[ANN] MetidaBioeq.jl - Bioequivalence estimation

[PharmCat]

Soon MetidaBioeq.jl will be in registry. This is a first release and it support only basic bioequivalence estimation in accordance with:

• EMA: GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE

• EMA: GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE, Annex I

• FDA: Guidance for Industry Statistical Approaches to Establishing Bioequivalence

Package include method bioequivalence that create BE structure with dataset and check it, and method result that make estimation (with GLM, MixedModels or Metida).

Version 0.1.0 not support adaptive design and reference scaling (it can be done manually). Also not included post-hoc power calculation, CV estimation and type III table (ANOVA/F-test) estimation - this is goals for further updates.

Validation with reference datasets and integration with MetidaNCA also in plans.

After all basic features will be included automatic report module can be started.

See documentation. Don’t hesitate to make issues on github.

Requirements

• Julia ≥1.8+
• MixedModels ≥4.11
• GLM ≥1.8.2
• Metida ≥0.14.6

To install just now from main brunch

import Pkg
Pkg.add(url = "https://github.com/PharmCat/MetidaBioeq.jl.git")

[PharmCat]

Version 0.2.3 released.

Docs can be found here.

Supported:

• Parallel design
• Cross-over design
• High-order (replicate) designs

Validated with:

• Fuglsang, A., Schütz, H., & Labes, D. (2015). Reference datasets for bioequivalence trials in a two-group parallel design. The AAPS journal, 17(2), 400–404. Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design | The AAPS Journal

• Schütz, H., Labes, D., & Fuglsang, A. (2014). Reference datasets for 2-treatment, 2-sequence, 2-period bioequivalence studies. The AAPS journal, 16(6), 1292–1297. Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies | The AAPS Journal

• Schütz, H., Labes, D., Tomashevskiy, M., la Parra, M. G., Shitova, A., & Fuglsang, A. (2020). Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits. The AAPS journal, 22(2), 44. Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits | The AAPS Journal

• SPSS output for FDA model from [FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence](https://www.fda.gov/media/70958/download, APPENDIX F.

In plan:

• Welch correction for parallel design
• Reference scaled bioequivalence
• Non-parametric test
• CV-intra