PDFファイル - 医薬品医療機器総合機構
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1.2. 7 6 66 20 7 x 8 1 1 ng mL 6 11 8
3. J 5 3 3 2000 5 3 5 4 5
4. 8C 1 1 RO79UL 1 G 88omLX1 11mLX 1 ROISUL 1 16mLX1 8mLX1 1 Schran HF et al Determination of cyclosporine concentrations with monoclonal antibodies C in Chem 1987 33 9225 2229 2 Wong PY et al Quality assessment of cyclosporine monitoring Canadian validations Transplant Proc 1990 22 1216 1217 3 Biosafety in Microbiological and Biomedical Laboratories JY Richmond RW McKinney eds Atlanta GA US Dept of Health and Human Services Public Health Service Centers for Disease Control and Prevention Bethesda MD National Institutes of Health 1993 4 Occupational Exposure to Bloodborne Pathogens Final Rule Federal Register Part Il Department of Labor Occupational Safety and Health Administration 29 CFR Part 1910 1030 Friday December 6 1991 5 Clinical and Laboratory Standards Institute NCCLS Interference testing for clinical chemistry CLSI NCCLS proposed guideline EP7 P February 1982 Clinical and Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne
5. CLSI NCCLS 800ng mL 800ng mL 10 1 zh ug mL nid ug mL 200 70 0 18 60 60 4 0 37 12 20 4 B 20 100 40 1000 10 0 015 50 6
6. 15 28 45 67 ng mL 929 0 9320 1008 9 993 8 930 5 allis 96 100 3 108 6 1070 1002 5 CLSINCCLS 350 G000ng mL 19 z 19 1 022 YJE 3 80 r 0 998 6 350ng mL x 209 6 1 HIV HBV HCV
7. 6 1 1 9 SD SD SD N ng mL ng mL ng mL ng mL N ng mL ng mL 7 1 ID 123 47 9 330 126 9 279 89 E M d Sun pu ea P aa Jere e ma amu ae fe e n 8 205 77 N1 276 104 8 aaa soo MAISEGECIDHICNUT GO C MRED EENDANY HUN
8. G00ng mL 9 00ng mL 800ng mL ng mL 96 ng mL 96 AMI M17 500 0 3 1000 5 9 AM19 M8 500 3 0 1000 9 7 AMAN M21 500 0 3 1000 0 9 AM9 M1 670 7 3 1000 5 5 AM 1c M18 1000 1 0 1000 2 7 AM 1c9 M26 1000 1 9 800 5 AM4n9 M13 1000 2 0 1000 Novartis Pharmaceuticals Physicians Desk Reference d O TREE U s Uc P 450
9. c NM i NN 9596 P MM 13 4 30 8 5 7 55 9 GOOng mL 87 8 9 2 3 1 15 3 ord sub xm Eo dE 1 CEXSEME E i 3 So AA AEA n EEAO OEA 4 lt 500ng mL 115 4 3 596 0 1 6 896 500ng mL 28
10. c 2000 0 50 100 200 350 500ng mL Emit2000 Cyclosporine Specific Calibrators CSAE O 200 400 800 1400 2000ng mL Siemens Healthcare Diagnostics CSAE Calibrato 2000
11. Prim HIV HBs 2 EN A tod c on eA A 1
12. Leuconostoc mesenteroides G6PDH 6R719UL 2000 1 100uL EDTA
13. H P 450 o H G00ng mL 800ng mL
14. EDTA 8 18 25C 2 8C 1 G0C 20C 3 3
15. 6 zip 50 100 10 64 5 14 16 5 1 5 dedi 100 150 26 167 39 109 17 5 4 150 200 34 218 64 179 17 BA 200 250 26 16 7 70 19 6 32 0 2 ES EO S i e U Z2 LL 4 e St Des RES AS Tec S8 FEE LC SED C 250 300 24 154 52 145 37 1 8 300 350 16 10 3 48 13 4 36 1 5 1 350 400 5 3 2 31 8 7 33 0 5 3 400 450 3 1 9 17 4 7 40 2 7 a 5 3 0 D o o 18 5E gt 600 3 19 12 34 34 0 8 E l o ed 7 BEKS EESEXIUSZL7J E E 58 red Jlcst 9 o PEN Z HN 4 E ou ui p E ue 81
16. 10 LC MS FPIA 15 15 SE r LC MS A 1a 27H AE E F 1 00 42 1 0971 40 1 14 49 0 0 951 59 3 26 CLS d Eo ces 193 NCCLS the National Committee for Clinical Laboratory 1 14 il Dos a im cy Ex E RE pu ir c ca na E 0
17. 1 2 20 3 n 120 9 COBAS MIRA amp COBAS MIRA S 3 11 n 9 SD ng mL ng mL LC MS 2000 y 1 01x 36 1 r 0 971 n 138 1500 1000 500 500 FPIA 1000 LCMS ng mL y 1 13x 92 4 r 0 969 n 134 1500 2000 200 400 600 800 1000 1200 1400 1600 1800 FPIA ng mL 3 OLSI NCCLS 5 3 1 0 2 n 80 16 SD CV96 16 g Within r
18. pis 1 1 omg dL 6 1983 2000 COBAS MIRA 6
19. AE nA E E A A 1 1 2 1 1 ER
20. 3930 20 10 30 1 5 8 1 30 GO
21. ft HIV HBV E 0 196 HMS Ix cur S S RAI a Ri wy e
22. nili 70ng mL 3096 130ng mL 3096 4 500ng mL ng mL 50 100 3096 101 gt 150 6096 151 300 6096 301 400 2096 5 350ng mL 2000ng mL T ng mL 401 800 PSE 20 801 1400 PE 20 5 1401 1900 096 a 3 D 50 100ng mL 3096 E IRR 2096 5 SI por
23. 1096 3 i 40mg dL 60mg dL 500mg dL 500mg dL 3000mg dL 1500mg dL 0mg dL 20mg dL 12g dL 12g dL 12g dL 12g dL 500IU mL 500IU mL l e 3 4 H E 7C a 8C 8 1
24. x y YU 45 3 9 13 3 RIA p 0 8 0 70 0 7 1 0 82 24 0 968 2678 59g3 21 2699 245 1 6 5 0 91 4 0 934 4043 113 37 265 1 236 6 0 ng mL 9596 40 3 0 79 8 10 929 3569 786 38 309 7 252 5 ng mL 4 0 84 13 0 981 24 56 650 40 311 3 257 9 7 HPLC Cyclosporine USP 02 24 0 965 2539 s595 21 217 5 244 9 8 350 2000ng mL 5 114 3 0917 3971 113 37 205 7 231 9 s TE 3 OS92 9 O828 50 68 030 38 277 7 263 1 4 1 05 12 0 975 2533 1645 40 252 6 277 0 1 HPLC RIA 350 1 1 24 0 0976 23 66 595 21 220 1 272 7 000ng mL C 5 1 29 3 0 912 4317 1045 37 207 9 265 3 2 3 1 1 1 0 818 5909 663 38 279 5 312 2 4 1 24 110 977 8638 648 40 252 6 312 5
25. 5 1 3 t34 statistical outlier test 1 3 9 3 9 4 3 4 5 100ng mL Dn
26. rs Emit2000 Cyclosporine Sample Pretreatment Reagent HPLC 200uL 300uL 100uL 500uL 5mL 1 5 2 0mL 2000
27. 77 8ng mL 166 7 187 4ng mL 3 390 6 Cg COBAS MIRA PLUS COBAS MIRA COBAS MIRA S 1 4 HPLC RIA FPIA 85ng mL 425ng mL 3 10 1 DI X 12 REDRE MRE ng mL 85 425 5O0ng mL 500ng mL ng mL 82 5 90 7 408 4 459 4 0 015
28. 120 CD3 230 1000 250 5 100 14 43 150 250 100 0 02 8 eb 3 30 Te 200 1 3500 10 81 ums 200 20 0 1 400 500 120 400 8000U L 0 1 32 250 40 2 8 5000 20 70 500 0 06 630 00ng mL 800ng mL
29. CV96 1 1 BMD Within run Total 19985 mg m Lake Louise Consensus Conference 9 SD CV SD CV FER us AES ROLES AUC 414 148 261 88 61 269 356 83 85 c 9 3 3 DI 1 63 3
30. G6P DH 6 G6PDH NAD NADH
31. 9 97 106 796 96 1 108 196 80 15096 15 5996 5 3 75ng mL 425ng mL 2 5 13 CV 1596 4 13 40 x FZU v F 96 15 26 37 46 59 500ng mL 1500ng mL 75ng mL bacc euis QUA Sd po Mee GEM Cuius
32. statistical outlier test 9 3 2 25SD M nm 1296 2 25SD 2596 Me 259 20 4 EE
33. 100 350ng mL HESSOBHRBI S OSRUENE 7696 x drea cad RE 100 350ng mL 9 ue adu x Jis 7 DZURtU v ORI Lc EATER tA 9 io 3 B i C 7I c o0 085 ra c ic 9 X 2 Ru orm uc TERRIER I 5 5 DE REER Uf RE C S bp du gc mu E 1 BE
34. NI 3 Da A E Lo 6 AZe5ng mL 2 aps 96 91 3 97 7 97 5 101 101 CV 90 64 53 75 79 87 3 1 5 3 4 COLSI NCCLS 40 500ng mL 25000 14 RIA 14 HPLOC COBAS MIRA Plus COBAS MIRA COBAS MIRA S 10 N 20 20 20 10 0 97 0 98 1 05 Mee
35. 3 10 796 0 7 22 296 Bi F g 132 30 65 BREE 374 FRE RG FO ENS 138 4000 FH 37 318 127 E CA 1 lt 350ng mL 126 4 3 296 0 6 296 SW a pem 6 6 26 9 6 8 9 1 1 2mg dL icu ER 7mg dL B E Ds
36. Pennsylvania 19087 1898 USA 6 Physician s Desk Heference ed 57 Montvale NJ Thompson PDR 2003 pp 28310 2312 7 McMillan MA Clinical pharmacokinetics of cyclosporin Pharmac Ther 1989 42 135 156 8 Kahan BD Cyclosporine N Engl J Med 1989 321 1725 1738 9 Keown Paul A New concepts in cyclosporine monitoring Current opinion in nephrology and hypertension England Nov 2002 11 6 p619 26 10 Oellerich M et al Lake Louise Consensus Conference on Cyclosporine Monitoring in Organ Transplantation Report of the Consensus Panel Therapeutic Drug Monitoring 17 642 654 1995 11 Holt David W Therapeutic drug monitoring of immunosuppressive drug in kidney transplantation Current opinion in nephrology and hypertension Nov 2002 1 1 6 p657 663 12 Levy G A C2 Monitoring Strategy for Optimising Cyclosporin Immunosuppression from the Neoral formation BioDrugs 2001 15 5 p2 79 90 13 Clinical and Laboratory Standards Institute NCCLS Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guideline Second Edition CLSI NCCLS document EP5 T2 March 1992 Clinical and Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 14 Clinical and Laboratory Standards Institute NCCLS Evaluation of the linearity of quantitative analytical methods CLSI NCCLS proposed guideline EP6 P August 1988 Clinical and Laboratory Standard Institute 940 West Valley Road S
37. SIEMENS 2000 Emit 2000 Cyclosporine Specific Assay 6R079UL 6R019UL 013 4 2 10 2008 1 13AoX10031001008 1 Antibody Substrate Reagent A NAD 6 G6P Enzyme Reagent B 6
38. uite 1400 Wayne Pennsylvania 19087 1898 USA 15 Clinical and Laboratory Standards Institute NCCLS Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guideline Second Edition CLSI NCCLS document EP5 A Clinical and Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA TEL 03 3493 8400 1 1 1 1 DL 117 019G 6R004UL 16DS_US_C
39. un Total SS SD CV SD CV 402 8 16 3 40 29 3 73 887 7 29 0 33 52 2 59 1429 5 69 2 48 124 7 8 7 4 EDTA 4 5 KIZ 500ng mL 1000ng mL 1750ng mL 17 ng mL 500 ng mL H 485 96 9796 n EENE 15 679 4 800ng mL 6 6 18
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