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Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs

Fang Wu, Heta Shah, Min Li, Peng Duan, Ping Zhao, Sandra Orozco‐Suárez, Kimberly Raines, Yang Zhao, Meng Wang, Ho-Pi Lin, John Duan, Lawrence X. Yu, Paul Seo

2021The AAPS Journal62 citationsDOI

Topics & Concepts

Physiologically based pharmacokinetic modellingBiopharmaceuticsPharmacokineticsPharmacologyDrugDissolution testingFood and drug administrationBiopharmaceutics Classification SystemBiochemical engineeringChemistryComputer scienceMedicineEngineeringIn vitroPharmacognosyBiochemistryBiological activityDrug Solubulity and Delivery SystemsProtein purification and stabilityAnalytical Chemistry and Chromatography
Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs | Litcius