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Dermatologic bioequivalence

Executive Summary

Bioequivalence for topical dermatological drug products will be discussed by FDA's Pharmaceutical Science Advisory Committee March 12. The agency had issued a draft guidance on dermatopharmacokinetics, but is now considering alternatives (1"The Pink Sheet" Dec. 17, 2001, p. 40). Process Analytical Technologies Subcommittee's final report will also be presented, and the new Manufacturing, Biopharmaceutics and Microbiology subcommittees will be discussed...

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