The International Council for Harmonisation has proposed standardized bioequivalence study requirements for immediate-release 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 these oral dosage forms to establish therapeutic equivalence of the generic versions with their respective comparator products
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