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Finite sample corrections for average equivalence testing.

Younes Boulaguiem1, Julie Quartier2,3, Maria Lapteva2,3

  • 1Geneva School of Economics and Management, University of Geneva, Switzerland.

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|December 20, 2023
PubMed
Summary
This summary is machine-generated.

A new statistical method, the -TOST, improves average (bio)equivalence testing by correcting the two one-sided tests (TOST) procedure. This enhances power, especially for highly variable drugs, ensuring more reliable equivalence conclusions.

Keywords:
bioequivalenceinterval inclusion principlescaled average bioequivalencesimilarity testtwo one-sided test

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Area of Science:

  • Biostatistics
  • Pharmacometrics
  • Statistical Inference

Background:

  • Average (bio)equivalence tests determine if a parameter, such as mean difference, falls within predefined equivalence limits.
  • The standard Two One-Sided Tests (TOST) procedure is commonly used but can be conservative, leading to power loss with high variability.
  • This conservativeness can prevent concluding true equivalence, particularly in pharmaceutical applications with variable drug responses.

Purpose of the Study:

  • To introduce a finite sample correction for the TOST procedure, termed the -TOST.
  • To guarantee a controlled test size (Type I error rate) of for the corrected procedure.
  • To enhance the power of equivalence testing, especially in scenarios with high drug variability.

Main Methods:

  • Developed a finite sample and variability correction to the significance level of the TOST procedure.
  • The -TOST procedure adjusts the TOST to maintain a specified Type I error rate.
  • Evaluated the operating characteristics and power of the -TOST against existing methods.

Main Results:

  • The -TOST procedure is uniformly more powerful than the standard TOST.
  • The proposed method demonstrates superior operating characteristics compared to competing procedures.
  • A case study on econazole nitrate deposition in porcine skin illustrates the practical benefits and advantages of -TOST.

Conclusions:

  • The -TOST offers a statistically sound and more powerful alternative for average (bio)equivalence testing.
  • This corrected procedure effectively addresses the power loss issues of TOST in the presence of high variability.
  • The -TOST is computationally simple and provides improved reliability for concluding equivalence.