The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.
The International Council for Harmonisation has proposed standardized bioequivalence (BE) study requirements for immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules and granules/powders for oral suspension.
The draft ICH M13A guideline was keenly awaited by generic drug manufacturers, who need to undertake BE assessments for...
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