Model-Informed Drug Development and Evidence-Based Translational Pharmacology, Volume II

Model-informed drug development (MIDD) integrates pharmacometrics, systems pharmacology, and decision analytics to transform preclinical and clinical data into actionable insights that accelerate development and improve patient outcomes. Regulatory agencies including the FDA, EMA, PMDA, and CFDA formally recognize MIDD as a key enabler of efficient and effective drug development, highlighting its role in dose selection, trial optimization, and benefit–risk assessment.In 2022, the original Research Topic “Model-Informed Drug Development and Evidence-Based Translational Pharmacology” was published. Since then, the field has advanced along several vectors from the convergence of pharmacometrics with quantitative systems pharmacology to the expansion of model-informed precision dosing into routine clinical decision support. Volume II aims to serve as a forward-looking forum for cutting-edge MIDD methods and applications that concretely advance translational pharmacology. A key addition to this new volume will be an exploration of the extent to which Large Language Models (LLMs) and AI agents can support MIDD. We particularly welcome work that integrates empirical and mechanistic models with robust data from preclinical and clinical sources, demonstrates decision impact, and aligns with regulatory science and clinical translation. Areas to be covered in this Research Topic may include, but are not limited to:• Pharmacometric innovations and decision impact• Model-informed precision dosing (MIPD)• PBPK and translational extrapolation• Quantitative systems pharmacology and systems biology• Hybrid mechanistic–data-driven methods• Pharmacoeconomics and decision analytics• Chemoinformatics for translatability• Clinical reports and real-world applications• Applications of AI, including LLMs and agents, to support MIDD Topic editors: Amal Kaddoumi, S. Y. Amy Cheung, Yu-Wei Lin Source: https://www.frontiersin.org/research-topics/77525/model-informed-drug-development-and-evidence-based-translational-pharmacology-volume-ii