ArticleEuropean journal of drug metabolism and pharmacokinetics2025
Regulation for the Bioequivalence Evaluation of Generic Topical Dermatological Drug Products in Japan.
Article in European journal of drug metabolism and pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Use of Benzene-Free Carbomer 980 in the Formulation of Metronidazole Gel 0.75% and Demonstration of Equivalence with Carbomer 940.AAPS PharmSciTech · 2026Article
- Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan's 2025 Guidelines.Therapeutic innovation & regulatory science · 2026Review
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Authors and funding
3 authors.
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Abstract
BACKGROUND AND
objectiveIn Japan, the "Guideline for Bioequivalence (BE) Studies of Generic Products for Topical Use" was issued in 2003 to present the basic principles for BE evaluation methods for generic topical dermatological drug products. However, a detailed analysis of trends in BE evaluation methods in Japan has not yet been reported. In addition, a detailed comparison of the BE evaluation methods used at the Pharmaceuticals and Medical Devices Agency (PMDA), the US Food and Drug Administration (US FDA), and the European Medicines Agency (EMA) has also not been performed.
methodsWe surveyed BE evaluation methods for generic topical dermatological drug products in Japan based on the PMDA website from 2000 to 2023. We also compiled the latest guideline information for the PMDA, US FDA, and EMA.
resultsBefore the guideline was issued from 2000 to 2003, most generic topical dermatological drug products were evaluated using pharmacological tests in animals. After the guideline was issued in 2003, dermato-pharmacokinetic studies have become the main method for BE evaluation other than antiseptics in Japan. The greatest difference between the US FDA and EMA versus current Japanese regulations was the introduction of a biowaiver approach based on Q1/Q2 and Q3 similarities and in vitro test equivalence.
conclusionThis finding confirmed that the publication of the guideline significantly influenced the BE evaluation methods for topical dermatological drug products in Japan. Furthermore, Japan may consider a biowaiver approach based on Q1/Q2 and Q3 similarity and in vitro test equivalence.
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