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

Author:

Shah Vinod P.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference5 articles.

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

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Draft Guidance for Industry: Bioanalytical Method Validation.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

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.

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.

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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