The AAPS Journal

, Volume 9, Issue 1, pp E109–E114 | Cite as

Key elements of bioanalytical method validation for small molecules

Article

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.

Keywords

bioanalytical validation precision accuracy sensitivity selectivity reproducibility 

References

  1. 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.Google Scholar
  2. 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.CrossRefGoogle Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2007

Authors and Affiliations

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

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