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  1. CDER Quantitative Medicine Center of Excellence (QM CoE)

Quantitative Medicine Center of Excellence (QM CoE) Educational Resources

Discover educational resources available under the QM CoE.

FDA/C-Path Institute Model Informed Drug Development Web-Based Training

  • The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE), in collaboration with CDER’s Office of Translational Sciences and the Critical Path Institute (C-Path), is pleased to provide free, web-based training modules on model-informed drug development (MIDD). Watch the playlist on YouTube. 

Workshops

Recent QM Publications

Faramarzi et al. Novel (Q)SAR models for prediction of reversible and time-dependent inhibition of cytochrome P450 enzymes. Front Pharmacol. 2025 Feb 12;15:1451164.

Heimbach et al. PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report. Mol Pharm. 2024 Nov 4;21(11):5353-5372.

Lautier et al. Clustering plasma concentration-time curves: applications of unsupervised learning in pharmacogenomics. J Biopharm Stat. 2025;35(4):678-696.

Liu et al. Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization. Clin Pharmacol Ther. 2024 Apr;115(4):890-895.

Mackie et al. Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. Mol Pharm. 2024 May 6;21(5):2065-2080.

Madabushi et al. The US Food and Drug Administration’s Model-Informed Drug Development Meeting Program: From Pilot to Pathway. Clin Pharmacol Ther. 2024 Aug; 116(2):278 – 281.

Mou et al. Quantitative Structure-Activity Relationship Models to Predict Cardiac Adverse Effects. Chem Res Toxicol. 2024 Nov 13.

Pepin et al. Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report. Mol Pharm. 2024 Aug 5;21(8):3697-3731.

Pisal et al. Model Informed Drug Development (MIDD) Based Approval of Intravenous Secukinumab for the Treatment of Adult Patients with PsA, AS, and nr-axSpA. Clin Pharmacol Ther. 2025 Feb;117(2):475-484.

Sharma et al. Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions. J Clin Pharmacol. 2024 Dec;64(12):1484-1490.

Starling et al. The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making. Clin Pharmacol Ther. 2025 Feb;117(2):343-352.

Tannergren et al. Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report. Mol Pharm. 2025 Jan 6;22(1):5-27.

Tsakalozou et al. Considering Opportunities and Challenges When Implementing the Model Master File Framework – a Meeting Report. Pharm Res. 2025 Mar 7.

Wang et al. Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins. Clin Pharmacol Ther. 2024 Mar;115(3):440-451.

Weng et al. First, Do No Harm: Addressing AI’s Challenges With Out-of-Distribution Data in Medicine. Clin Transl Sci. 2025 Jan;18(1):e70132.

Yuan et al. The Application of Model-Informed Drug Development in Dose Selection and Optimization for siRNA Therapies. J Clin Pharmacl. 2024 Jul;64(7):799-809.

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