Drug metabolism studies should be completed prior to Phase III, agency guidance says.
DRUG METABOLISM STUDIES SHOULD BE COMPLETED PRIOR TO PHASE III, FDA states in a guidance for industry on "Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro" released on April 9. "An understanding of the metabolic profile of a drug in vitro would be useful prior to the initiation of Phase II studies and is especially important before Phase III trials," the guidance states. "Sponsors are encouraged to conduct appropriate metabolic studies prior to the commencement of Phase III trials."
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