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

Bioanalytical Method Validation—A Revisit with a Decade of Progress

Vinod P. Shah, Kamal K. Midha, John W. A. Findlay et al. · Pharmaceutical Research · 2000 · 1.6K citations

Pharmacy, Biochemistry, Analytical Chemistry +11

Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

C.T. Viswanathan, Surendra K. Bansal, Brian Booth et al. · Pharmaceutical Research · 2007 · 815 citations

Pharmacy, Biochemistry, Chemistry +16

Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies

Vinod P. Shah, K.K. Midha, S Dighe et al. · European Journal of Drug Metabolism and Pharmacokinetics · 1991 · 617 citations

Pharmacy, Pharmaceutics, Pharmacokinetics +14

Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

C.T. Viswanathan, Surendra K. Bansal, Brian Booth et al. · The AAPS Journal · 2007 · 483 citations · Full text

Pharmacy, Chemistry, Analytical Chemistry +13

Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe et al. · Pharmaceutical Research · 1992 · 446 citations

Pharmacy, Pharmaceutics, Pharmacokinetics +14