Validation and Control of Bioanalytical Methods

Chapter
Part of the Cancer Drug Discovery and Development book series (CDD&D)

Abstract

The results of toxicokinetic, pharmacokinetic, and bioequivalence studies are used to make critical decisions regarding the safety and efficacy of anticancer drug substances. Therefore, measurement of anticancer drug concentrations in biological matrices is an important aspect in the development of these products. Such data are required by regulating agencies to support new drug applications as well as for line extensions and generic products of these drugs. It is therefore most essential to adequately characterize and fully validate the applied bioanalytical methods used in the determination of this class of compounds to ensure that they function in the manner in which they are intended. Since the release of the FDA prescribed Guidance for Industry in Bioanalytical Method Validation in May 2001, it is much clearer what is required for method validation. There are however a number of areas that are still not well developed in the FDA guidance, and the recently proposed draft European Medical Agency guidance addresses some of these. Apart from discussing acceptance criteria on the primary matrices required to determine bioanalytical assay suitability such as accuracy, precision, and selectivity, the draft guidance proposes additional criteria for other important aspects such stability tests, matrix effects, cross validation, and incurred sample reanalysis. The current chapter provides an overview of the current scientific approaches based on the literature while considering them in the context of these guidances in this highly regulated area.

Keywords

Bioanalysis Method validation Acceptance criteria Quality control 

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  1. 1.Department of PharmaceuticsVirginia Commonwealth University School of PharmacyRichmondUSA
  2. 2.Research Scientist R&D, Chromatographic Sciences Department, PPDRichmondUSA

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