Modeling and Simulation Supports Dosing Guidelines for a Novel Treatment for Schizophrenia

A medium-sized biopharmaceutical company leveraged Certara’s trial simulation software and PBPK modeling and simulation consulting services to facilitate regulatory approval for a long- acting injectable antipsychotic drug.

Using a previously developed population PK model, they leveraged Certara’s Trial Simulator to perform Monte-Carlo simulations to evaluate different dosing scenarios including the impact of missing doses.