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. 2020 Dec;9(12):675-677.
doi: 10.1002/psp4.12567. Epub 2020 Nov 7.

A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development

Jane P F Bai  1 , Justin C Earp  1 , David G Strauss  1 , Hao Zhu  1
Affiliations

A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development

Jane P F Bai et al. CPT Pharmacometrics Syst Pharmacol. 2020 Dec.
No abstract available

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Conflict of interest statement

The authors declared no competing interests for this work.

Figures

Figure 1
Figure 1
Quantitative systems pharmacology (QSP) models to guide late‐stage drug development should be iteratively calibrated and validated to (1) maximize model credibility with adequate amounts of pharmacodynamic (PD) biomarker data of high quality and (2) minimize decision risk with context‐specific predetermined quantitative/statistical criteria.
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References

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    1. Bai, J.P.F. , Earp, J.C. & Pillai, V.C. Translational quantitative systems pharmacology in drug development: from current landscape to good practices. AAPS J. 21, 72 (2019). - PubMed
    1. The United States Food and Drug Administration . Drugs@FDA. <https://wwwac​cessd​atafd​agov/scrip​ts/cder/daf/indexcfm>. Accessed July 2020.
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