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Critical Remarks on Reference-Scaled Average Bioequivalence.

Helmut Schütz1, Detlew Labes2, Martin J Wolfsegger3

  • 1BEBAC, Consultancy Services for Bioequivalence and Bioavailability Studies.

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PubMed
Summary
This summary is machine-generated.

Regulatory methods for highly variable drugs can inflate consumer risk. Average bioequivalence with widened limits is recommended, or adjusting the test level alpha, to ensure drug safety and consistency.

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Biostatistics

Background:

  • Reference-scaled average bioequivalence (RSAE) is used for highly variable drugs.
  • Current regulatory approaches vary by jurisdiction and may yield inconsistent conclusions.
  • Operating characteristics of implemented RSAE methods have not been directly compared.

Purpose of the Study:

  • To compare the operating characteristics of different RSAE methods.
  • To assess consumer risk and clinically relevant differences under regulatory settings.
  • To evaluate the impact of varying jurisdictional approaches on bioequivalence assessment.

Main Methods:

  • Monte Carlo simulations were employed.
  • Simulations assessed Type I Error and statistical power.
  • Consumer risk and clinically relevant differences were evaluated.

Main Results:

  • All RSAE methods showed potential for Type I Error inflation.
  • Consumer risk was compromised in implemented RSAE methods.
  • Clinically relevant differences varied across studies using the same reference product.

Conclusions:

  • Average bioequivalence with fixed, widened limits ensures consumer risk and defines a clear clinically non-relevant difference.
  • Until fixed limits are adopted, adjusting the test level alpha is recommended.
  • Standardized approaches are needed for consistent bioequivalence assessment of highly variable drugs.