Guide to development of compound files for PBPK modeling in the Simcyp population‐based simulator

Autor: Udoamaka Ezuruike, Mian Zhang, Amita Pansari, Mailys De Sousa Mendes, Xian Pan, Sibylle Neuhoff, Iain Gardner
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: CPT: Pharmacometrics & Systems Pharmacology, Vol 11, Iss 7, Pp 805-821 (2022)
Druh dokumentu: article
ISSN: 2163-8306
DOI: 10.1002/psp4.12791
Popis: Abstract The Simcyp Simulator is a software platform for population physiologically‐based pharmacokinetic (PBPK) modeling and simulation. It links in vitro data to in vivo absorption, distribution, metabolism, excretion and pharmacokinetic/pharmacodynamic outcomes to explore clinical scenarios and support drug development decisions, including regulatory submissions and drug labels. This tutorial describes the different input parameters required, as well as the considerations needed when developing a PBPK model within the Simulator, for a small molecule intended for oral administration. A case study showing the development and application of a PBPK model for ondansetron is herein used to aid the understanding of different PBPK model development concepts.
Databáze: Directory of Open Access Journals
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