Bioequivalence

Step by Step Guide to Bioequivalence and Bioavailability Clinical Trials

The FDA has provided draft guidance for the industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations.” This document includes systematic guidance on how to conduct bioequivalence and bioavailability (BABE) clinical trials for submission of INDs and NDAs.   Regulatory bodies define bioavailability as the rate and extent to which an active ingredient […]

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