REFERENCE TABLES FOR THE INTRASUBJECT COEFFICIENT OF VARIATION IN BIOEQUIVALENCE STUDIES

Bioequivalence studies are usually performed as crossover studies and, therefore, information on the intrasubject coefficient of variation i s needed for sample size planning, However, this information is usuall y not accessible in publications on bioequivalence studies, and only t he pooled inter- and intrasubject coefficient of variation for either test or reference formulation is reported. It is the purpose of the pr esent communication to provide reference values of the intrasubject co efficient of variation for various previously investigated drugs. The presentation includes pertinent pharmacokinetic characteristics for im mediate- and extended-release formulations in single- and multiple-dos e crossover studies.