Bioequivalence testing is an essential step during the development of generic drugs. Different methodologies are used depending on the requirement. For e.g, in the EU, EMA recommends using average bio equivalence test (ABE), while in the USA, FDA recommends using population bio equivalence (PBE) test. Both methods present some limitations. alternatively Bodin et. al., AAPS journal 2020 proposed method to evaluate bio equivalence: between-batch bio equivalence (BBE). It is based on the comparison between the mean
difference (Reference − Test) and the Reference between-batch variability.