A generic framework for the physiologically-based pharmacokinetic platform qualification of PK-Sim and its application to predicting cytochrome P450 3A4-mediated drug-drug interactions.
Journal
CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
revised:
08
03
2021
received:
30
12
2020
accepted:
01
04
2021
pubmed:
5
5
2021
medline:
22
1
2022
entrez:
4
5
2021
Statut:
ppublish
Résumé
The success of applications of physiologically-based pharmacokinetic (PBPK) modeling in drug development and drug labeling has triggered regulatory agencies to demand rigorous demonstration of the predictive capability of the specific PBPK platform for a particular intended application purpose. The effort needed to comply with such qualification requirements exceeds the costs for any individual PBPK application. Because changes or updates of a PBPK platform would require (re-)qualification, a reliable and efficient generic qualification framework is needed. We describe the development and implementation of an agile and sustainable technical framework for automatic PBPK platform (re-)qualification of PK-Sim
Identifiants
pubmed: 33946131
doi: 10.1002/psp4.12636
pmc: PMC8213412
doi:
Substances chimiques
Cytochrome P-450 CYP3A
EC 1.14.14.1
CYP3A4 protein, human
EC 1.14.14.55
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
633-644Informations de copyright
© 2021 Pharmacometrics/Modeling & Simulation, Research & Development, Pharmaceuticals, Bayer AG. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
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