Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of...

Area of Science:

• Pharmacology and Clinical Pharmacy
• Pharmacometrics and Pharmacokinetics
• Health Services Research

Background:

• Traditional drug therapy often uses a one-size-fits-all approach, leading to suboptimal patient outcomes.
• Individual patient variability in drug response necessitates personalized dosing strategies.
• Model-informed precision dosing (MIPD) represents a paradigm shift towards individualized pharmacotherapy.

Purpose of the Study:

• To provide a comprehensive overview of current knowledge, practices, and opinions on MIPD.
• To define an evidence-based vision for the achievable implementation of MIPD in clinical practice.
• To explore novel methods for characterizing patient variability in drug response.

Main Methods:

• Historical review of dose variability and the evolution of precision dosing.
• Discussion of technical aspects including clinical decision support tools, validation, and implementation strategies.
• Exploration of patient variability beyond genetic factors and analysis of current debates in drug development, health economics, and regulation.

Main Results:

• MIPD integrates patient-specific data to optimize drug therapy.
• The review highlights the need for robust decision support systems and practical validation for MIPD.
• Novel approaches to understanding patient variability are crucial for advancing MIPD.

Conclusions:

• MIPD offers a promising framework for enhancing drug therapy individualization.
• Successful clinical integration requires addressing technical, regulatory, and economic challenges.
• A collaborative approach is essential to realize the full potential of MIPD in healthcare.