Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology
Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory applications submitted to the US Food and Drug Administration (FDA). In 2018, the Food and Drug Administration's Office of Clinical Pharmac...
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| Published in | Journal of clinical pharmacology Vol. 60 Suppl 1; p. S160 |
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| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
01.10.2020
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| Abstract | Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory applications submitted to the US Food and Drug Administration (FDA). In 2018, the Food and Drug Administration's Office of Clinical Pharmacology published a commentary summarizing the application of PBPK modeling in the submissions it received between 2008 and 2017 and its impact on prescribing information. In this commentary, we provide an update on the application of PBPK modeling in submissions received between 2018 and 2019 and highlight a few notable examples. |
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| AbstractList | Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory applications submitted to the US Food and Drug Administration (FDA). In 2018, the Food and Drug Administration's Office of Clinical Pharmacology published a commentary summarizing the application of PBPK modeling in the submissions it received between 2008 and 2017 and its impact on prescribing information. In this commentary, we provide an update on the application of PBPK modeling in submissions received between 2018 and 2019 and highlight a few notable examples. |
| Author | Yang, Yuching Wang, Yaning Grimstein, Manuela Zhang, Xinyuan Huang, Shiew-Mei Fan, Jianghong Grillo, Joseph A Zhu, Hao |
| Author_xml | – sequence: 1 givenname: Xinyuan surname: Zhang fullname: Zhang, Xinyuan organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 2 givenname: Yuching surname: Yang fullname: Yang, Yuching organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 3 givenname: Manuela surname: Grimstein fullname: Grimstein, Manuela organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 4 givenname: Jianghong surname: Fan fullname: Fan, Jianghong organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 5 givenname: Joseph A surname: Grillo fullname: Grillo, Joseph A organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 6 givenname: Shiew-Mei surname: Huang fullname: Huang, Shiew-Mei organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 7 givenname: Hao surname: Zhu fullname: Zhu, Hao organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA – sequence: 8 givenname: Yaning surname: Wang fullname: Wang, Yaning organization: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33205429$$D View this record in MEDLINE/PubMed |
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| Keywords | modeling and simulation PBPK drug-drug interactions pharmacokinetics and drug metabolism clinical pharmacology (CPH) MIDD (model-informed drug development) |
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| Title | Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology |
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