The AAPS Journal

, Volume 9, Issue 1, pp E109–E114

Key elements of bioanalytical method validation for small molecules


DOI: 10.1208/aapsj0901011

Cite this article as:
Bansal, S. & DeStefano, A. AAPS J (2007) 9: E109. doi:10.1208/aapsj0901011


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.


bioanalytical validation precision accuracy sensitivity selectivity reproducibility 

Copyright information

© American Association of Pharmaceutical Scientists 2007

Authors and Affiliations

  1. 1.Hoffman-LaRoche IncNutley
  2. 2.Procter & Gamble PharmaceuticalsMason

Personalised recommendations