Docket Number: FDA-2023-D-0093 Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies 4 during both development and post approval phases for orally administered immediate-release (IR) 5 solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, 6 capsules, and granules/powders for oral suspension.
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Content current as of:
10/30/2024
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