Updates of bioequivalence programs (including statistical power approximated by Student's t)

Area of Science:

• Pharmacometrics
• Biostatistics
• Clinical Trial Analysis

Background:

• Previous MS-DOS programs (BIOEQV37, BIOPAR37, BIOEQNEW) provided statistical analysis for bioequivalence studies.
• Need for updated software to incorporate advanced statistical methods and improve accuracy in power calculations.

Purpose of the Study:

• To introduce updated versions of MS-DOS bioequivalence analysis software: BIOEQV52, BIOPAR40, and BIOEQNEW.
• To detail modifications and improvements in these new software versions.
• To enhance the statistical power calculations for two-period crossover bioequivalence studies.

Main Methods:

• Updated software programs incorporating Schuirmann's two one-sided tests procedure for statistical power calculations.
• Utilized Student's t-statistic to approximate power, demonstrating its effectiveness.
• Applied methods to both 'additive' and 'multiplicative' models for bioequivalence analysis.

Main Results:

• New software versions (BIOEQV52, BIOPAR40, BIOEQNEW) are available with enhanced features.
• Student's t-statistic provides accurate approximations for statistical power in two-period crossover studies.
• Power calculation methods are validated for both additive and multiplicative models.

Conclusions:

• The updated software offers improved statistical power analysis for bioequivalence studies.
• Student's t-statistic is a reliable method for approximating power, applicable to various models.
• These advancements facilitate more robust and accurate bioequivalence assessments.