论文信息 - The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation

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

Bioanalytical method validation (BMV) employed for the quantitative determination of drugs and their metabolites in biological fl uids plays a signifi cant role in the evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic study data. These studies generally support regulatory fi lings. The quality of these studies is directly related to the quality of the underlying bioanalytical data. It is therefore important that guiding principles for the validation of these analytical methods be established and disseminated to the pharmaceutical community. This chapter provides historical perspectives in the evolution and development of the BMV guidance. This guidance, virtually in one form or another, has been adopted universally as a standard procedure for validating bioanalytical assays used for pharmacokinetic, bioavailability, and bioequivalence studies intended for regulatory submission.

Vinod P. Shah | V. Shah

[1] Vinod P. Shah,et al. Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays , 2007 .

[2] Vinod P. Shah,et al. Bioanalytical Method Validation—A Revisit with a Decade of Progress , 2000, Pharmaceutical Research.

[3] A Yacobi,et al. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies , 1991, European Journal of Drug Metabolism and Pharmacokinetics.

[4] Thomas Layloff,et al. Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies , 1992, Pharmaceutical Research.

[5] Vinod P. Shah,et al. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007 .