Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report

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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https://doi.org/10.1002/psp4.13208

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