How Pitfalls during Drug Quantitation by Mass Spectrometry May Affect the Variability of Pharmacokinetic Data during a Bioequivalence Trial

Abstract

The majority of the time, during the performance of a bioequivalence trial, clinicians exercise extreme care in the selection of volunteers in order to obtain a homogeneous population, and control several sources of variation, such as diet, fasting period, hydration, and drug administration (among others), to the extent possible, to limit interand intra-individual variability and to achieve the statistical power required for the assay. In addition, monitoring staffs is charged with guaranteeing compliance with good clinical practices [1].