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Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective
Authors:Findlay J W  Smith W C  Lee J W  Nordblom G D  Das I  DeSilva B S  Khan M N  Bowsher R R
Affiliation:

a Metabolism and Safety Evaluation, Searle, 4901 Searle Parkway, Skokie, IL 60077, USA

b Statistical and Mathematical Sciences, Lilly Research Laboratories, Eli Lilly and Company, Greenfield, IN 46140, USA

c MDS Harris, 621 Rose Street, Lincoln, NE 68502, USA

d Department of Pharmacokinetics, Dynamics and Metabolism, Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co., 2800 Plymouth Road, Ann Arbor, MI 48105, USA

e Bioanalytical, Procter and Gamble Pharmaceuticals, Route 320 Woods Corners, Norwich, NY 13815, USA

f Clinical Testing Laboratory, Quality Control Department, MedImmune Inc., 636 Research Drive, Frederick, MD 21703, USA

g Drug Disposition, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA

Abstract:
Keywords:Pharmaceutical   Drug development   Immunoassays   Biomarkers   Antibodies   Assay validation   Bioanalytical   Calibration   Immunogenicity
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