Bioequivalence and Bioavailability Forum

Hello, dear colleagues!

Some time ago two packages for bioequivalence and pharmacokinetics was relesed. (Julia is a high-level, high-performance, dynamic programming language. Who knows nothing about Julia can look here.)

One released package is ReplicateBE.jl. This package made for parameter estimation in linear mixed-effects models with restricted maximum likelihood method and provides variance components and fixed-effect coefficients with confidence intervals estimates. Covariance structure: CSH (Type C). Confidence interval (90%) for bioequivalence included in standard output.

Results was compared with IBM SPSS v25 (MIXED), validation program include following design types:

• 24 subjects, sequence balanced dataset
  • TRTR/RTRT
    
  • TRRT/RTTR
    
  • TTRR/RRTT
    
  • TRT/RTR
• 48 subjects, sequence unbalanced, 20 randomly dropped observations
  • TRTR/RTRT
    
  • TRRT/RTTR
    
  • TTRR/RRTT
    
  • TRT/RTR
• 36 subjects, sequence unbalanced dataset
  • TRTR/RTRT
    
  • TRT/RTR
• 128 subjects, sequence unbalanced dataset
  • TRTR/RTRT
    
  • TRT/RTR
• 512 subjects, sequence unbalanced dataset
  
  • TRTR/RTRT
    
  • TRT/RTR
• 1024 subjects, sequence unbalanced, 2000 randomly dropped observations
  
  • TRTR/RTRT
• 4096 subjects, sequence unbalanced, 2000 randomly dropped observations

This and other results can found here. Current package version is 1.0.4 - this is a public release with stable API and some validation checks. Package stable in basic using patterns, but approximately 1 from 10^5 datasets lead to handled critical error (no wrong results because no results at all).

Package version 1.1.0 would be first public stable release.

Second package is ClinicalTrialUtilities.jl. This package provides related clinical trial calculations: descriptive statistics, power and sample size calculation, power simulations (bioequivalence), confidence interval, pharmacokinetics / pharmacodynamics parameters calculation. TOST approach based on PowerTOST R package. Scope of package - development unified system for sample size estimating and simulation, PK data analysis with following descriptive statistics and export with interface to ReplicateBE if necessary.

Current package version is 0.2.0 - this is a public beta release with basic functionality. Documents and description can be found here.

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Edit: Tabulators changed to spaces and BBcoded to lists; see also this post #6. [Helmut]