Key elements of bioanalytical method validation for macromolecules

AAPS Journal

Volumn 9, Issue 2, 2007, Pages

  Kelly, Marian ^a   DeSilva, Binodh ^b  

^a CENTOCOR INC   (United States)

^b AMGEN INC   (United States)

Author keywords

Bioanalytical validation; Biological matrices; Immunoassay; Ligand binding assays; Macromolecules

Indexed keywords

LIGAND; REAGENT;

ACCURACY; ANALYTIC METHOD; ARTICLE; CONFIDENCE INTERVAL; FOOD AND DRUG ADMINISTRATION; IMMUNOASSAY; LIGAND BINDING; MACROMOLECULE; NONLINEAR REGRESSION ANALYSIS; STATISTICAL ANALYSIS; VALIDATION PROCESS; WORKSHOP;

ANTIBODIES, MONOCLONAL; IMMUNOASSAY; INDICATORS AND REAGENTS; LIGANDS; MACROMOLECULAR SUBSTANCES; PHARMACEUTICAL PREPARATIONS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 34249277443     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj0902017     Document Type: Article

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