☆ 4.5 Article

Workshop on bioanalytical methods validation for macromolecules: Summary report

PHARMACEUTICAL RESEARCH (2001)

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Journal

PHARMACEUTICAL RESEARCH
Volume 18, Issue 9, Pages 1373-1383

Publisher

KLUWER ACADEMIC/PLENUM PUBL
DOI: 10.1023/A:1013062600566

Keywords

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

Categories

Chemistry, Multidisciplinary Pharmacology & Pharmacy

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