Overview of Bioequivalence in Pumas

Pumas supports bioequivalence analysis via two packages. Bioequivalence (BE) and BioequivalencePower (BEP). You may load these packages via,

using Bioequivalence

and

using BioequivalencePower

The Bioequivalence package supports data analysis of datasets from bioequivalence studies for concluding results of a bioequivalence study. This is the package to use if you are conducting analysis of data resulting from a bioequivalence study.

The BioequivalencePower package works on assumptions of previous studies or pilot studies to provide power estimates, aid with sample size determination for studies, and conduct related analysis. This is the package to use when you are planning a bioequivalence study.

Contents of Bioequivalence

• Bioequivalence Data Analysis
• • Quickstart
  • What is bioequivalence?
  • Designs
  • • Nonparametric analysis (i.e., x formulations, y sequences, z periods)
    • Parallel design (i.e., x formulations, y periods, z sequences, e.g. R|S|T)
    • Crossover designs
    • Analysis of crossover designs
    • Supported designs
• Easy API Reference for BioequivalencePower
• • Power
  • Sample size
  • Power Analysis
  • Adjusted α
  • Confidence Interval
  • p-value
• Study Type Details in BioequivalencePower
• • Standard (average) Bioequivalence
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Types
      • Power
      • Power Analysis
      • Confidence interval
      • p-value
  • Reference scaling and/or expanding limits
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Types
      • Power
      • Power Analysis
      • Adjusted α
  • Narrow therapeutic drug index products
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Types
      • Power
      • Power Analysis
  • Fiducial inference
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Types
      • Power
      • Confidence interval
  • Two simultaneous end points
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Types
      • Power
  • Dose proportionality
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Types
      • Power
    • Further notes
  • Non-inferiority
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Types
      • Power
  • Priors on parameters in power studies
  • • Statistical background
    • Basic examples
    • Key docstrings
    • • Prior types
      • Parameter types (parameters and distribution are implied)
      • Power (expected) for RatioTOST
      • • Prior on CV
        • Prior on θ₀
        • Prior on both CV and θ₀
      • Power (expected) for DifferenceTOST
      • • Prior on CV
        • Prior on θ₀
        • Prior on both CV and θ₀
      • Power (expected) for NonInferiorityRatioOST
      • • Prior on CV
        • Prior on θ₀
        • Prior on both CV and θ₀
      • Power (expected) for NonInferiorityDifferenceOST
      • • Prior on CV
        • Prior on θ₀
        • Prior on both CV and θ₀
• Reference and Utility Functions for BioequivalencePower
• • General
  • Sample size
  • Computation types
  • Utilities for experimental designs
  • Utilities for variability parameters
  • Utilities for Reference scaling and/or expanding limits
  • Full list of method doc strings for key functions