The Food and Drug Administration (FDA), Center for Drug Evaluation Research (CDER) has a requirement to develop an improved skin stripping methodology for studying dermatopharmacokinetics of topical products in the stratum corneum of human subjects and to demonstrate its utility in establishing equivalence. This will provide the basis for a new bioequivalence guidance for topical anti-fungal products. The duration of this project will be 1.5 years. RFQ available on or around August 5, 2003.
Bid Protests Not Available