Workshop on bioanalytical methods validation for macromolecules: Summary report

被引：54

作者：

Miller, KJ

Bowsher, RR

Celniker, A

Gibbons, J

Gupta, S

Lee, JW

Swanson, SJ

Smith, WC

Weiner, RS

机构：

[1] Amgen Inc, Pharmacokinet & Drug Metab, Thousand Oaks, CA 91320 USA

[2] Eli Lilly & Co, Indianapolis, IN 46285 USA

[3] Wyeth Ayerst Res, Genet Inst, Andover, MA 01810 USA

[4] Jacqueline Gibbons Consulting, Piedmont, CA 94611 USA

[5] Amgen Inc, Clin Immunol, Thousand Oaks, CA 91320 USA

[6] MDS Pharma Serv, Lincoln, NE USA

[7] Bristol Myers Squibb Co, New Brunswick, NJ 08903 USA

[8] Univ Utrecht, NET, Utrecht, Netherlands

[9] Washington Univ, St Louis, MO 63130 USA

[10] Proctor & Gamble Pharmaceut, Mason, OH 45040 USA

[11] Pharmacia Corp, Skokie, IL 60077 USA

[12] Roche Mol Syst, Pleasanton, CA 94588 USA

[13] MedImmune Inc, Frederick, MD 21703 USA

[14] Pharmacia & Upjohn Inc, Kalamazoo, MI 49007 USA

[15] Warner Lambert Parke Davis, Ann Arbor, MI 48105 USA

[16] Phoenix Int Life Sci, St Laurent, PQ H4R 2N6, Canada

[17] Glaxo Wellcome Inc, Res Triangle Pk, NC 27709 USA

[18] PPD Dev, Richmond, VA 23230 USA

来源：

PHARMACEUTICAL RESEARCH | 2001年 / 18卷 / 09期

关键词：

bioanalytical methods validation; macromolecules; ligand-binding assay; immunoassays; ELISA; EIA; RIA; anti-drug; bioassay; biomarker; total error; assays; quality control; acceptance criteria; specificity; accuracy; precision; recovery; calibration; drug development; neutralizing antibody;

D O I：

10.1023/A:1013062600566

中图分类号：

O6 [化学];

学科分类号：

0703 [化学];

摘要：

[No abstract available]

引用

页码：1373 / 1383

页数：11

共 14 条

[1]

[Downing GJ. NIH Definitions Working Group NIH Definitions Working Group], 2000, Biomarkers and surrogate endpoints: clinical research and applications

[2]

FDA, 1999, M BIOL RESP MOD ADV

[3]

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective [J].