The global bioequivalence harmonisation initiative: Report of EUFEPS/AAPS third conference

The European Federation of Pharmaceutical Sciences (EUFEPS) and American Association of Pharmaceutical Scientists (AAPS) have collaborated since 2015 to organize international conferences to support global monization of regulatory requirements for bioequivalence (BE) assessment. This collaboration has resulted three Global Bioequivalence Harmonization Initiative (GBHI) workshops which provided a unique opportunity for scientists from academia, industry, and regulatory agencies to discuss current, complex BE issues. The GBHI workshop was held in April 2018 in Amsterdam/The Netherlands and covered the following topics: (a) necessity of multiple -dose studies in BE testing; (b) BE of transdermal delivery systems, and (c) liposomal parenteral preparations. This report summarizes the extensive discussions that led to better understanding of similarities and di fferences across the major regulatory agencies on these topics and paved the way for future international harmonization.