No Recipe for Quantitative Systems Pharmacology Model Validation, but a Balancing Act Between Risk and Cost-Reference-Cited by-同舟云学术

No Recipe for Quantitative Systems Pharmacology Model Validation, but a Balancing Act Between Risk and Cost

Published:2023-11-09 Issue:1 Volume:115 Page:25-28
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Lemaire Vincent¹^ORCID,Hu Chuanpu²^ORCID,van der Graaf Piet H.³,Chang Steve⁴,Wang Weirong⁵

Affiliation:

1. Clinical Pharmacology Genentech South San Francisco California USA

2. Clinical Pharmacology, Pharmacometrics, Disposition and Bioanalysis Bristol Myers Squibb Princeton New Jersey USA

3. Canterbury Innovation Centre Certara Canterbury UK

4. Immunetrics, Inc. Pittsburgh Pennsylvania USA

5. Janssen R&D Spring House Pennsylvania USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.3082

Reference13 articles.

1. Model-based Drug Development

2. Achieving end-to-end success in the clinic: Pfizer’s learnings on R&D productivity

3. Sorger P.K.et al.Quantitative and systems pharmacology in the post‐genomic era: new approaches to discovering drugs and understanding therapeutic mechanisms(2011). In An NIH white paper by the QSP workshop group (Vol. 48 pp. 1‐47). Bethesda MD: NIH.https://pharmaceutical.report/Resources/Whitepapers/fca8a762‐30c7‐4d49‐a04c‐3b97a266db3c_SystemsPharmaWPSorger2011.pdf.

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

5. FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective