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Related Experiment Videos

The bootstrap procedure in individual bioequivalence.

J Shao1, S C Chow, B Wang

  • 1Department of Statistics, University of Wisconsin-Madison, 1210 West Dayton St., Madison, WI 53706-1685, USA.

Statistics in Medicine
|October 18, 2000
PubMed
Summary
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This study identifies flaws in the U.S. Food and Drug Administration's (FDA) proposed bootstrap test for drug bioequivalence, including incorrect computation and low power. Improved methods for assessing bioequivalence and determining sample size are proposed.

Area of Science:

  • Pharmacokinetics and Pharmaceutical Sciences
  • Biostatistics
  • Regulatory Science

Background:

  • The United States Food and Drug Administration (FDA) proposed a bootstrap-type hypothesis test for assessing bioequivalence between drug formulations.
  • Evaluating the statistical properties of this proposed test is crucial for accurate drug approval processes.

Purpose of the Study:

  • To investigate the unknown properties of the FDA's suggested bootstrap test for individual and population bioequivalence.
  • To propose improved statistical test procedures for bioequivalence assessment.
  • To address limitations in the FDA's draft guidance regarding bioequivalence testing.

Main Methods:

  • Analysis of the FDA's bootstrap computation for bioequivalence.
  • Evaluation of statistical power and size of different bootstrap test procedures.

Related Experiment Videos

  • Comparison of the REML method with simpler methods like the moment method.
  • Assessment of the FDA's sample size determination method.

    • Main Results:

    • The FDA's bootstrap computation for bioequivalence is identified as incorrect.
    • The statistical power of the FDA's proposed test can be significantly low.
    • The REML method offers no discernible advantage over simpler methods for this application.
    • The FDA's method for sample size determination is deemed inappropriate.
    • Alternative bootstrap test procedures were studied for their size and power characteristics.

    Conclusions:

    • The FDA's draft guidance for bioequivalence testing contains several statistical deficiencies.
    • Improved bootstrap test procedures and sample size determination methods are necessary.
    • Further research is needed to establish a satisfactory statistical method for assessing bioequivalence.