For all of you dealing with BE of IR products:
The International Council for Harmonisation finalized its guideline M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms on July 23, 2024. It is accompanied by a Q&A document. The implementation of the guideline will take some time. There is no deadline and no obligation for an agency to implement it at all. However, it is expected to supersede current guidelines at least in the major jurisdictions (FDA, EMA).
For some differences to the draft guideline (December 20, 2022) see this thread in the BEBA-Forum.
