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Review
. 2022 Jul;40(3):319-332.
doi: 10.1016/j.det.2022.02.007.

Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products

Sam G Raney  1 , Priyanka Ghosh  2 , Tannaz Ramezanli  2 , Paul A Lehman  3 , Thomas J Franz  4
Affiliations
Review

Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products

Sam G Raney et al. Dermatol Clin. 2022 Jul.

Abstract

The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Several test methods have been discussed and developed to evaluate topical bioavailability (BA) and BE. Pharmacokinetics-based approaches characterize the rate and extent to which an active ingredient becomes available at or near its site of action in the skin. Such methodologies are considered to be among the most accurate, sensitive, and reproducible approaches for determining the BA or BE of a product.

Keywords: Bioequivalence; Dermatologic; Generics; Pharmacokinetics; Topical.

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Conflict of interest statement

Disclosure The information and opinions expressed in this article reflect the views of the authors and do not necessarily reflect the views or policies of the FDA or any other organizations with which the authors are affiliated.

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