Author: [AUTHOR] Published on 8/13/2025 12:00:00 AM
CALL FOR PAPERS: Quantitative Medicine
Clinical and Translational Science invites submissions for a special collection dedicated to Quantitative Medicine for Drug Discovery, Development, and Clinical Utilization.
Background
Bringing new therapeutic agents to patients entails significant expenses, time, and risks, compounded by scientific, regulatory, and clinical utilization challenges. In response to these challenges, innovative quantitative approaches and technologies, collectively known as Quantitative Medicine (QM), are being incorporated into drug discovery and development to improve efficiencies and patient outcomes.
Quantitative Medicine involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches using nonclinical, clinical, and real-world data to optimize end-to-end drug development efficiency. By enabling informed decision-making and treatment optimization, QM aims to bring transformative medicines to clinical utilization in a timely manner.
With the FDA's establishment of a CDER Quantitative Medicine Center of Excellence in March 2024 to catalyze the integration and consistent application of QM methodologies across drug development lifecycles, there is growing momentum for advancing this field.
Scope
We welcome submission of original research articles, brief reports, mini-reviews, reviews, tutorials, perspectives, and position papers that explore or contribute to the field of quantitative medicine in drug development, translational science, and clinical pharmacology.
Topics of Interest
Topics include, but are not limited to:
- Quantitative Modeling and Simulation Tools: • Population pharmacokinetics (PK) and pharmacodynamics (PD) • Exposure-response modeling • Mechanistic PK/PD modeling • Quantitative systems pharmacology (QSP) modeling • Artificial intelligence and machine learning (AI/ML) applications
- End-to-End Drug Development Applications: • Target selection and validation • Lead optimization and modality development • Forward and reverse translation • Dose optimization and combination strategies • Formulation bridging and alternative dosing schedules • Generic drug development • First-in-human dose prediction
- Clinical Applications and Precision Medicine: • Individualized patient treatment optimization • Model-informed drug development (MIDD) • Digital health technologies in clinical trials • Real-world evidence integration • Patient-centric treatment approaches
- Regulatory Science and Global Perspectives: • Risk-based regulatory assessment of quantitative approaches • Model Master File frameworks • Global regulatory acceptance and harmonization • Return on investment analyses for QM implementation
- Post-Approval Applications and Lifecycle Management: • Real-world evidence for post-approval dosing optimization • Collaborative approaches for drug access in low- and middle-income countries • Medical affairs applications of quantitative medicine
- Challenges and Solutions: • Barriers to wide adoption of QM in drug development • Strategies to promote global regulatory acceptance • Enhancing R&D productivity through quantitative approaches
Submission Information
Please contact ctseditor@ascpt.org for details about manuscript types and format requirements, or review our Author Guidelines here.
Any relevant manuscripts submitted before January 31, 2026 would be considered for the collection. Authors who have a relevant submission but cannot meet the January 31, 2026 deadline can inquire with the editorial office (ctseditor@ascpt.org) for a potential extension.
If you would like to make a pre-submission inquiry, please contact the CTS editorial office at ctseditor@ascpt.org.
