DISSOLUTION TESTING CAN BE USED IN LIEU OF BIOEQUIVALENCE TESTING WHEN IN VITRO/IN VIVO CORRELATION HAS BEEN SHOWN -- GENERIC DRUGS ADVISORY COMMITTEE
Executive Summary
Dissolution tests can be used in place of bioequivalence tests for minor changes to extended-release drug formulations when an in vitro/in vivo correlation (IVIVC) has been shown to exist, FDA's Generic Drugs Advisory Committee agreed during the second day of its Jan. 11-12 meeting.