Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Quantitative systems pharmacology (QSP) has been proposed as a scientific domain that can enable efficient and informative drug development. During the past several years, there has been a notable increase in the number of regulatory submissions that contain QSP, including Investigational New Drug A...

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Bibliographic Details
Published in:CPT: pharmacometrics and systems pharmacology 2021-12, Vol.10 (12), p.1479-1484
Main Authors: Bai, Jane P. F., Earp, Justin C., Florian, Jeffry, Madabushi, Rajanikanth, Strauss, David G., Wang, Yaning, Zhu, Hao
Format: Article
Language:English
Subjects:
Biological products
Biology
Biomarkers
Corporate sponsorship
Drug development
Drug dosages
Pharmaceutical industry
Pharmacology
R&D
Research & development
Simulation
Toxicology
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Summary:Quantitative systems pharmacology (QSP) has been proposed as a scientific domain that can enable efficient and informative drug development. During the past several years, there has been a notable increase in the number of regulatory submissions that contain QSP, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs) to the US Food and Drug Administration. However, there has been no comprehensive characterization of the nature of these regulatory submissions regarding model details and intended applications. To address this gap, a landscape analysis of all the QSP submissions as of December 2020 was conducted. This report summarizes the (1) yearly trend of submissions, (2) proportion of submissions between INDs and NDAs/BLAs, (3) percentage distribution along the stages of drug development, (4) percentage distribution across various therapeutic areas, and (5) nature of QSP applications. In brief, QSP is increasingly applied to model and simulate both drug effectiveness and safety throughout the drug development process across disease areas.
ISSN:2163-8306
2163-8306
DOI:10.1002/psp4.12709