Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs
| Autor: | Ping Zhao, Lawrence X. Yu, Paul Seo, Ho-Pi Lin, Yang Zhao, Heta Shah, Min Li, Fang Wu, S Suarez, Kimberly Raines, John Duan, Peng Duan, Meng Wang |
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| Rok vydání: | 2020 |
| Předmět: |
Physiologically based pharmacokinetic modelling
Computer science Metabolic Clearance Rate Chemistry Pharmaceutical Pharmaceutical Science 030226 pharmacology & pharmacy Models Biological law.invention Modeling and simulation 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Drug Development law Humans Computer Simulation Tissue Distribution Drug Approval New drug application Active ingredient Clinical pharmacology United States Food and Drug Administration Biopharmaceutics United States Drug Liberation Gastrointestinal Absorption 030220 oncology & carcinogenesis Biochemical engineering Critical quality attributes |
| Zdroj: | The AAPS journal. 23(2) |
| ISSN: | 1550-7416 |
| Popis: | Physiologically based pharmacokinetic (PBPK) absorption modeling and simulation is increasingly used as a tool in drug product development, not only in support of clinical pharmacology applications (e.g., drug-drug interaction, dose selection) but also from quality perspective, enhancing drug product understanding. This report provides a summary of the status and the application of PBPK absorption modeling and simulation in new drug application (NDA) submissions to the U.S. Food and Drug Administration to support drug product quality (e.g., clinically relevant dissolution specifications, active pharmaceutical ingredient (API) particle size distribution specifications). During the 10 years from 2008 to 2018, a total of 24 NDA submissions included the use of PBPK absorption modeling and simulations for biopharmaceutics-related assessment. In these submissions, PBPK absorption modeling and simulation served as an impactful tool in establishing the relationship of critical quality attributes (CQAs) including formulation variables, specifically in vitro dissolution, to the in vivo performance. This article also summarizes common practices in PBPK approaches and proposes future directions for the use of PBPK absorption modeling and simulation in drug product quality assessment.Graphical abstract. |
| Databáze: | OpenAIRE |
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