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Assessment of bioequivalence using a multiplicative model.

S C Chow1, K E Peace, J Shao

  • 1Biostatistics Department, Bristol-Myers Squibb Company, Plainsboro, New Jersey 08536.

Journal of Biopharmaceutical Statistics
|January 1, 1991
PubMed
Summary

This study proposes a new method using individual subject ratios to assess bioequivalence, particularly for skewed data common in bioavailability studies. This approach offers an alternative to logarithmic transformations for analyzing drug formulation comparisons.

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Area of Science:

  • Pharmacokinetics and Biopharmaceutics
  • Statistical Methods in Clinical Trials

Background:

  • Bioavailability and bioequivalence studies often face challenges with positively skewed response data (e.g., AUC, Cmax).
  • Standard methods frequently employ logarithmic transformations to address skewness and achieve homogeneous variances, assuming an additive model.

Purpose of the Study:

  • To introduce and evaluate a novel method for assessing bioequivalence based on a multiplicative model.
  • To provide an alternative approach for analyzing skewed pharmacokinetic data in formulation comparisons.

Main Methods:

  • Development of a bioequivalence assessment method utilizing individual subject ratios.
  • Application and extension of the proposed method to common crossover study designs.

Main Results:

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  • The proposed method offers a viable alternative for analyzing data that does not meet the assumptions of traditional transformations.
  • Empirical evidence supports the use of a multiplicative model in specific bioequivalence scenarios.

Conclusions:

  • Individual subject ratios provide a robust approach for bioequivalence assessment, especially when data exhibit skewness and heterogeneous variances.
  • The method is adaptable to various crossover designs, enhancing its practical utility in pharmaceutical research.