Between-Batch Bioequivalence (BBE): a Statistical Test to Evaluate In Vitro Bioequivalence Considering the Between-Batch Variability.

ABSTRACT: Bioequivalence testing is an essential step during the development of generic drugs. Regulatory agencies have drafted recommendations and guidelines to frame this step but without finding any consensus. Different methodologies are applied depending on the geographical region. For instance, in the EU, EMA recommends using average bioequivalence test (ABE), while in the USA, FDA recommends using population bioequivalence (PBE) test. Both methods present some limitations (e.g., when batch variability is non-negligible) making it difficult to conclude to equivalence without subsequently increasing the sample size. This article proposes an alternative method to evaluate bioequivalence: between-batch bioequivalence (BBE). It is based on the comparison between the mean difference (Reference - Tes

SUBMITTER: Bodin J 

PROVIDER: S-EPMC7651657 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature