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- Title
Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study.
- Authors
Rowland Yeo, Karen; Venkatakrishnan, Karthik
- Abstract
Physiologically-Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study Accelerated drug development for diseases with high unmet need demands patient focus without compromising scientific rigor. Such a strategy, while practically reasonable, may be at risk of limited translatability given the complexities of enzyme-transport interplay, enterohepatic recirculation, and extrahepatic metabolism often associated with molecules in the current drug development space. The foundation (Base) of the pyramid relates to quantitative assessment of clearance mechanisms, consisting of MB data and relevant I in vitro i studies that quantify enzyme/transporter contributions for the pathways informed by the MB study.
- Subjects
DRUG development; BIOAVAILABILITY
- Publication
Clinical Pharmacology & Therapeutics, 2021, Vol 109, Issue 1, p51
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1002/cpt.2092