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Related Experiment Videos

Bridging bioequivalence studies.

Jen-pei Liu1

  • 1Department of Agronomy, National Taiwan University, Taipei, Taiwan. jpliu@ntu.edu.tw

Journal of Biopharmaceutical Statistics
|December 14, 2004
PubMed
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This study proposes a method to assess bioequivalence for local generic drugs in new regions, using an original generic drug as a bridge. This approach supports regulatory approval when the innovative drug is unavailable.

Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Pharmacokinetics

Background:

  • Innovative drugs may not be marketed in new regions before patent expiry.
  • Generic versions from the original region can be approved, but local generic drugs also seek market entry.
  • Regulatory authorities need methods to approve local generics based on bioequivalence, even without the innovative drug.

Purpose of the Study:

  • To propose a method for evaluating average bioequivalence between a local generic drug and an innovative drug from an original region.
  • To utilize the original region's generic copy as a bridging reference formulation.
  • To provide sample size calculations for bioequivalence studies in new regions.

Main Methods:

  • Application of the bridging concept from ICH E5 guidance.

Related Experiment Videos

  • Establishing bioequivalence between the new region's generic and the original region's generic.
  • Using the original region's generic as a reference to bridge to the innovative drug.
  • Calculating required sample sizes for the bioequivalence study.

    • Main Results:

    • A validated method for assessing average bioequivalence is presented.
    • The proposed method effectively uses a bridging reference formulation.
    • Sample size estimations are provided for practical application.

    Conclusions:

    • The proposed method facilitates the approval of local generic drugs in new regions.
    • This approach supports regulatory decision-making by bridging bioequivalence data.
    • The study provides a framework for global drug regulatory harmonization.