FDA May Consider DPK Alternatives Following Advisory Committee Meeting
Executive Summary
FDA is considering evaluating alternatives to dermatopharmacokinetics for determining bioequivalence of topical dermatological products
You may also be interested in...
Dermatologic bioequivalence
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 The agency had issued a draft guidance on dermatopharmacokinetics, but is now considering alternatives (1"The Pink Sheet" Dec. 17, 2001, p. 40).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...
Dermatologic bioequivalence
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 The agency had issued a draft guidance on dermatopharmacokinetics, but is now considering alternatives (1"The Pink Sheet" Dec. 17, 2001, p. 40).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...
DPK guidance to be withdrawn
FDA will withdraw draft guidance on dermatopharmacokinetics. "We are going to focus on a variety of other methods that make it possible for bioequivalence" for topical dermatologic products, Office of Pharmaceutical Science Acting Director Helen Winkle told the Generic Pharmaceutical Association's annual meeting in Coral Gables, Fla., April 10. "This is not to say that DPK is completely off the radar screen - we will continue to look at it - but we felt like we wanted to get the guidance out of publication." The agency has been considering alternatives following an unfavorable advisory committee meeting (1"The Pink Sheet" Dec. 17, 2001, p. 40)...