Simcyp

Simcyp® is Certara's industry-leading physiologically based pharmacokinetic (PBPK) modeling and simulation platform, designed to predict drug behavior in diverse populations across all stages of drug development. It provides a seamless, mechanistic modeling environment that reduces reliance on extensive in vivo studies, supporting applications from early discovery through post-marketing. Simcyp is the most widely adopted PBPK platform in drug development, built over 25 years in collaboration with 37 of the top global pharmaceutical companies, and is trusted by DMPK scientists, clinical pharmacologists, pharmacometricians, biopharmaceutics experts, and formulation scientists alike.

As a testament to its scientific credibility and regulatory acceptance, Simcyp is licensed by 11 regulatory agencies worldwide, and more than 120 novel drugs approved by the FDA have used the Simcyp Simulator in lieu of clinical studies. The platform has earned EMA Qualification and is cited in the European Journal of Pharmaceutical Sciences as the leading platform for PBPK modeling in novel FDA-approved drugs, holding over 80% market share among comparable tools.

Key PBPK Applications Supported

• Label claims in lieu of clinical studies
• Drug-drug interaction (DDI) screening
• Special population modeling, including organ impairment
• Formulation and virtual bioequivalence analysis
• First-in-human dose prediction

Flagship Platform Components

• Simcyp PBPK Simulator: The standard for population-based physiologically based modeling and simulation, used from preclinical through post-marketing stages by DMPK scientists, clinical pharmacologists, and pharmacometricians.
• Simcyp Biopharmaceutics: An advanced PBPK platform tailored for biopharmaceutics, formulation, and CMC experts, supporting preclinical through post-marketing applications.
• Simcyp Discovery: An advanced PBPK platform focused on pre-IND success, supporting screening, first-in-human dose prediction, early DDI assessments, and formulation decisions during discovery and early development phases.

Additional Offerings and Capabilities

• Physiologically based pharmacokinetic modeling to predict drug behavior across diverse patient populations
• Streamlined in vitro data analysis of whole cell systems and dissolution studies to feed into PBPK modeling
• Prediction and analysis of off-target risks in drug development for safer outcomes
• Global consulting services applying PBPK modeling across all stages of drug development

Regulatory Support and Collaboration

• Licensed and adopted by 11 global regulatory agencies
• Certara's team maintains regular communication and collaboration with global regulatory agencies to provide comprehensive, up-to-date regulatory support
• Proven track record supporting streamlined regulatory submissions and label claims without additional clinical studies
• EMA Qualification achieved, reinforcing the platform's regulatory credibility

Scientific Leadership and Expert Team

• Supported by a renowned global team of PBPK consultants and scientists providing leading-edge client support
• Chief Scientific Officer Amin Rostami-Hodjegan, PhD, leads integration of the latest translational modeling advances into the platform
• SVP Hannah Jones, PhD, brings over 20 years of pharmaceutical experience and more than 70 publications in PBPK/PKPD modeling
• SVP Masoud Jamei, PhD, leads a team of 50 scientists and 35 software developers focused on systems pharmacology model design and implementation
• Senior Scientific Advisor Iain Gardner, PhD, leads science teams developing and enhancing population-based physiologically based PK/PD simulators
• SVP Karen Rowland Yeo, PhD, brings over 20 years of PBPK expertise across therapeutic areas and more than 100 publications

Simcyp is developed and maintained by Certara, a global organization with over 1,550 employees across more than 30 countries. The platform integrates with Certara's broader suite of drug development solutions and consulting services, offering a unified, end-to-end environment for model-informed drug development from molecule to market.