Current practices for QSP model assessment: an IQ consortium survey.

Autor: Chan JR; Global PKPD and Pharmacometrics, Eli Lilly and Company, Indianapolis, IN, 46285, USA. jrchan@lilly.com., Allen R; Worldwide Research, Development and Medical, Pfizer Inc. Kendall Square, Cambridge, MA, 02139, USA., Boras B; Worldwide Research, Development and Medical, Pfizer Inc.,, La Jolla, CA, 92121, USA., Cabal A; Eisai Inc., NJ, Nutley, USA., Damian V; GlaxoSmithKline, Collegeville, PA, 19426, USA., Gibbons FD; Takeda, Cambridge, MA, 02139, USA., Gulati A; Merck & Co. Inc., Rahway, NJ, USA., Hosseini I; Genentech Inc., South San Francisco, CA, 94080, USA., Kearns JD; Novartis Institutes for BioMedical Research, Cambridge, MA, 02139, USA., Saito R; Innovative Research Division, Mitsubishi Tanabe Pharma Corporation, Yokohama, Japan., Cucurull-Sanchez L; GlaxoSmithKline, Stevenage, Hertfordshire, UK., Selimkhanov J; Takeda Development Center Americas Inc., San Diego, CA, 92121, USA., Stein AM; Pharmacometrics, Novartis Institutes of BioMedical Research, Cambridge, MA, USA., Umehara K; Roche Pharmaceutical Research and Early Development, Basel, Switzerland., Wang G; Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Abingdon, Oxfordshire, UK., Wang W; Clinical Pharmacology and Pharmacometrics, Janssen Research and Development, LLC, Spring House, PA, 19477, USA., Neves-Zaph S; Data and Data Science, Translational Disease Modeling, Sanofi, USA.
Jazyk: angličtina
Zdroj: Journal of pharmacokinetics and pharmacodynamics [J Pharmacokinet Pharmacodyn] 2024 Oct; Vol. 51 (5), pp. 543-555. Date of Electronic Publication: 2022 Aug 11.
DOI: 10.1007/s10928-022-09811-1
Abstrakt: Quantitative Systems Pharmacology (QSP) modeling is increasingly applied in the pharmaceutical industry to influence decision making across a wide range of stages from early discovery to clinical development to post-marketing activities. Development of standards for how these models are constructed, assessed, and communicated is of active interest to the modeling community and regulators but is complicated by the wide variability in the structures and intended uses of the underlying models and the diverse expertise of QSP modelers. With this in mind, the IQ Consortium conducted a survey across the pharmaceutical/biotech industry to understand current practices for QSP modeling. This article presents the survey results and provides insights into current practices and methods used by QSP practitioners based on model type and the intended use at various stages of drug development. The survey also highlights key areas for future development including better integration with statistical methods, standardization of approaches towards virtual populations, and increased use of QSP models for late-stage clinical development and regulatory submissions.
Competing Interests: Declarations Competing interests The authors declare no competing interests. Conflict of interest The authors declare no competing interests.
(© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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