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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. doi: 10.1023/A:1015829422034. [DOI] [PubMed] [Google Scholar]
- 2.Food and Drug Administration . Draft Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: US Food and Drug Administration; 1999. [Google Scholar]
- 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. doi: 10.1023/A:1007669411738. [DOI] [PubMed] [Google Scholar]
- 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. [Google Scholar]
- 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. [DOI] [PubMed]