@PI we plan to provide the T2EQ method in JMP version 18, based on the papers by Hoffelder. We will look into the other methods listed.
Link to EMA guidance:
- In Vitro Dissolution Profile Comparison for Bioequivalence Inference
published August 2023, European Medicines Agency, Q&A 3.13
https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/clinical-pharmacology-pharmacokinetics-questions-answers#3.-bioequivalence-(general)-section
Reference to Hoffelder metrics
- Hoffelder T, Gössl R, Wellek S
Multivariate equivalence tests for use in pharmaceutical development
J. of Biopharm. Stat. (2015), 25, p. 417-437 - Hoffelder T, Leblond D, Van Alstine L, Diaz DA, Suarez-Sharp S, Witkowski K, et al.
Dissolution profile similarity analyses – statistical principles, methods and considerations.
AAPS J. 2022;24(3):54 - Abend A, Zhang L, Fredro-Kumbaradzi E, Hoffelder T, Cohen M, Anand O, et al.
Current approaches for dissolution similarity assessment, requirements, and global expectations.
AAPS J. 2022;24(3):50 - Abend A, Hoffelder T, Cohen M, Van Alstine L, Argelia Diaz D, et al.
Dissolution profile similarity assessment – best practices, decision trees and global harmonization.
AAPS J. 2023;25(1):44.
References to correct implementation of bootstrapping of E(f2)
- Xu Z
Simulation and Comparison of Dissolution Profiles
Bootf2 package, version 0.4.1, 19/08/2021
https://github.com/zhengguoxu/bootf2 - Xu Z, Merino-Sanjuan M, Mangas-Sanjuan V, Garcia-Arieta A
Estimators and confidence intervals of f2 using bootstrap methodology for the comparison of dissolution profiles
Computer Methods and Programs in Biomedicine 2021, (212) 106449
Thanks for the comprehensive list of references! Very helpful.
What inspired this wish list request?
Comparative dissolution testing is supported by JMP 17.2.0 standard edition, but the offered functionality is not in compliance with the latest EMA guidance.
Recent proposed metrics by Hoffelder (AAPS 2023 paper) are not available.
What is the improvement you would like to see?
Next to bootstrapping of the expected value of f2, in compliance with EMA rules (August 2023), metrics proposed by Hoffelder should preferably be added (T2EQ, SE and EDNA).
Why is this idea important?
Currently, the mentioned functionality is created in R and Matlab code, only accessible to a few people. Having this functionality in JMP will avoid the need for programming skills and additional programming platforms. This will bring the analysis options in reach of the experimenters who measured the data.
So, it is about ease of use and for pharma professionals a must have.
What about the addition of the estimation of the expected f2, as required by EMA?
"In case of bootstrapping, similarity in dissolution profiles will be concluded when the lower limit of the 90% confidence interval for the Expected f2 is ≥ 5" (https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/clinical-pharmacology-pharmacokinetics-questions-answers#3-bioequivalence-general-6937)
T2EQ is available in JMP 18.
