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The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation

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References

  1. Shah VP, Midha KK, Dighe SV, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies.Pharm Res. 1992;9:588–592.

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  2. Food and Drug Administration.Draft Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: US Food and Drug Administration; 1999.

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  3. Shah VP, Midha KK, Findlay JW, et al. Bioanalytical method validation—a revisit with a decade of progress.Pharm Res. 2000;17:1551–1557.

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  4. Food and Drug Administration.Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; 2001.

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  5. 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: Article 4.

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Authors and Affiliations

  1. Pharmaceutical Consultant, 11309 Dunleith Place, 20878, North Potomac, MD

    Vinod P. Shah

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  1. Vinod P. Shah
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Correspondence to Vinod P. Shah.

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Published: February 16, 2007

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Shah, V.P. The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation. AAPS J 9, 5 (2007). https://doi.org/10.1208/aapsj0901005

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  • DOI: https://doi.org/10.1208/aapsj0901005

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