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Progress in methodologies for evaluating bioequivalence of topical formulations
1Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA.
American Journal of Clinical Dermatology
|November 28, 2001
Summary
Determining bioequivalence for topical dermatological products is challenging. Dermatopharmacokinetics, measuring drug levels in the stratum corneum via tape stripping, offers a reliable in vivo method for assessing bioequivalence of all topical formulations.
Area of Science:
- Dermatology
- Pharmacokinetics
- Drug delivery systems
Background:
- Assessing bioequivalence for topical dermatological formulations presents significant challenges.
- Current methods primarily rely on comparative clinical studies, with exceptions for corticosteroids.
Purpose of the Study:
- To review in vivo methodologies for establishing bioequivalence of topical dermatological formulations.
- To highlight the progress and potential of dermatopharmacokinetics in this field.
Main Methods:
- Review of existing literature on in vivo bioequivalence studies for topical drugs.
- Focus on dermatopharmacokinetics, specifically the tape stripping procedure.
- Analysis of drug concentration in the stratum corneum at the application site.
Main Results:
- Dermatopharmacokinetics is identified as a reliable and reproducible in vivo method.
- The tape stripping procedure within dermatopharmacokinetics measures drug concentration in the stratum corneum.
- This methodology shows applicability for all topical dermatological drug products.
Conclusions:
- Dermatopharmacokinetics offers a promising alternative to traditional clinical studies for topical formulation bioequivalence.
- Further validation is needed to build confidence in its correlation with clinical drug efficacy.