Key elements of bioanalytical method validation for small molecules
Journal Title: The AAPS Journal - Year 2007, Vol 9, Issue 1
Abstract
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.
Authors and Affiliations
Surendra Bansal, Anthony DeStefano
Keywords
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- EP ID EP681579
- DOI 10.1208/aapsj0901011
- Views 104
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