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

Abstract

I NTRODUCTION Bioanalysis, 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 bioequivalence, pharmacokinetic (PK), and toxicokinetic studies. The quality of these studies, which are often used to support regulatory fi lings, 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. The fi rst American Association of Pharmaceutical Scientists (AAPS)/Food and Drug Administration (FDA) Bioanalytical Workshop in 1990 focused on key issues relevant to bioanalytical methodology and provided a platform for scientifi c discussions and deliberations. The workshop and the report 1 raised awareness of the need for validated bioanalytical methods for the regulatory acceptance of bioequivalence and pharmacokinetic data. Although the workshop addressed bioanalysis in general, it acknowledged the differences between chromatographic and ligand binding (nonchromatographic based) methods. The workshop identifi ed the essential parameters for bioanalytical method validation, ie, accuracy, precision, selectivity, sensitivity, reproducibility, limit of detection, and stability. The outcome of the fi rst workshop and its report resulted in improved quality of data submissions to regulatory agencies. Following the fi rst workshop report 1 and the experience