FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?
Open accessAbstract
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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The ease of reproducibility is critical if QSP is to play a greater role in drug development and regulatory decisions.
“The ease of reproducibility is also critical if QSP is to play a greater role in drug development and regulatory decisions.8”
From Reproducibility of Quantitative Systems Pharmacology Models: Current Challenges and Future Opportunities (2019) · cites this paper as [8]
In “QSP Enters the Regulatory Arena” (page unavailable), the paper says regulatory acceptance requires scrutiny of model parameters and validation, and describes an independent evaluation that increased confidence. It does not say that ease of reproducibility is critical to QSP’s wider use in drug development or regulatory decisions. (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn the 2013 filing of recombinant human parathyroid hormone (rhPTH) for the treatment of hypoparathyroidism, FDA reviewers used a publicly available calcium homeostasis QSP model to explore alternative dosage regimens.
“The US Food and Drug Administration (FDA) reviewers raised some concerns about the hypercalciuria being observed in the clinical study and used a publicly available calcium homeostasis QSP model12 to explore alternative dosage regimens.”
From Best Practices to Maximize the Use and Reuse of Quantitative and Systems Pharmacology Models: Recommendations From the United Kingdom Quantitative and Systems Pharmacology Network (2019) · cites this paper as [11]
The “QSP Enters the Regulatory Arena” section says FDA reviewers used an open-source QSP model to evaluate alternative dosing regimens for rhPTH treatment of hypoparathyroidism and recommended optimization because of hypercalciuria concerns. It dates the advisory meeting to September 2014 but does not establish that the application was filed in 2013. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn a regulatory setting, knowledge derived from a QSP model can translate into approval or rejection of a license application.
“In a regulatory setting, the knowledge derived from a QSP model can translate into an approval (e.g., the rhPTH example11) or a rejection of the license application.”
From Best Practices to Maximize the Use and Reuse of Quantitative and Systems Pharmacology Models: Recommendations From the United Kingdom Quantitative and Systems Pharmacology Network (2019) · cites this paper as [11]
In “QSP Enters the Regulatory Arena” (page unavailable), the paper says FDA reviewers used a QSP model to assess the rhPTH license application and recommended further dose optimization. It does not say that the model led to approval or rejection of that application, or document either outcome for another application. (LLM, conf=0.86)
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References 7 · Cited by 77
- Authors
- Peterson, M., & Riggs, M.
- Affiliations
- Global Clinical Pharmacology, Pfizer Inc.Cambridge Massachusetts USA
- Metrum Research GroupTariffville Connecticut USA
- Venue
- CPT: Pharmacometrics & Systems Pharmacology
- Publisher
- Wiley
- Published
- 2015-03
- Volume
- 4
- Issue
- 3
- Pages
- 189-192
- ISSN
- 2163-8306 (ISSN-L)
- PMC
- PMC4394612
- OpenAlex
- W1554237150
- Cited by
- 77
- References
- 7
- Citations by year
- 2026: 1 · 2025: 6 · 2024: 4 · 2023: 2 · 2022: 5 · 2021: 9 · 2020: 3 · 2019: 10 · 2018: 13 · 2017: 10 · 2016: 11 · 2015: 3
- FWCI
- 10.98
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- CPT Pharmacometrics & Systems Pharmacology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Physical Sciences › Computer Science › Computational Theory and Mathematics › Computational Drug Discovery Methods
- Keywords
- quantitative systems pharmacology, biologic drugs, regulatory applications, drug development
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