A Step-by-Step Workflow for Performing In Silico Clinical Trials With Nonlinear Mixed Effects Models.

ABSTRACT: In silico clinical trials (ISCT) are computational frameworks that employ mathematical models to generate virtual patients and simulate their responses to new treatments, treatment regimens, or medical devices via simulations mirroring real-world clinical trials. ISCTs are an important component of the model-informed drug development (MIDD) framework for optimizing therapies, treatment personalization, informing regulatory decisions, and accelerating overall drug development by enhancing R&D productivity. However, the emergence of complex models, such as quantitative systems pharmacology (QSP) models, presents significant challenges for their effective implementation. Guidelines for conducting ISCTs have been published to address these challenges, focusing on algorithms and credibility fra

SUBMITTER: Cortes-Rios J 

PROVIDER: S-EPMC12706418 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature