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. 2019 Jun;8(6):336-339.
doi: 10.1002/psp4.12403. Epub 2019 Apr 11.

Quantitative Systems Pharmacology: A Regulatory Perspective on Translation

Issam Zineh  1
Affiliations

Quantitative Systems Pharmacology: A Regulatory Perspective on Translation

Issam Zineh. CPT Pharmacometrics Syst Pharmacol. 2019 Jun.
No abstract available

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Conflict of interest statement

The author declared no competing interests for this work.

Figures

Figure 1
Figure 1
Conceptualizing emerging regulatory science on the hope‐hype continuum. Quantitative systems pharmacology (QSP) is one of several regulatory sciences that have followed a hope‐hype lifecycle. Other regulatory sciences, such as exposure/response (E/R) modeling and simulation, precision medicine/pharmacogenomics (Pgx), and physiologically‐based pharmacokinetic (PBPK) modeling and simulation are at various stages on this continuum. The significant investment by the scientific community in defining the opportunities, challenges, uses, and best practices in QSP should, at minimum, lower the peak of inflated expectations and may facilitate more integration of QSP in drug discovery, development, and regulatory evaluation. Note: The point estimates are for conceptual purposes only; it could be argued that placement of these points on the hope‐hype curve are context‐dependent and highly subjective. All representations are for the science in a regulatory context (e.g., as opposed to in clinical practice).
Figure 2
Figure 2
Quantitative systems pharmacology (QSP) submissions to the US Food and Drug Administration (FDA) over time. Number of regulatory submissions to the FDA containing QSP information over time. Regulatory submissions include investigational new drug (IND) applications, new drug applications (NDAs), and biologics license applications (BLAs). Submissions were identified through direct query of review staff in the FDA Office of Clinical Pharmacology; the graph should be considered an estimate. The hashed line represents the moving average number of submissions.
See this image and copyright information in PMC

References

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