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Related Experiment Videos

Individual bioequivalence--has its time come?

L Endrenyi1, K K Midha

  • 1University of Toronto, Department of Pharmacology, and Department of Preventive Medicine and Biostatistics, Toronto Ont. M5S 1A8, Canada. l.endrenyi@utoronto.ca

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|October 31, 1998
PubMed
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The Food and Drug Administration (FDA) is updating bioequivalence assessment from average to individual bioequivalence. This new approach requires 4-period crossover trials to evaluate intraindividual variances and subject-formulation interactions.

Area of Science:

  • Pharmacokinetics and Drug Development
  • Regulatory Science
  • Biostatistics

Background:

  • The current FDA framework for bioequivalence assessment relies on average kinetic response comparisons.
  • A new draft Guidance proposes a shift towards individual bioequivalence evaluation.
  • This transition necessitates a re-evaluation of bioequivalence trial designs and statistical methods.

Purpose of the Study:

  • To describe the rationale, principles, and procedures of the proposed individual bioequivalence approach.
  • To facilitate discussion and understanding of the forthcoming FDA draft Guidance.
  • To identify and raise open questions requiring further research and expert consensus.

Main Methods:

  • The study outlines the principles of individual bioequivalence, contrasting it with the average bioequivalence approach.

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  • It details the statistical considerations, emphasizing intraindividual variances and subject-formulation interactions.
  • The requirement for 4- (or 3-) period crossover bioequivalence trials is highlighted.

    • Main Results:

    • The draft Guidance introduces a novel framework for bioequivalence assessment.
    • The new approach focuses on individual variability and subject-formulation interactions.
    • Specific trial designs, such as 4-period crossover studies, are mandated.

    Conclusions:

    • The proposed individual bioequivalence approach represents a significant departure from current practices.
    • Extensive discussion and further research are crucial for addressing open questions.
    • More experience is needed before the potential implementation of this new regulatory framework.