ti 6Al
596. 3 CADx CADx 2 CADx 2 2 CADx CADx CADx
597. 58 59 60 61 62 63 64 65 66 67 68 69 70 71 ASTM F648 Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants ASTM F799 Standard Specification for Cobalt 28Chromium 6Molybdenum Alloy Forgings for Surgical Implants UNS R31537 R31538 R31539 ASTM F1091 Standard Specification for Wrought Cobalt 20Chromium 15tungsten 10Nickel Alloy Surgical Fixation Wire UNS R30605 ASTM F1314 Standard Specification for Wrought Nitrogen Strengthened 22Chromium 13Nickel 5Manganese 2 5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants UNS S20910 ASTM F1472 Standard Specification for Wrought Titantum 6Aluminum 4 Vanadium Alloy for Surgical Implant Applications UNS R56400 ASTM F1350 Standard Specification for Wrought 18Chromium 14Nickel 2 5 Molybdenum Stainless Steel Surgical Fixation Wire UNS S31673 ASTM F1537 Specification for Wrought Cobalt 28Chromium 6Molybdenum Alloys for Surgical Implants UNS R31537 UNS R31538 and UNS R31539 ASTM F2083 Standard Specification for Total Knee Prosthesis JIS Z 2241 JIS G 0577 TS T 0013 JIS Z 2244
598. 75 survival if initially grafted surface 50 survival if initially grafted surface 25 survival if initially grafted surface 0 survival if initially grafted surface ll Integration Complete integration with surrounding cartilage Demarcation border lt 1 mm 75 integrated 25 with notable border gt mm 50 integrated 50 with notable border gt mm 0 25 integrated Ill Appearance Intact smooth surface Fibrillated surface Small scattered fissures and cracks Small and large fissures Complete degeneration of graft area O NWRO NW Overall assessment and score Grade Normal 12 points Grade 2 Nearly normal 8 11 points Grade 3 Abnormal 4 7 points Grade 4 Severely abnormal 0 3 points Table 3 Cartilage Defect Description Chondral Defects Grade 0 Normal Grade Superficial lesions Grade IA Soft indentation Grade IB Superficial fissures and cracks Grade 2 Cartilage lesions lt 50 of cartilage depth Table 2 International Cartilage Repair Society II Visual Grade 3 Cartilage defects gt 50 of cartilage depth Histological Assessment Scale Grade 3A Not extending down to calcified cartilage E Grade 3B Down to calcified cartilage layer Visual Analog Grade 3C Down to but not through subchondral bone Histological Parameter Scale Score Grade 3D Down to subchondral bone with cartilage a blisters 1 Tissue morphology polarized light 0100 Grade 4 Defects penetra
599. 9 L 9 L 4 MONO 0 44 10E 9 HEM HER 0 447 0 44 10E 9 1 4 6 7 L 7 L 5 MONO 0 47 10E 9 HEM 0 471 0 47 10E 9 1 5 6 1 L 1 L 6 MONO 0 44 10E 9 HEM HER 0 441 0 44 10E 9 2 6 6 1 L 1 L 7 MONO 0 40 10E 9 HEM HER 0 407 0 40 10E 9 2 7 6 7 L 7 L 8 MONO 0 44 10E 9 HEM HER 0 448 0 44 10E 9 2 8 6 8 L 8 L 9 MONO 0 40 10E 9 HEM HER 0 408 0 40 10E 9 2 9 6 8 L 8 L 10 MONO 0 41 10E 9 HEM BER 0 418 0 41 10E 9 2 10 6 8 L 8 L 1 ALT 57 U L CHE ALT 57 57 U L 11 6 M 2 ALT 44 U L CHE ALT 44 44 U L 1 12 6 M 3 ALT 42 U L CHE ALT 42 42 U L 1 13 6 M 4 ALT 39 U L CHE ALT 39 39 U L 1 14 6 M 5 ALT 45 U L CHE ALT 45 45 U L 15 6 M 6 ALT 39 U L CHE ALT 39 39 U L 2 16 6 M 7 ALT 40 U L CHE ALT 40 40 U L 2 17 6 M 8 ALT 40 U L CHE ALT 40 40 U L 2 18 6 M 9 ALT 39 U L CHE ALT 39 39 U L 2 19 6 M 10 ALT 38 U L CHE
600. 9 Xu Q Hamada T Kiyama R Sakuma Y and Wada Kiyama Y 2008 Site specific regulation of gene expression by estrogen in the hypothalamus of adult female rats Neurosci Letts 436 35 39 10 Zhu Y Ogaeri O Suzuki J i Dong S Aoyagi T Mizuki K Takasugi M Isobe S i and Kiyama R 2011 Application of Fluolid Orange labeled probes for DNA microarray and immunological assays Biotechnol Letts 33 1759 1766 11 Dong S Furutani Y Suto Y Furutani M Zhu Y Yoneyama M Kato T Itabe H Nishikawa T Tomimatsu H Tanaka T Kasanuki H Masaki T Kiyama R and Matsuoka M 2012 Estrogen like activity and dual roles in cell signaling of an Agaricus blazei Murrill mycelia dikaryon extract Microbiol Res 167 231 237 214 4 DNA 2011 R 1 1 1 DNA DNA DNA DNA
601. J Turpaz Y Afshari CA Hamadeh HK Damore MA Boedigheimer M Blomme E Ciurlionis R Waring JF Fuscoe JC Paules R Tucker CJ Fare T Coffey EM He Y Collins PJ Jarnagin K Fujimoto S Ganter B Kiser G Kaysser Kranich T Sina J and Sistare FD 2005 Use of a mixed tissue RNA design for performance assessments on multiple microarray formats Nucleic Acids Res 33 e187 25 Reid LH et al 2006 Proficiency testing program for microarray facilities in preparation http www expressionanalysis com proficiency_test html 26 Shi L Reid LH et al 2006 MicroArray Quality Control MAQC Project A comprehensive survey demonstrates concordant results between gene expression technology platforms Nat Biotechnol 24 9 1151 1161 27 ICH guidance E3 Structure and Content of Clinical Study Reports 28 See http www fda gov oc datacouncil 29 The SDTM can be obtained from the CDISC Web site at http www cdisc org models sds v3 1 index html SDTM Implementation Guides The Study Data Tabulation Model Implementation Guide SDTM IG for clinical study data can be obtained from the CDISC web site at http www cdisc org models sds v3 1 index html The Study Data Specification for submitting SDTM datasets to CDER can be obtained at http www fda gov cder regulatory ersr Studydata v1 1 pdf 30 More information can be found at FDA Data Standards Council Web site http www fda gov oc datacouncil The Standard fo
602. RGj gt CPE FE TEM nm Rp CPB L1 0 V vs SCE KRp 7 Rp CPEB 12 Rp 0 9 NaCl 0 9 NaCl B 113 0 V vs SCE 7 Rs CPE 0
603. adjacent cartilage 2 eee _ 50 100 per cent of normal cartilage 1 eee 0 50 per cent of normal cartilage 0 From Pineda et al Bonding to the adjacent pati Bonded at both ends of graft 2 Bonded at one end or partially at both ends 1 Not bonded 0 Freedom from cellular changes of degeneration Hypocellularity Normal cellularity 3 Slight hypocellularity 2 Moderate hypocellularity 1 Severe hypocellularity 0 Chondrocyte clustering No clusters 2 lt 25 per cent of the cells 1 25 100 per cent of the cells 0 Freedom from degenerative changes in adjacent cartilage Normal cellularity no clusters normal staining 3 Normal cellularity mild clusters moderate staining 2 Mild or moderate hypocellularity slight staining 1 Severe hypocellularity poor or no staining 0 MANKIN et al TABLE I HISTOLOGICAL HISTOCHEMICAL GRADING Grade Grade I Structure III Safranin O staining 5 a Normal 0 a Nor f b Surface irregularities 1 b Slight reduction 2 c Pannus and surface irregularities 2 c Moderate reduction 4 d Clefts to transitional zone 3 d Severe reduction A e Clefts to radial zone 4 e No dye noted f Clefts to calcified zone 5 g Complete disorganization 6 II Cells 5 a Normal 4 b Diffuse hypercellularity 1 IV Tidemark integrity c Cloning 2 a Intact 5 b Crossed by blood vessels 1 d Hypocellularity Serial histological sections cut at five micrometers and stained with hematoxylin and on and safr
604. if want to compare results to literature e Histomorphometry repair tissue thickness total soft tissue volume above bone for human biopsies where bone occupies 250 of section width or above the projected tidemark for animal sections with flanking cartilage Analysis for area glycosamino glycan collagen type I and collagen type II staining Optional line measurements for defect width and cartilage subchondral bone integration animal e PLM for collagen fibril orientation semiquantitative scoring system e Optional immunostain for specific markers of interest Electron microscopy for cell morphology and collagen fibril diameter orientation Subchondral bone structure and repair bone volume fraction Subchondral cyst presence absence animal repair Assess synovial histology As our understanding of cartilage repair and chondrocyte biology improves these recommendations may have to be modified 67 Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair International Cartilage Repair Society Recommendations Based on Current Scientific Evidence and Standards of Clinical Care Table International Cartilage Repair Society Macroscopic Cartilage Assessment Score Criteria Appearance Points LA Level with surrounding cartilage 75 repair of defect 50 repair of defect 25 repair of defect 0 repair of defect 1 B 100 survival if initially grafted surface
605. org TIDES 2011 2011 5 22 25 _Uwe Oelmiiler http www ibclifesciences com TIDES overview xml DGP 20114 2011 6 16 19 _Sibylle Gudisch PAXgene http www pathologen kongress de 23 BCP2011 2011 8 27 9 1 _Christian Viertler _Marcel Kap PAXgene 209 _Sibylle Giidisch http www esp congress org MipTec 2011 2011 9 19 22 _Uwe Oelmiiler SPDIA http www miptec ch
606. x x 1 x Structural integrity x x Thickness defect filling x x x Osteochondral junction x x x Adjacent bonding x x x Basal integration x x Cellularity x Clustering distribution x x x x Adjacent cartilage x degeneration Mineral x x x Blood vessels x y x Subchondral bone x x Viability cell population x x Inflammation x Cartilage plug quality x PINEDA et al O DRISCOLL et al in vivo animal TABLE 1 CARTILAGE REPAIR SCORE TABLE 1 f p HISTOLOGICAL AND HISTOCHEMICAL GRADING SCALE Characteristics Score Filling of defect Score 125 l Nature of the predominant tissue 100 0 Cellular morphology 75 l Hyaline articular cartilage 4 50 2 Incompletely differentiated mesenchyme 2 25 3 Fibrous tissue or bone 0 0 4 Safranin O staining of the matrix Reconstruction of osteochondral junction Normal or nearly normal 3 Yes 0 Moderate 2 Almost l Slight 1 Not close 2 None 0 Matrix staining Structural characteristics Normal 0 Surface regularity Reduced staining 1 Smooth and intact 3 Significantly reduced staining 2 Superficial horizontal lamination 2 Faint staining 3 Fissures 25 to 100 per cent of the thickness 1 No stain 4 Severe disruption including fibrillation 0 Cell morphology Structural integrity Normal 0 Normal Ce i 2 Most hyaline and fibrocartilage 1 Slight disruption including cysts 1 Mostly fibrocartilage 2 Severe disintegration 0 Some fibrocartilage but mostly nonchondrocytic cells 3 Thickness only 4 100 per cent of normal
607. 11 24 16 00 18 15 2 2 1 23 1 2 2 WG 11 24 2 3 8 2 4 CADx 2 5 CADx 2 1 21 WG 3 1 BS gA 4 gt 2 3 8 231 4 IT
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610. 19 19 10 p209 217 2007 20 R 21 Dominici M et al Cytotherapy 8 315 317 2006 44 E TI 9 10 28 338 Guidance for Industry Bioanalytical Method Validation FDA 2001
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615. Cl 0 9 NaCl HCI pH 1 2 3 4 S 6 0 01 pH 3 5 0 05 pH 3 1 pH 2 0 01 HCI pH 2 pH 7 4 pH 6 4 10 pA cm Ti 10 nA cm2 Co 28Cr 6Mo Et Ti Ti 6Al 4V TTi 15Zr 4Nb 1 4 Ta i CES Co Ni EF Haakon lt Co Cr Mo lt Ti CrO CpQ TiO Ll
616. D p Lowess _ WES IT ExpSumTable MIAME C CDISC SEND
617. E 50 E O Ti 15Zr 4Nb 4Ta 5 ou Ti 15Zr 4Nb 1Ta G a w 30 o a ig oO g 14 20 igh K 2 P 10 0 aG 0 05 1 15 2 25 3 0 05 1 15 2 25 3 1E V vs SCE IE Vvs SCE 1 14 Ti 15Zr 4Nb 1Ta Ti 15Zr 4Nb 4Ta O CPE 1 N T C Oliveira A C Guastaldi Electrochemical stability and corrosion resistance of Ti Mo alloys for biomedical applications Acta Biomaterialia Vol 5 No 1 2009 p 399 405 2 X p 13 3 ASTM F2384 Specification for Wrought Zirconium 2 5Niobium Alloy for Surgical Implant Applications 121 4 5 S Tamura C J Powell D R Penn Calculation of electron inelastic mean free paths Surf Interface Anal Vol 21 1993 p 165 171 6 24 3 1 0301 20 122 2 3 4 5 6 7 8 9 16 11 15 No 19
618. G 2 3 12 14 2 WG 2 4 2 283 A 3 1 WG 2 3 10 178 A 2 WG 2 3 1 1 9 x 3 WG 2 3 12 14 4 WG 2 4 1 18 4 1 WG 2 4 2 144 k 2 WG 2 4 3 2 5 DNA 1 WG 2 3 11 16 2 WG 2 4 1 12 A 3 WG 2 4 2 23 6 1 WG 2 3 10 268 xK 2 WG 2 3 11 24 3 WG 23 12 22 G G ao a 4 W 2 4 1 268 5 W 2 4 2 234 WH WH MH WH Mo Wb Wb db Wb N ao 13
619. Gravimetric Measurement of Polymeric Components for Wear Assessment JIS T 0305 JIS T 0993 1 1 JIS T 0301 TST 0011 ISO 10993 1 Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process ISO 10993 2 Biological evaluation of medical devices Part 2 Animal welfare requirements ISO 10993 3 Biological evaluation of medical devices Part 3 Tests for genotoxicity carcinogenicity and reproductive toxicity ISO 10993 4 Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood ISO 10993 5 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity ISO 10993 6 Biological evaluation of medical devices Part 6 Tests for local effects after implantation ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals ISO 10993 9 Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products ISO 10993 10 Biological evaluation of medical devices Part 10 Tests for irritation and delayed type hypersensitivity ISO 10993 11 Biological evaluat
620. Mason M Hoare Regenerative medicine bioprocessing building a conceptual framework based on early studies Tissue Eng 13 301 311 2007 M Takagi Noninvasive quality estimation of adherent mammalian cells for transplantation Biotechnol Bioprocess Eng 15 54 60 2010 238 1215 1216 2011 243 250 2010 A 169 180 2010 RH 35 43 2010 52 61 2010 5
621. NA DNA DNA 2 2 1 1 DNA RNA 2 DNA DNA Tm melting temperature GC PNA LNA
622. NA 3 3 RNA RNA
623. PIDIA 2011 6 13 17 qPCR PCR http www qpcrsymposium eu SPIDIA TATAA SPIDIA 2 2 CTC 2 SPIDIA 2 SPIDIA SPIDIA SPIDIA SPIDIA 250
624. RNA RNA RNA RT PCR QIAsymphony AS QIAGEN RNA RT PCR SPIDIA i ii microRNA 3 155
625. S 13482 ISO personal care robots mobile servant robot physical assistant robot person carrier robot O 3 SO10218 AS e
626. aist go jp R amp D Guideline for the Design of a Pass Box with Decontamination Capability 2010 Draft R amp D Guideline for the Design of an Aseptic Transfer Interface 2011 Draft The guideline in English has been prepared for providing information abroad and handling inquiries from foreign countries For more information please contact The Secretariat of R amp D Guideline for Medical Device Secretariat TEL FAX 029 861 7840 E Mail human ws m aist go jp 30 5 23 R
627. am FDA 1 21 CFR 807 E 2 AD 3 TDA 3
628. anin O fast green iron hematoxylin were analyzed for abnormalities in ee population safranin O stain distribution and tidemark integrity and scores assigned as the histologic histochemical grade KNUTSEN et al Histological evaluation was performed by a pathologist in Tromso V I and a clinical scientist S R who specializes in histological analysis of cartilage Both were blinded to the type of treatment that the patient had received Concentrating particularly on the lower region of the biopsy specimen they arbitrarily ranked the repair cartilage as hyaline Group 1 fibrocartilage hyaline mixture Group 2 or fibrocartilage Group 3 or they recorded that there was no repair tissue Group 4 WAKITANI ET AL TABLE 1 HISTOLOGIC GRADING SCALE FOR DEFECT CARTILAGE Parameter Points Observation A Cell morphology Hyaline cartilage Mostly hyaline cartilage Mostly fibrocartilage Mostly noncartilage Noncartilage only Normal compared to host Slightly reduced Significantly reduced No metachromatic stain Smooth gt 3 4 Moderate 1 2 lt lt 3 4 Irregular 1 4 lt lt 1 2 Severely irregular 1 4 lt gt 2 3 1 3 lt lt 2 3 lt 1 3 E Integration of donor to host 0 Both edges integrated adjacent cartilage One edge integrated 2 Both edges not integrated Total maximum A E 14 B Matrix staining metachromasia WN KH CRwWNHHE SO C Surface regularity U D Thickness of cartilage
629. butsuri GD601 index htm 269 B gt LOKOMAT Hocoma 5 LOKOMAT Hocoma WEB http www hocoma com en products lokomat gt HAL Hybrid Assistive Limb CYBERDYNE 270 2 2
630. de at 4 C Postdecalcification trimming step facilitates collecting at least 2 section levels per defect to take into account potential heterogeneity of repair Postfixation after long periods of decalcification Trim before embed e For each specimen collect serial sections from at least 2 predetermined levels fixed distance to each other in the repair tissue 5 um paraffin sections human sheep horse or 8 to 10 um cryosections rabbit for collagen typing Stain 2 serial sections from each level for each stain e Tissue sections processed separately for electron microscopic analysis of matrix optional 4 Staining e H amp E cartilage bone interface cell morphology tidemark abnormal calcification e Safranin O or toluidine blue glycosaminoglycan content e Collagen immunostaining for collagen type and type Il e Unstained sections for polarized light microscopy PLM e Recut and stain any torn folded or poorly stained sections Verify complete set of sections use the best section free of folds tears e Blind sections or digital scans prior to scoring 5 Evaluation methods e Must be performed by 2 or 3 trained and blinded observers Blinded consensus for outlier scores e Determine implant presence absence e Histological scoring ICRS II human animal or O Driscoll animal that also assesses adjacent cartilage and cartilage repair inte gration Can use other scoring systems or evaluate predominant tissue type
631. etallic materials Part 3 Wrought titanium6 aluminium 4 vanadium alloy ISO 5832 11 Implants for surgery Metallic materials Part 11 Wrought titanium6 aluminium 7 niobium alloy ISO 7153 1 Surgical instruments Metallic materials Part 1 Stainless steel ISO 5832 4 Implants for surgery Metallic materials Part 4 Cobalt chromium molybdenum casting alloy ISO 5832 6 Implants for surgery Metallic materials Part 6 Wrought cobalt nickel chromium molybdenum alloy ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy ISO 5832 12 Implants for surgery Metallic materials Part 12 Wrought cobalt chromium molybdenum alloy ISO 5832 5 Implants for surgery Metallic materials Part 5 Wrought cobalt chromium tungsten nickel alloy ISO 5834 1 Implants for surgery Ultra high molecular weight polyethylene Part 1 Powder form ISO 5834 2 Implants for surgery Ultra high molecular weight polyethylene Part 2 Moulded forms ISO 13782 Implants for surgery Metallic materials Unalloyed tantalum for surgical implant applications ISO 21536 Non active surgical implants Joint replacement implants Specific requirements for knee joint replacement implants ISO 21534 Non active surgical implants Joint replacement implants Particular requirements ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Su
632. hemicals using a customized DNA microarray Environ Health Persp 112 773 781 3 Ise R Han D Takahashi Y Terasaka S Inoue A Tanji M and Kiyama R 2005 Expression Profiling of the Estrogen Responsive Genes in Response to Phytoestrogens Using a Customized DNA Microarray FEBS Lett 579 1732 1740 4 Terasaka S Inoue A Tanji M and Kiyama R 2006 Expression profiling of estrogen responsive genes in breast cancer cells treated with alkylphenols chlorinated phenols parabens or bis and benzoylphenols for evaluation of estrogenic activity Toxicol Lett 163 130 141 5 Dong S Inoue A Zhu Y Tanji M and Kiyama R 2007 Activation of rapid signaling pathways and the subsequent transcriptional regulation for the proliferation of breast cancer MCF 7 cells by the treatment with an extract of glycyrrhiza glabra root Food Chem Toxicol 45 2470 2478 6 Parveen M Inoue A Ise R Tanji M and Kiyama R 2008 Evaluation of estrogenic activity of phthalate esters by gene expression profiling using a focused microarray EstrArray Environ Toxicol Chem 27 1416 1425 7 Parveen M Zhu Y and Kiyama R 2009 Expression profiling of the genes responding to zearalenone and its analogues using estrogen responsive genes FEBS Letters 583 2377 2384 8 Dong S and Kiyama R 2009 Characterization of estrogenic activity of ginsenosides in MCF 7 cells using a customized DNA microarray Food Chem 113 672 678
633. imal Models and Clinical Trials Table 3 Guidelines for Histological Processing and Analyses of Repair l Lesion size and location e Human 2 mm diameter l cm deep biopsy from estimated geometric center of initial lesion perpendicular to surface Sample includes bone full thickness repair e Animal sample block includes entire defect flanking articular cartilage subchondral bone encompassing potential regions of bone resorption 2 Timing of biopsy and sample recovery e Human biopsy 12 month or 24 month outcome one biopsy per lesion Macroscopic ICRS score Video document and detailed description of biopsy site e Animal acute defect 0 3 days and long term repair 22 months rabbit or 26 months large animal with and without treatment Exact endpoints can be tailored to individual studies and should provide information on the rate of implant incorporation or degradation in the joint Macroscopic score whole joint Take any biochemistry or biomechanics samples prior to tissue fixation 3 Histoprocessing for cartilage bone analysis e Fixation in 10 normal buffered formalin or buffered 4 paraformaldehyde e Human decalcify biopsies with bone for 30 hours in 0 5 N HCI 0 1 glutaraldehyde or formic acid or 2 weeks in 0 5 M EDTA at 4 C e Animal decalcify 10 days rabbit distal femur or weeks large animal samples in 0 5 N HCI with or without 0 1 glutaralde hyde or longer in 10 EDTA 0 1 paraformaldehy
634. ion of medical devices Part 11 Tests for systemic toxicity ISO 10993 12 Biological evaluation of medical devices Part 12 Sample preparation and reference materials ISO 10993 13 Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices ISO 10993 14 Biological evaluation of medical devices Part 14 Identification and quantification of degradation products from ceramics ISO 10993 15 Biological evaluation of medical devices Part 15 Identification and quantification of degradation products from metals and alloys ISO 10993 16 Biological evaluation of medical devices Part 16 Toxicokinetic study design for degradation products and leachables ISO 10993 17 Biological evaluation of medical devices Part 17 Establishment of allowable limits for leachable substances ISO 10993 18 Biological evaluation of medical devices Part 18 Chemical characterization of materials ISO 10993 8 Biological evaluation of medical devices Part 8 Selection of reference materials 23 3 30 0330 5 GMP QMS 4 4
635. nd in vitro tissue engineering scores in green Histological scoring of cartilage Osteoarthritic in vivo repaired ie a cartilage cartilage J cartilage Grading x 7 S racing ony staging Simple Comprehensive sees JC a Simple OA Bendele 2001 Simple comprenensive i O Driscoll OsScore Semi 1986 Knutsen quantitative Peterson Score VHS VAS Fig 5 Choice of an appropriate scoring system may be aided by a flow diagram Validated scores are presented in bold Visual assessment scale 4 23 FDA
636. neralization calcified cartilage Normal Abnormal inappropriate location The observer attempts to evaluate one feature at a time The most prominent feature on each specimen is matched to a graded panel of images that it most closely resembles The high est score 3 is applied to the ideal repair result i e truly regen erated tissue and the lowest score 0 is applied to the poorest repair result The scores should not be summed rather each score should be reported separately i e 1 3 1 3 1 2 IV 1 V 4 VI 3 71 OsScore Table 3 Histological features measured for OsScore Feature Score Tissue morphology Hyaline 3 Hyaline fibrocartilage 2 Fibrocartilage 1 Fibrous tissue 0 Matrix staining Near normal 1 Abnormal 0 Surface architecture Near normal 2 Moderately irregular 1 Very irregular 0 Chondrocyte clusters None 1 lt 25 cells 0 5 gt 25 cells 0 Mineral Absent 1 Present 0 Blood vessels Absent 1 Present 0 Basal integration Good 1 Poor 0 Maximum total possible 10 O DRISCOLL et al 2001 TABLE 1 HISTOLOGICAL HISTOCHEMICAL SCORING SYSTEM Histological Histochemical Findings Score Chondrocytes Safranin O Staining 0 None or almost none None or almost none 1 lt 50 Slight 2 gt 50 Moderate 3 All or almost all Normal or nearly normal 72 The Bern Score For the Evaluation of Safranin O Fast Green Stained Cartilagenous Pellet Cultures Minimum Sco
637. nosis CAD X CAD CAD CAD CADe Computer Aided Detection CADx Computer Aided Diagnosis CADx
638. ol number for this information collection is 0910 0557 expires 12 31 2007 The time required to complete this information collection is estimated to average 10 hours per response including the time to review instructions search existing data resources gather the data needed and complete and review the information collection 2 An Analysis of Blood Processing Methods to Prepare Samples for GeneChip Expression Profiling Technical Note from Affymetrix http www affymetrix com support technical technotes blood_technote pdf 3 Fan H 2005 The transcriptome in blood challenges and solutions for robust expression profiling Current Molecular Medicine 5 3 10 4 Debey S et al 2006 A highly standardized robust and cost effective method for genome wide transcriptome analysis of peripheral blood applicable to large scale clinical trials Genomics 87 653 664 5 Burczynski M E and Dorner A J 2006 Transcriptional profiling of peripheral blood cells in clinical pharmacogenomic studies Pharmacogenomics 7 187 202 6 Baechler E C 2004 Expression levels for many genes in human peripheral blood cells are highly sensitive to ex vivo incubation Genes and Immunity 5 347 353 7 Debey S 2004 Comparison of different isolation techniques prior gene expression profiling of blood derived cells impact on physiological responses on overall expression and the role of different cell types The Pharmacologics Journal 4 193 207
639. oscopic Cartilage Assessment Score Outerbridge Classification 48 1 I ICRS II O Driscoll Wakitani smooth and intact or I I
640. r Exchange of Nonclinical Data SEND Implementation Guide for Animal Toxicology Studies can be obtained from the CDISC Web site at http www cdisc org models send v2 3 SENDV2 3ImplementationGuide pdf 200 3 4 3 BRIN SPIDIA 2 24 1 12 SPIDIA SPIDIA 2011 10 SPIDIA Newsletter 10 2011 October 2011 SPIDIA 2011 10 SPIDIA www SPIDIA eu SPIDIA SPIDIA SPIDIA SPIDIA Contact Us www SPIDIA_ eu SPIDIA
641. re 0 Maximum Score 9 Scoring categories Score Category A Uniformity and darkness of Safranin 0 Fast green stain 10X objective No stain 0 Weak staining of poorly formed matrix 1 Moderately even staining 2 Even dark stain 3 Category B Distance between cells amount of matrix accumulated 20X objective High cell densities with no matrix in between no spacing between cells 0 High cell densities with little matrix in between cells lt 1 cell size apart 1 Moderate cell density with matrix cells approx 1 cell size apart 2 Low cell density with moderate distance between cells gt 1 cell and an extensive matrix 3 Category C Cellular morphologies represented 40X objective Condensed necrotic pycnotic bodies 0 Spindle fibrous 1 Mixed spindle fibrous with rounded chondrogenic morphology 2 Majority rounded chondrogenic 3 Source Grogan SP et al Tissue Eng 2006 12 8 2141 9 73 Osteoarthritis and Cartilage Vol 18 No 1 13 Huang OARSI Mankin Foland Hotta Otte Colombo Bendele Freemont Yagi Colllins es oe os oe os es ee oe 1 1949 1959 1969 1979 1989 1999 2009 O Driscoll OsScore ICRS II Pineda Peterson Wakitani ICRS I Knutsen O Driscoll Bern Fig 1 Chronological development of cartilage histological scores after the first macroscopical score in 1949 Collins OA scores are presented in blue in vivo cartilage repair scores in red a
642. rgical Implants ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications UNS R05200 UNS R05400 ASTM F1108 Standard Specification for Titantum 6Aluminum 4Vanadium Alloy Castings for Surgical Implants UNS R56406 ASTM A276 Standard Specification for Stainless Steel Bars and Shapes ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications UNS R50250 UNS R50400 UNS R50550 UNS R50700 ASTM F75 Standard Specification for Cobalt 28Chromium 6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants UNS R30075 ASTM F90 Standard Specification for Wrought for Surgical implant Applications UNS R30605 ASTM F136 Standard Specification for Wrought Titanium 6Aluminum 4 Vanadium ELI Extra Low Interstitial Alloy for Surgical Implant Applications UNS R56401 ASTM F138 Standard Specification for Wrought 18Chromium 14Nickel 2 5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS S31673 ASTM F139 Standard Specification for Wrought 18Chromium 14Nickel 2 5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants UNS S31673 ASTM F620 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants ASTM F621 Standard Specification for Stainless Steel Forgings for Surgical Implants 124 37 38 39 40 41 42 43 44 45 46 47 48 49 50 SD 52 53 54 55 56 57
643. ross validation for model selection BMC Bioinformatics 7 91 8 Guo L Lobenhofer EK Wang C Shippy R Harris SC Zhang L Mei N Chen T Herman D Goodsaid FM Hurban P 199 Phillips KL Xu J Deng X Sun YA Tong W Dragan YP Shi L 2006 Rat toxicogenomic study reveals analytical consistency across microarray platforms Nat Biotechnol 24 9 1162 1169 Canales RD Luo Y Willey JC Austermiller B Barbacioru CC Boysen C Hunkapiller K Jensen RV Knight CR Lee KY Ma Y Maqsodi B Papallo A Peters EH Poulter K Ruppel PL Samaha RR Shi L Yang W Zhang L Goodsaid FM 2006 Evaluation of DNA microarray results with quantitative gene expression platforms Nat Biotechnol 24 9 1115 22 Smythe et al BMC Infectious Diseases 2002 2 13 a Yokota et al Journal of Clinical Laboratory Analysis 1999 13 133 140 22 Shi L Tong W Goodsaid F Frueh FW Fang H Han T Fuscoe JC and Casciano DA 2004 QA QC challenges and pitfalls facing the microarray community and regulatory agencies Expert Rev Mol Diagn 4 761 77 23 Shi L Tong W Fang H Scherf U Han J Puri RK Frueh FW Goodsaid FM Guo L Su Z Han T Fuscoe JC Xu ZA Patterson TA Hong H Xie Q Perkins RG Chen JJ and Casciano DA 2005 Cross platform comparability of microarray technology intra platform consistency and appropriate data analysis procedures are essential BMC Bioinformatics 6 Suppl 2 S12 24 Thompson KL Rosenzweig BA Pine PS Retief
644. ting hinge CR SS z gt PSB B4Vt 5mm A 3 A 4 3 Offset Stem Extension Set Fek Re MIS Modular Stemmed Porous fren KERIO S y gt gt p i AIERT Re aah eb Offset Stem Extension gt Pare Oe 3 ERTA eb 2 gt e A Mee ed EBATL LIAFVYav A5 92 B B 1 B 1 B 1
645. ting subchondral bone 2 Matrix staining metachromasia 0 100 Grade 4A Penetration of subchondral bone in part of 3 Cell morphology 0 100 the defect 4 Chondrocyte clustering 0 100 Grade 4B Subchondral bone penetration involving 5 Surface architecture 0 100 complete defect 6 Basal integration 0 100 Osteochondral P 7 Tidemark formation 0 100 Defects 8 araa bone abnormalities marrow DD Type Stable continuity softened area covered by i is aan intact cartilage io PPP ol 00 Type 2 Partial discontinuity stable on probing oS cone 3 Type 3 Complete discontinuity dead in situ not 11 Vascularization in repair tissue 0 100 dislocated 12 Surface superficial assessment 0 100 Type 4A Dislocated fragment loose within the bed 13 Midzone deep zone assessment 0 100 or empty defect 14 Overall assessment 0 100 Type 4B Loose and dislocated fragment gt 10 mm in Note From Mainil Varlet et al 68 Review Evaluation of histological scoring systems for tissue engineered repaired and osteoarthritic cartilage Osteoarthritis and Cartilage 2010 18 12e23 69 Table IV Parameters assessed by some major cartilage repair scores Parameters of the O Driscoll Pineda Wakitani Modified OsScore ICRS Knutsen ICRS Il different grading et al et g 5 et al Mankin VHS et al VAS 48 systems Uhl et al Cell morphology x x x x x x x x Matrix staining x x x x Surface regularity x x
646. www fda gov cder guidance index htm 176 1401 Rockville Pike Rockville MD 20852 1448 http www fda gov cber guidelines htm 800 835 4709 or 301 827 1800 HFZ 220 1350 Piccard Drive Rockville MD 20850 4307 U S A http www fda gov cdrh ggpmain html dsma cdrh fda gov Fax 301 443 8818 800 638 2041 301 443 6597 301 827 3993 I Il A RNA 1 RNA 2 RNA 3 PBMC RNA 4 RNA 5 RNA QC B C D E F Ill A B DNA

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