EMA/ICH - The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been adopted
Year: 2024
Type: other
Abstract: The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been fully adopted on 23 July 2024. This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post-approval phases for orally administered immediate-release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. Deviations from the recommendation...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12j9d
Author: Vroby
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6936548885
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