Author:
Arnold Mark E.,Booth Brian,King Lindsay,Ray Chad
Publisher
Springer Science and Business Media LLC
Reference15 articles.
1. FDA, US Department of Health and Human Services. Draft Guidance for Industry: Bioanalytical Method Validation (Revised). [Online] September 2013. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf .
2. Booth B, Arnold ME, DeSilva B, Amaravadi L, Dudal S, Fluhler E, et al. Workshop report: Crystal City V—quantitative bioanalytical method validation and implementation: the 2013 Revised FDA Guidance. AAPS J. 2015;17(2):277–88. doi: 10.1208/s12248-014-9696-2 .
3. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm Res. 1992;9(4):588–92.
4. Shah VP, Midha KK, Findlay JWA, Hill HM, Hulse JD, McGilveray IJ, et al. Bioanalytical method validation—a revisit with a decade of progress. Pharm Res. 2000;17(12):1151–557.
5. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailsted J, et al. Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9(1):E30–42.
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