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Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One‑Sided t‑Tests

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The traditional two one-sided t-tests (TOST) for bioequivalence (BE) may be overly conservative with extreme data. A Bayesian alternative (BayesT) offers more reliable BE assessments, especially when data deviates from lognormality.

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Area of Science:

  • Pharmacokinetics and Biopharmaceutics
  • Statistical Methods in Drug Development
  • Regulatory Science

Background:

  • The two one-sided t-tests (TOST) is the standard statistical method for evaluating average bioequivalence (BE).
  • Regulatory assessments of generic drugs, formulation bridging, and 505b2 drug comparisons rely on BE evaluations.
  • Deviations from lognormality and extreme values can impact the reliability of TOST for BE determination.

Purpose of the Study:

  • To compare the performance of TOST and a Bayesian procedure (BayesT) for bioequivalence assessment.
  • To evaluate the influence of deviations from lognormality and extreme values on BE determinations.
  • To assess the reliability of statistical inference procedures for accurate and fair regulatory assessments of bioequivalence and non-bioequivalence.

Main Methods:

  • A comparative analysis of TOST and a t-distribution-based Bayesian procedure (BayesT) was performed.
  • 2341 pharmacokinetic parameter datasets from 678 anonymized abbreviated new drug applications (ANDAs) were analyzed.
  • The BE criterion for both methods was 90% confidence (CI) or Bayesian credible (CrI) intervals of log test/reference ratios between 0.80-1.25.

Main Results:

  • TOST and BayesT agreed on BE conclusions in 98.9% of the analyzed datasets.
  • In 20 disagreed cases, TOST rejected BE while BayesT concluded BE, with all failing lognormality and 17 containing extreme values.
  • TOST can be overly conservative with extreme values, and deviations from lognormality may lead to faulty BE inference.

Conclusions:

  • The Bayesian methodology (BayesT) provides a reliable alternative to TOST for bioequivalence assessment.
  • BayesT can offer more robust outcomes in scenarios with deviations from lognormality and extreme values.
  • Prespecified application of BayesT may enhance the reliability of regulatory assessments for bioequivalence.