Current issues in bioequivalence trials

In recent years, as more generic drug products became available, the quality, safety, and efficacy of generic drugs became a great concern. As a result, the assessment of bioequivalence between the generic drug products and the innovator product has become an important topic in drug development. This paper provides an overview of current regulatory requirements and unresolved scientific issues in the assessment of bioequivalence. These issues include three key statistical issues raised in the 1992 Food and Drug Administration (FDA) guidance, alternative decision rules and pharmacokinetic parameters, the use of female subjects, intrasubject variability and drug interchangeability, population and individual bioequivalence, in vitro dissolution as a surrogate for in vivo bioequivalence, pharmacodynamic measures, postapproval bioequivalence assessment, and international harmonization for bioequivalence requirements.

Duke Scholars

Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics