Prediction of Enfuvertide Concentration-Time Profile in a Paediatric Population after Parenteral Administration Using a Physiologically Based Pharmacokinetic Model
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Tag: Pediatric
The Modernization of Orphan Drug Development
Orphan drugs affect 350,000 people worldwide, including 10% of the US population and 1 in 25 Europeans. Model-informed drug development (MIDD) approaches, such as PBPK and PopPK have been embraced by sponsors and regulators, and play a key role in modernizing and accelerating orphan drug development.
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Considering Age Variation When Coining Drugs as High Versus Low Hepatic Extraction Ratio
The hepatic extraction ratio (EH) is commonly considered an “inherent attribute” of drug. It determines the main physiological and biological elements of the system (patient attributes) that are most significant in interindividual variability of clearance. The EH consists of three age-dependent parameters: fraction of unbound drug in blood (fu.B), hepatic intrinsic clearance of unbound drug […]
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