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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| Main Authors: | 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 |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-12-01
|
| Series: | CPT: Pharmacometrics & Systems Pharmacology |
| Online Access: | https://doi.org/10.1002/psp4.13208 |
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