Certara.SimcypVBE

Overview

Simcyp^TM is a Physiologically Based Pharmacokinetic (PBPK) simulation platform that accurately predicts drug behavior within the human body using complex mechanistic models involving demographics, developmental physiology, and drug elimination pathways, along with advanced mechanistic organ models and compound files. Virtual Bioequivalence (VBE) is a simulation based method for evaluating/demonstrating bioequivalence between a reference and test formulation in lieu of running clinical BE study. In addition, VBE can be used to inform the BE study design or complement it where possible.

Features include:

• Integration with Simcyp^TM V23 Simulator Engine for extensible R based VBE workflows

• Shiny UI accessible in Pirana v24.9.1 for performing sensitivity analysis and full simulations of virtual populations for Long Acting Injectables (LAI)

• Project is shareable, reproducible, and self-contained within .vbe file

Installation

install.packages( 
  "Certara.SimcypVBE", 
  repos = c("https://certara.jfrog.io/artifactory/certara-cran-release-public/",  
  "https://cloud.r-project.org"),
  method = "libcurl")

Acknowledgements

This package was developed with support from the U.S. Food and Drug Administration (FDA) through the grant 1U01FD007904-01, titled “A State-of-the-Art Virtual Bioequivalence Platform and Case Studies on Complex Formulations, Systemic and Local Concentration-based Bioequivalence”.