The International Council for Harmonisation (ICH) is expected to adopt its M13A guideline on bioequivalence (BE) testing of immediate-release (IR) solid oral dosage form drugs this summer, announced Lei Zhang, of the US Food and Drug Administration (FDA) and the rapporteur of the M13A Expert Working Group, at the PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative meeting held on 16 April.
The ICH guideline, which also covers evaluating BE after postapproval changes, was released as a Step 2 document for consultation in December 2022 and represents a major advancement in how BE testing is conducted for immediate-release solid oral dosage forms. (RELATED: ICH releases draft guideline proposing harmonized bioequivalence testing, Regulatory Focus 3 January 2023)…
