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This chapter presents the development of a statistical model designed to evaluate the bioequivalence (BE) of topical dermatological dosage forms using data from In Vitro Permeation Test (IVPT) studies. The proposed scaling model demonstrates the capability to detect significant differences between a prospective generic (test) product and a reference standard (RS) product, featuring greater sensitivity compared to unscaled tests. Additionally, it requires smaller sample sizes to achieve adequate statistical power. Initially outlined in the FDA’s 2016 guidance on Acyclovir cream, this statistical method has since been refined and expanded to address unbalanced datasets, as detailed in the FDA’s draft guidance on IVPT studies for topical drug products released in October 2022.

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A Statistical Approach for Establishing Bioequivalence in Topical Dermatological Drug Products Using the In Vitro Permeation Test

  • 章节

  • 发表日期：

    2025年

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  • Elena Rantou,
  • Nam Hee Choi,
  • Donald Schuirmann,
  • Stella Grosser

摘要

This chapter presents the development of a statistical model designed to evaluate the bioequivalence (BE) of topical dermatological dosage forms using data from In Vitro Permeation Test (IVPT) studies. The proposed scaling model demonstrates the capability to detect significant differences between a prospective generic (test) product and a reference standard (RS) product, featuring greater sensitivity compared to unscaled tests. Additionally, it requires smaller sample sizes to achieve adequate statistical power. Initially outlined in the FDA’s 2016 guidance on Acyclovir cream, this statistical method has since been refined and expanded to address unbalanced datasets, as detailed in the FDA’s draft guidance on IVPT studies for topical drug products released in October 2022.