Key elements of bioanalytical method validation for small molecules

AAPS Journal

Volumn 9, Issue 1, 2007, Pages

  Bansal, Surendra ^a,c   DeStefano, Anthony ^b  

^a HOFFMANN LA ROCHE INC   (United States)

^b PROCTER AND GAMBLE PHARMACEUTICALS   (United States)

^c NONE   (United States)

Author keywords

Accuracy; Bioanalytical; Precision; Reproducibilty; Sensitivity; Validation

Indexed keywords

ACCURACY; ANALYTIC METHOD; ARTICLE; CHROMATOGRAPHY; FOOD AND DRUG ADMINISTRATION; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY; THERMOSTABILITY; VALIDATION PROCESS; WORKSHOP; CALIBRATION; CHEMISTRY; METHODOLOGY; PHARMACEUTICS; QUALITY CONTROL; STANDARD;

DRUG;

BIOPHARMACEUTICS; CALIBRATION; CHEMISTRY, ANALYTICAL; CHROMATOGRAPHY; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 34247843033     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj0901011     Document Type: Article

References (2)

1. Food and Drug Administration. FDA Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2001.
2. Viswanathan CT, Bansal S, Booth B, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9:E30-E42.