The ICH Management Committee on 10Nov2024 approved a proposal for M15: Model-Informed Drug Development General Principles Guideline.
It is expected to take 3 years to accomplish and the draft guideline is proposed to cover:
"The new overarching ICH M15 MIDD General Principles Guideline will broadly cover the
general principles and good practices for the use of MIDD. The guideline will establish a
common understanding across multidisciplinary scientists, both within and between regulatory
authorities and industry. Additionally, the guideline will harmonize expectations regarding
documentation standards, model development, data used in analysis, model assessment and its
applications."
The draft guideline is available here:
https://database.ich.org/sites/default/files/ICH_M15_ConceptPaper_Final_2022_1102.pdf
#ICH #MIDD
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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