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. 2015 Mar;4(3):e00020.
doi: 10.1002/psp4.20. Epub 2015 Mar 12.

FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?

M C Peterson  1 , M M Riggs  2
Affiliations

FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?

M C Peterson et al. CPT Pharmacometrics Syst Pharmacol. 2015 Mar.

Abstract

In the evolving discipline of quantitative systems pharmacology (QSP), QSP model (QSPM) applications are expanding. Recently, a QSPM was used by US Food and Drug Administration (FDA) clinical pharmacologists to evaluate the appropriateness of a proposed dosing regimen for a new biologic. This application expands the use-horizon for QSPMs into the regulatory domain. Here we retrace the evolution of the model and suggest a question-based approach to directing model scope, identifying applications, and understanding overall QSPM value.

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Figures

Figure 1
Figure 1
Schematic of calcium homeostasis and bone QSPM (reprinted with permission from Peterson and Riggs, 20102).
See this image and copyright information in PMC

References

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