Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report
Abstract The number of quantitative systems pharmacology (QSP) submissions to the U.S. Food and Drug Administration has continued to increase over the past decade. This report summarizes the landscape of QSP submissions as of December 2023. QSP was used to inform drug development across various ther...
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| Format: | Article |
| Language: | English |
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Wiley
2024-12-01
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| Series: | CPT: Pharmacometrics & Systems Pharmacology |
| Online Access: | https://doi.org/10.1002/psp4.13208 |
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| author | Jane P. F. Bai Guansheng Liu Miao Zhao Jie Wang Ye Xiong Tien Truong Justin C. Earp Yuching Yang Jiang Liu Hao Zhu Gilbert J. Burckart |
| author_facet | Jane P. F. Bai Guansheng Liu Miao Zhao Jie Wang Ye Xiong Tien Truong Justin C. Earp Yuching Yang Jiang Liu Hao Zhu Gilbert J. Burckart |
| author_sort | Jane P. F. Bai |
| collection | DOAJ |
| description | Abstract The number of quantitative systems pharmacology (QSP) submissions to the U.S. Food and Drug Administration has continued to increase over the past decade. This report summarizes the landscape of QSP submissions as of December 2023. QSP was used to inform drug development across various therapeutic areas and throughout the drug development process of small molecular drugs and biologics and has facilitated dose finding, dose ranging, and dose optimization studies. Though the majority of QSP submissions (>66%) focused on drug effectiveness, QSP was also utilized to simulate drug safety including liver toxicity, risk of cytokine release syndrome (CRS), bone density, and others. This report also includes individual contexts of use from a handful of new drug applications (NDAs) and biologics license applications where QSP modeling was used to demonstrate the utility of QSP modeling in regulatory drug development. According to the models submitted in QSP submissions, an anonymous case was utilized to illustrate how QSP informed development of a bispecific monoclonal antibody with respect to CRS risk. QSP submissions for informing pediatric drug development were summarized along with highlights of a case in inborn errors of metabolism. Furthermore, simulations of response variability with QSP were described. In summary, QSP continues to play a role in informing drug development. |
| format | Article |
| id | doaj-art-a7e647a5da584cbab6f6b190902bb27c |
| institution | Kabale University |
| issn | 2163-8306 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | CPT: Pharmacometrics & Systems Pharmacology |
| spelling | doaj-art-a7e647a5da584cbab6f6b190902bb27c2024-12-16T05:57:55ZengWileyCPT: Pharmacometrics & Systems Pharmacology2163-83062024-12-0113122102211010.1002/psp4.13208Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update reportJane P. F. Bai0Guansheng Liu1Miao Zhao2Jie Wang3Ye Xiong4Tien Truong5Justin C. Earp6Yuching Yang7Jiang Liu8Hao Zhu9Gilbert J. Burckart10Office of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Clinical Pharmacology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAAbstract The number of quantitative systems pharmacology (QSP) submissions to the U.S. Food and Drug Administration has continued to increase over the past decade. This report summarizes the landscape of QSP submissions as of December 2023. QSP was used to inform drug development across various therapeutic areas and throughout the drug development process of small molecular drugs and biologics and has facilitated dose finding, dose ranging, and dose optimization studies. Though the majority of QSP submissions (>66%) focused on drug effectiveness, QSP was also utilized to simulate drug safety including liver toxicity, risk of cytokine release syndrome (CRS), bone density, and others. This report also includes individual contexts of use from a handful of new drug applications (NDAs) and biologics license applications where QSP modeling was used to demonstrate the utility of QSP modeling in regulatory drug development. According to the models submitted in QSP submissions, an anonymous case was utilized to illustrate how QSP informed development of a bispecific monoclonal antibody with respect to CRS risk. QSP submissions for informing pediatric drug development were summarized along with highlights of a case in inborn errors of metabolism. Furthermore, simulations of response variability with QSP were described. In summary, QSP continues to play a role in informing drug development.https://doi.org/10.1002/psp4.13208 |
| spellingShingle | Jane P. F. Bai Guansheng Liu Miao Zhao Jie Wang Ye Xiong Tien Truong Justin C. Earp Yuching Yang Jiang Liu Hao Zhu Gilbert J. Burckart Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report CPT: Pharmacometrics & Systems Pharmacology |
| title | Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report |
| title_full | Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report |
| title_fullStr | Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report |
| title_full_unstemmed | Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report |
| title_short | Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report |
| title_sort | landscape of regulatory quantitative systems pharmacology submissions to the u s food and drug administration an update report |
| url | https://doi.org/10.1002/psp4.13208 |
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