Dermatopharmacokinetics (DPK). Dale P. Conner, Pharm.D. Division of Bioequivalence Office of Generic Drugs, CDER, FDA. Background. Bioequivalence (BE) Current BE Methods for Topical Products. Definition of Bioequivalence.
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Dale P. Conner, Pharm.D.
Division of Bioequivalence
Office of Generic Drugs, CDER, FDA
Dosage Form Performance
BE Study with Clinical End-points
Insensitive to differences in formulation performance
BE Study with Pharmacodynamic End-points
Limited to only a few classes of compounds (glucocorticoids)
In Vitro Drug Release
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (www.fda.gov/cder/guidance/old098fn.pdf)