Simcyp Division, Certara UK Limited, Sheffield, UK.
CPT Pharmacometrics Syst Pharmacol. 2022 Jul;11(7):805-821. doi: 10.1002/psp4.12791. Epub 2022 Apr 18.
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.
Simcyp 模拟器是一个用于群体生理药代动力学（PBPK）建模和模拟的软件平台。它将体外数据与体内吸收、分布、代谢、排泄和药代动力学/药效学结果联系起来，以探索临床情况并支持药物开发决策，包括监管申报和药品标签。本教程描述了口服小分子药物在模拟器中开发 PBPK 模型所需的不同输入参数，以及开发 PBPK 模型时需要考虑的因素。本文使用一个奥丹赛酮 PBPK 模型的开发和应用案例研究来帮助理解不同的 PBPK 模型开发概念。
