Certara's Physiologically-Based Pharmacokinetic Modeling (PBPK) Solutions

  • The Simcyp® Simulator is the industry’s premier Physiologically-Based Pharmacokinetic (PBPK) software platform for modeling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) in virtual populations. It is used by pharmaceutical, veterinary, and academic researchers, along with the F.D.A. and other global regulatory agencies, to understand the safety and efficacy profile of drugs in development. It is the gold standard for predicting drug-drug interactions and pharmacokinetic outcomes in clinical populations.
  • The Simcyp Pediatric Simulator allows pharmacokinetic behavior to be modeled in neonates, infants, and children. It is a module within the Simcyp Population-based Simulator, which is licensed to members of the Simcyp Consortium of leading pharmaceutical and biotechnology companies.
  • Simcyp Animal is a whole-body PBPK modeling platform for rat, dog, and knock-out mouse. When used with the Simcyp Population-based Simulator, Simcyp Animal allows comparison of human and animal data without relying upon allometric scaling, which may not be a valid approach for some parameters
  • The Cardiac Safety SimulatorTM (CSS) is a software tool that integrates mechanistic PBPK modeling and simulation with a heart muscle cell model to predict the cardiac effects of drugs. CSS uses available in vitro data to simulate in vivo effects.
  • The Simcyp In Vitro (Data) Analysis (SIVATM) Toolkit is a software solution that enables the analysis of complex in vitro studies, including those with whole cells, tissue samples and solid dosage forms. It combines the latest model-based data analysis approaches to assess the metabolism, transport or dissolution/solubility of drugs with powerful optimization algorithms in a sophisticated statistical environment.