Open Discussion Forum
ICH M13 Bioequivalence Guideline Part A
the draft of the ICH M13 Bioequivalence Guideline part A has been released for consultation in December 2022 on the ICH website. EMA published this draft later (February 7, 2023) and thus, the consultation phase for Europe was extended and set to May 26, 2023.
The scientific community is now invited to submit comments to the suggested regulations. There are some modifications in bioequivalence (BE) requirements, relevant for European companies which should initiate comprehensive scientific discussion. Examples are, amongst others, the proposed regulations on fed and fasting study conditions, the selection of the comparator product, the proposed regulations on fed and fasting study conditions, measurement of metabolites for BE assessment, “early exposure” and partial AUC as PK characteristics, multiple test resp. comparator products, or drugs with pH-dependent solubility.
The intention of this conference is to give scientists from industry and academia the opportunity to discuss the new regulations with European representatives of the ICH-Guideline’s drafting group. It will be organised as an “Open Discussion Forum” based on comments submitted to the organisers in the run-up phase to the event. Moreover, all participants are invited to present their views and suggestions, based on own experience, during the discussion and support these proposals by experimental data.
The Open Discussion Forum will take place on Monday, May 15, 2023 from 10:00 am until 16:30 pm.
Hope to meet you in Frankfurt on May 15
Prof. Dr. Erem Bilensoy, Conference Chair
Prof. Dr. Sandra Klein, Conference Co-Chair