TRETINOIN BIOEQUIVALENCE PILOT STUDIES BASED ON WATER LOSS
TRETINOIN BIOEQUIVALENCE PILOT STUDIES BASED ON WATER LOSS and days-to-skin peeling surrogate end-points were introduced at FDA's Generic Drugs Advisory Committee meeting Sept. 13. FDA's Dermatological Drags Advisory Committee was also represented. Division of Topical Drugs Products Medical Officer Thomas Franz, MD, said the studies measure skin absorption of retinoic acid cream formulations at concentrations of .025%, .05% and .1% compared to placebo and innovator creams.
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