In the realm of healthcare, model-informed approaches are setting transformative trends, merging the trails of drug development with the rapidly evolving sector of personalized medicine. This fusion is facilitated through comprehensive computational modeling, facilitating nuanced drug therapies tailored to individual patient profiles and conditions. Groundbreaking advancements in pharmacokinetic and pharmacodynamic modeling, along with the integration of vast genetic, epigenetic, and real-world data, are paving the way for this targeted approach.

This Research Topic aims to compile a body of work that underscores the pivotal role of model-informed strategies in revolutionizing personalized medicine and drug development processes. Key objectives include mapping the advancements in various modeling methodologies such as PK, PD, and systems pharmacology, and exploring their implications for patient-specific therapy optimization. Furthermore, this topic seeks to investigate the integration of diverse biological data into these models, thus elevating the precision and efficacy of personalized treatment paradigms.

To gather further insights on the boundaries between cutting-edge modeling and clinical application, we welcome articles addressing, but not limited to, the following themes:

The role of popPK/PD, PBPK, MBMA, QSP, and TTE models in personalizing drug therapies.

Advances in integrating pharmacokinetic and pharmacodynamic modeling in drug development.

The impact of genetic, epigenetic, and real-world data on the accuracy of model-informed approaches.

Strategies for fostering interdisciplinary collaboration to enhance the translational impact of preclinical findings.

Challenges and future perspectives in applying model-informed approaches to regulatory science and healthcare equity.

Contributions may include original research, comprehensive reviews, and opinion pieces that explore these dimensions, aiming to bridge the gap between theoretical modeling and practical, clinically relevant outcomes.

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Model-Informed Approaches: Uniting Drug Development with Personalized Medicine