European Journal of Pharmaceutical Sciences 1 September 2025

Title	European Journal of Pharmaceutical Sciences 1 September 2025
Edition	1 September 2025
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ISBN/ISSN
Author(s)
Subject(s)	Bioequivalence Highly variable drug Modeling
Classification
Series Title
GMD	Jurnal
Language	Indonesia
Publisher
Publishing Year	2025
Publishing Place
Collation
Abstract/Notes	ABSTRACT At the 6th International Conference of the Global Bioequivalence Harmonisation Initiative (GBHI), co-organised by the European Federation of Pharmaceutical Sciences (EUFEPS) and the Product Quality Research Institute (PQRI), critical bioequivalence (BE) topics were discussed by pharmaceutical scientists from academia, industry and regulatory agencies, revealing the following main conclusions: (1) Physiologically based pharmacokinetic/biopharmaceutic modelling (PBPK/PBBM) for solid oral drugs: PBPK/PBBM gains increasing recognition for generic drug development, e.g. waivers of fed studies and drug interaction studies with proton pump inhibitors. However, especially for complex formulations containing low- solubility compounds, more data are needed for modelling-based conclusion regarding BE in fed state. (2) Narrow therapeutic index drugs: A progress towards harmonisation of BE criteria from US-FDA and EMA speakers was made as there is consensus in the usefulness of applying a mixed scale for BE acceptance range depending on variability, via either fully or partially replicated design. Differences still remain regarding vari- ability comparison and the selection of regulatory constant (0.760 vs. 1.05361). All parties confirmed the importance of controlling type-I error. (3) Single- vs. multiple-dose studies for BE demonstration of modified-release (MR) products: To circumvent multiple-dose studies, model-informed approaches were discussed based on real-life data, e.g. to simulate steady- state profiles from single-dose data. To reduce the burden in patient trials for long-acting injectables promising modelling approaches were presented, extrapolating from incomplete steady-state scenarios. (4) BE demonstration for additional dose strengths of solid oral MR products: For multiple-unit dosage forms where strengths differ in number of units only, testing BE of the highest dose was considered sufficient. In addition, there was some consensus that, whenever extrapolation from one strength to the others is not easily established, the “bracket-approach” of the EMA focusing on the intake conditions in the label claim (fasted or fed), can help mitigating risks without adding significant cost and effort.
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