On 29Jan26, the Regulatory Members of ICH adopted M15 GENERAL PRINCIPLES FOR MODEL-INFORMED DRUG DEVELOPMENT. The Introduction does a nice job of framing the intent and background for the guideline which will be of interest to many in AAPS.
"1. INTRODUCTION
1.1. Objective of the Guideline
This Guideline provides general recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development (MIDD), hereafter "MIDD evidence." It establishes a harmonized assessment framework (including associated terminology) for MIDD evidence.
1.2. Background
For the purposes of this Guideline, MIDD is defined as the use of computational modeling and simulation (M&S) methods that can include and integrate nonclinical data, clinical data, prior information, and knowledge (e.g., drug and disease characteristics) to generate evidence. The generated MIDD evidence is used to inform drug development and decision-making by drug developers, regulatory authorities, and other stakeholders."
The guideline can be found here: https://database.ich.org/sites/default/files/ICH_M15_Step4_Final_Guideline_2026_0129.pdf
#ICH #M15 #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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