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Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study

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Accelerated drug development for diseases with high unmet need demands patient focus without compromising scientific rigor. Precision dosing informed by physiologically-based pharmacokinetic (PBPK) models will enable inclusive clinical trials and… Click to show full abstract

Accelerated drug development for diseases with high unmet need demands patient focus without compromising scientific rigor. Precision dosing informed by physiologically-based pharmacokinetic (PBPK) models will enable inclusive clinical trials and narrow the gap between clinical development and realworld use. Early incorporation of the mass balance (MB) study is crucial to maximize the fidelity of a PBPK model-informed approach to precision dosing across populations and contexts of use in clinical development and therapeutic use.

Keywords: drug development; mass balance; based pharmacokinetic; precision dosing; physiologically based; development

Journal Title: Clinical Pharmacology and Therapeutics
Year Published: 2020

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