Chapter 16 - Bioanalytical method validation and bioanalysis in regulated settings

Abstract

The regulated bioanalysis is governed by Good Laboratory Practices, Good Clinical Practices, the Food and Drug Administration's “Guidance for Industry”, and the European Medicine Agency's “Guidance on Method Validation”. Numerous conference reports, position papers, other publications, and local industrial practices set secondary rules. This chapter describes the principles of bioanalytical method validation, sample analysis, documentation, and reporting which are up to regulatory and industrial standards as of fall 2012 for the chromatographic techniques. In addition to the most basic parameters of bioanalytical methods, the authors critically evaluate other factors which so far have not been sufficiently exposed: different matrix effects, regression selection, analysis in hemolyzed and lipidemic plasma, alternative acceptance criteria, analyses of blood samples, tissues, and homogenates, and internal standard consistency. Validation and sample analysis by emerging technologies like dried blood spot, high-resolution mass spectrometry, and analysis of therapeutic proteins are also discussed.