Incurred sample reanalysis: A global transformation

Bioanalysis

Volumn 3, Issue 23, 2011, Pages 2601-2602

  Viswanathan, Chidambaram T ^a  

^a CT Viswanathan and Associates Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOEQUIVALENCE; DRUG INDUSTRY; DRUG SAFETY; INCURRED SAMPLE REANALYSIS; PRACTICE GUIDELINE; QUALITY CONTROL; REPRODUCIBILITY; SAMPLE SIZE; STANDARDIZATION;

CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG STABILITY; GUIDELINES AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; THERAPEUTIC EQUIVALENCY;

EID: 82955168442     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.20     Document Type: Article

References (2)

1. Viswanathan CT, Bansal S, Booth B et al. Bioanalytical method validation and implementation: best practices for chromatographic and ligand-binding assays. AAPS J. 9(1), E30-E38 (2007).
2. Fast D, Kelley M, Viswanathan C et al. Workshop report and follow-up-AAPS workshop on current topics in GLP bioana lysis: assay reproducibility for incurred samples-implications of Crystal City recommendations. AAPS J. 11(2), 238-241 (2009).