title: Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products.
abstract: The pharmacokinetic approach has accelerated the development of high-quality generic medicines with extraordinary cost savings, transforming the pharmaceutical industry and healthcare system in the USA. While this is true for systemically absorbed drug products, the availability of generic versions of topical dermatological products remains constrained due to the limited methods accepted for bioequivalence evaluation of these products. The current review explores the possibility of developing appropriate bioequivalence approaches based on pharmacokinetic principles for topical dermatological products. This review focuses on the strengths and limitations of the three most promising pharmacokinetics-based methods to evaluate the performance and bioequivalence of topical dermatological products, which include in vivo skin stripping, in vivo microdialysis, and in vitro permeation testing (IVPT) with excised human skin. It is hoped that recent advances in pharmaceutical and regulatory science will facilitate the development of robust bioequivalence approaches for these dosage forms, enable more efficient methodologies to compare the performance of new drug products in certain pre-approval or post-approval change situations, and promote the availability of high-quality generic versions of topical dermatological products.
authors.affiliation: Office of Research and Standards, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Sameersingh.Raney@fda.hhs.gov.
authors.forename: Sam G
authors.initials: SG
authors.lastname: Raney
authors.affiliation: , 10716 SE Forest View Lane, Happy Valley, OR, 97086, USA.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Franz
authors.affiliation: QPS Holdings, LLC, Newark, DE, USA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Lehman
authors.affiliation: Office of Research and Standards, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Lionberger
authors.affiliation: Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Mei-Ling
authors.initials: ML
authors.lastname: Chen
mesh_terms: D000287:Administration, Topical; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D066298:In Vitro Techniques; D012867:Skin / Q000187:drug effects* / Q000378:metabolism; D012869:Skin Absorption / Q000187:drug effects; D013810:Therapeutic Equivalency
chemical_list: D003879:Dermatologic Agents