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Model-Informed Drug Development for Anti-Infectives: State of the Art and Future
Craig R Rayner1,2, Patrick F Smith1, David Andes3
1Certara, Princeton, New Jersey, USA.
Clinical Pharmacology and Therapeutics
|February 8, 2021
Summary
Model-informed drug development (MIDD) advances anti-infective research by integrating pharmacology, pathogen biology, and host factors. Future MIDD will deepen insights and broaden adoption for better drug development decisions.
Area of Science:
- Pharmacology and Infectious Diseases
- Translational Science
- Drug Development
Background:
- Model-informed drug development (MIDD) has a significant history in infectious diseases.
- Translational anti-infective pharmacology requires careful selection of exposure and pharmacodynamic (PD) measures, consideration of patient subpopulations, and drug-drug interactions.
Purpose of the Study:
- To review foundational principles of translational anti-infective pharmacology and MIDD applications.
- To summarize the adoption of MIDD practices in infectious diseases.
- To outline future directions for MIDD in infectious diseases, focusing on 'depth' and 'breadth'.
Main Methods:
- Review of existing literature and case examples of MIDD applications.
- Analysis of MIDD principles including exposure and PD measures, subpopulations, and drug-drug interactions.
- Exploration of MIDD in antibacterials, antifungals, antivirals, global health drugs, and medical countermeasures.
Main Results:
- MIDD principles are crucial for anti-infective drug development.
- Diverse MIDD applications exist across various anti-infective classes and development stages.
- Current adoption of MIDD varies across the infectious diseases field.
Conclusions:
- Future MIDD will enhance 'depth' by incorporating pathogen biology, host factors, and resistance mechanisms.
- Future MIDD will expand 'breadth' through greater adoption and systematic integration of model-centered approaches.
- Improved early assessment of resistance emergence is a key future focus for MIDD in infectious diseases.
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