AUTHOR=Fernandes Eduardo Agostinho Freitas , Oudtshoorn Joy van , Tam Andrew , González Liliana Carolina Arévalo , Aurela Erwin Guzmán , Potthast Henrike , Mettke Katalina , Kuribayashi Ryosuke , Shimojo Kohei , Kasuga Miho , Morales Lázaro , Rodríguez Zulema , Jones Ben , Ahn Choongyul , Yun Eunju , Kim So Hee , Rodrigues Clare , Tiong Toh , Crane Christopher , Walther Chantal , Roost Matthias S. , Chen Tzu-Ling , Hsu Li-feng , Braddy April C. , García-Arieta Alfredo , Abalos Ivana , Divinsky Milly , Alsuwyeh Abdulaziz , Alzenaidy Bader , Alharf Adel TITLE=The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities JOURNAL=Journal of Pharmacy & Pharmaceutical Sciences VOLUME=27 YEAR=2024 URL=https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2024.12398 DOI=10.3389/jpps.2024.12398 ISSN=1482-1826 ABSTRACT=

Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the recommendations from participating Bioequivalence Working Group for Generics (BEWGG) members of the International Pharmaceutical Regulators Programme (IPRP) regarding the conduct and acceptance criteria for BE studies of immediate release solid oral dosage forms. A survey was conducted among BEWGG members regarding their BE recommendations and requirements related to study subjects, study design, sample size, single or multiple dose administration, study conditions (fasting or fed), analyte to be measured, selection of product strength, drug content, handling of endogenous substances, BE acceptance criteria, and additional design aspects. All members prefer conducting single dose cross-over designed studies in healthy subjects with a minimum of 12 subjects and utilizing the parent drug data to assess BE. However, differences emerged among the members when the drug’s pharmacokinetics and pharmacodynamics become more complex, such that the study design (e.g., fasting versus fed conditions) and BE acceptance criteria (e.g., highly variable drugs, narrow therapeutic index drugs) may be affected. The survey results and discussions were shared with the ICH M13 Expert Working Group (EWG) and played an important role in identifying and analyzing gaps during the harmonization process. The draft ICH M13A guideline developed by the M13 EWG was endorsed by ICH on 20 December 2022, under Step 2.