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Bioanalytical Method Validation—A Revisit with a Decade of Progress

Pharmaceutical Research · 2000 · Vol. 17(12) · pp. 1551–1557

Vinod P. Shah✉(Center for Drug Evaluation and Research)Kamal K. Midha(University of Saskatchewan)John W. A. FindlayHoward HillJames D. Hulse(Harris Health System)Iain J. McGilverayGordon McKay(University of Saskatchewan)Krys J. Miller(Amgen (United States))Rabindra Patnaik(Food and Drug Administration)Mark L. Powell(Bristol-Myers Squibb (Germany))Alfred Tonelli(Purdue Pharma (Canada))C.T. Viswanathan(Center for Drug Evaluation and Research)Avraham Yacobi(Taro Pharmaceuticals (United States))

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Biosimilars and Bioanalytical Methods Biotin and Related Studies Advanced Biosensing Techniques and ApplicationsBioanalysisData scienceComputer scienceComputational biologyNanotechnologyBiochemical engineeringEngineering ethicsBiologyEngineeringMaterials science

MeSH terms

Biological AssayBiological AvailabilityPharmaceutical PreparationsIndicators and ReagentsPharmacokineticsTherapeutic EquivalencyReproducibility of Results

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