DISSOLUTION TESTING CAN BE USED IN LIEU OF BIOEQUIVALENCE TESTING WHEN IN VITRO/IN VIVO CORRELATION HAS BEEN SHOWN -- GENERIC DRUGS ADVISORY COMMITTEE
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth