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Related Experiment Videos

Bioequivalence: switchability and scaling

K K Midha1, M J Rawson, J W Hubbard

  • 1Drug Metabolism, Drug Disposition Research Group, College of Pharmacy and Nutrition, Saskatoon, SK, S7N 5C9, Canada.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|October 31, 1998
PubMed
Summary

Bioequivalence between multisource drugs and a reference product does not ensure they are bioequivalent to each other. Scaling bioequivalence limits (BEL) is crucial for ensuring drug switchability, especially for toxic or highly variable drugs.

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Bioequivalence Studies
  • Regulatory Science

Background:

  • Current bioequivalence limits (BEL) may not adequately ensure interchangeability between multisource drug products.
  • Unscaled BEL permit greater deviation for low-variability drugs compared to high-variability drugs.

Purpose of the Study:

  • To evaluate the impact of scaling bioequivalence limits on ensuring interchangeability of multisource drug formulations.
  • To assess the suitability of scaled BEL for different drug variabilities and therapeutic indices.

Main Methods:

  • Analysis of geometric mean ratio (GMR) deviations under scaled and unscaled bioequivalence limits.
  • Comparison of bioequivalence outcomes for formulations with varying within-subject variabilities.

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Main Results:

  • Scaling bioequivalence limits significantly reduces GMR deviation for multisource drugs bioequivalent to the same reference.
  • Scaled BEL broaden limits for highly variable drugs, enhancing switchability.
  • Unscaled limits allow greater deviation for low-variability drugs, potentially compromising interchangeability.

Conclusions:

  • Scaling bioequivalence limits is essential for ensuring drug switchability, particularly for toxic, low-variability drugs and safe, highly variable drugs.
  • Scaling may not be necessary for safe, low-variability drugs.
  • Scaling should be avoided for highly variable drugs with narrow therapeutic ranges.