: / FDA HBsAg HIV 1/2 HCV : QMS : 3.5% IgM () 1.0% H317 - H334 - : : :: : QMS Everolimus : 6.4% (II) H400 - H % SDS QMS EDTA (K 3 ) EDTA (K 2 )

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1 QMS (EVER) (QMS) QMS QMS X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 1 T / T G1 S 3 (CsA) T G0 G1 T ( ) 1-3 4,5 6-8 QMS QMS x 22 ml 1 x 8 ml 1 x 8 ml QMS CAL A-F: 1 x 3.0 ml QMS 1-3: 1 x 3.0 ml (HPLC ) IgM () 3.5% (HSA) 1.0% ( ) <1.0% <0.6% (II) 6.4% 2 ( ) : 2 8 C 32 C

2 : / FDA HBsAg HIV 1/2 HCV : QMS : 3.5% IgM () 1.0% H317 - H334 - : : :: : QMS Everolimus : 6.4% (II) H400 - H % SDS QMS EDTA (K 3 ) EDTA (K 2 ) QMS -25 C -15 C 2 8 C (-20 5 C) QMS ( ) L L 5. QMS 50 L : 7. 13,400 x g nm QMS CAL A (0.0 ng/ml) 20 ng/ml QMS CAL A (0.0 ng/ml) 1:1 1.5 ng/ml = x = ( + CAL A ) QMS (6 ) QMS A B C D E F 2 2 : CAL A / / QMS : 2 QMS ng/ml QMS QMS QMS QMS QMS ( ) ( ) 3 8 ng/ml 1 : 2

3 QMS (LOQ) ( CV 20% 15% ) LOQ 1.3 ng/ml ng/ml (%) % 12 % CV (%) QMS LC/MS Passing-Bablok Y (R) QMS LC/MS Passing-Bablok 1.00 Y (R) QMS LC/MS Passing-Bablok 0.98 Y (R) NCCLS EP5-A SD CV (%) N SD CV (%) SD CV (%) SD CV (%) NCCLS EP7-A 11,12 QMS QMS 5 ng/ml 2 QMS : (%) RAD SA RAD SA RAD PSA RAD PSA RAD PC RAD PC /46 OH RAD ND 45/46 OH RAD OH RAD OH RAD OH RAD OH RAD ND = QMS 5.5 ng/ml QMS (%) ; 7,41-O O O- -; 7-O N N- 41-O-; 32-O

4 QMS 10% N (%) 60 mg/dl mg/dl mg/dl g/dl HAMA* HAMA* % IU g/dl mg/dl mg/dl * HAMA = 5 6 ng/ml (µg/ml) (%) 200 ND N- 120 ND ND 60 ND B ND 40 ND 10 ND (5:1 : ) ND ND 250 ND 100 ND A 1 ND ND ND 100 ND 1000 ND 75 ND 20 ND 60 ND 0.0 () (µg/ml) (%) 40 ND ND 40 ND 400 ND ND 70 ND HCl 0.06 ND 17 ND A 100 ND B 100 ND 10 ND 200 ND 100 ND 22.2 ND HCl 5100 ND 240 ND 910 ND 4 ND ND 6 ND 250 ND 333 ND ND ND G ND ND 25 ND 12 ND 12 ND ND 0.5 ND 100 ND 200 ND ND ND ND 20 ND 4

5 () (µg/ml) (%) ND HCl ND 10 ND ND = 1. Certican (Everolimus) dispersible tablets proposed labeling. Novartis NDA No and December 19, Kovarik JM, Kaplan B, Silva HT, et al. Exposure-response relationships for everolimus in de novo kidney transplantation: defining a therapeutic range. Transplantation 2002;73(6): Nashan B. The role of Certican (Everolimus, Rad) in the many pathways of chronic rejection. Transplant Proc 2001; 33: Holt DW. Therapeutic drug monitoring of immunosuppressive drugs in kidney transplantation. Curr Opin Nephrol Hypertens 2002;11(6): Kahan BD, Keown P, Levy GA, et al. Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther 2002;24(3): McMahon LM, Luo S, Hayes M, et al. High-throughput analysis of everolimus (RAD001) and cyclosporine A (CsA) in whole blood by liquid chromatography/mass spectrometry using a semi-automated 96-well solid-phase extraction system. Rapid Commun Mass Spectrom 2000;14: Brignol N, McMahon LM, Luo S, etal. High-throughput semi-automated 96-well liquid/liquid extraction and liquid chromatography/mass spectrometric analysis of everolimus (RAD001) and cyclosporine A (CsA) in whole blood. Rapid Commun Mass Spectrom 2002;15: Streit F, Armstrong VW, Oellerich M, et al. Rapid liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of sirolimus, everolimus, tacrolimus, and cyclosporine A in whole blood. Clin Chem 2002;48(6): Bablok W, Passing H, Bender R, Schneider B. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry. Part III J Clin Chem Clin Biochem 1988;26(11): Tholen DW, Kallner A, Kennedy JW, et al. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (EP5-A2). Wayne, PA: The National Committee for Clinical Laboratory Standards, Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical Chemistry (EP7-A) Villanova, PA. The National Committee for Clinical Laboratory Standards, McEnroe RJ, Burritt MF, Powers DM, et al. Interference Testing in Clinical Chemistry: Approved Guideline-Second Edition (EP7-A2). Wayne, PA: The National Committee for Clinical Laboratory Standards, Microgenics Corporation Kato Road Fremont, CA USA : B R A H M S GmbH Neuendorfstrasse Hennigsdorf, Germany : : Thermo Fisher Scientific 2017 Thermo Fisher Scientific Inc. All rights reserved. Certican Novartis Thermo Fisher Scientific I-JA

No21Vol1.indd

No21Vol1.indd ( ): - PSA Shojiro Kano Head, Working Group of PSA Testing Standardization Committee (PSA) PSA PSA JCCLS PSA A PSA B PSA PSA Wang PSA FDA Hybritech Tandem-R PSA PSA PSA PSA - (ACT) - (AMG) ACT (PSA-ACT)