Key elements of bioanalytical method validation for small molecules.
Method validation is a process that demonstrates that a method will successfully meet or exceed the minimum standards recommended in the Food and Drug Administration (FDA) guidance for accuracy, precision, selectivity, sensitivity, reproducibility, and stability. This article discusses the validation of bioanalytical methods for small molecules with emphasis on chromatographic techniques. We present current thinking on validation requirements as described in the current FDA Guidance and subsequent 2006 Bioanalytical Methods Validation Workshop white paper.
Bansal
Surendra
S
Hoffman-LaRoche Inc, Nutley, NJ, USA. Surendra.bansal@roche.com
DeStefano
Anthony
A
D001702:Biopharmaceutics / Q000379:methods* / Q000592:standards; D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D002845:Chromatography / Q000379:methods / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D004364:Pharmaceutical Preparations