The Simcyp PBPK Simulator is the industry leader and most widely adopted platform for PBPK modeling in drug development. Developed through the expertise of a 25 year-long consortium involving 37 leading global pharmaceutical companies, the Simcyp PBPK Simulator is recognized and licensed by 11 regulatory agencies worldwide. Our Simcyp offerings are backed by a dedicated research and development team as well as a team of global PBPK consultants, ensuring comprehensive support for clients.
Simcyp™ PBPK Simulator
Leading the way in population-based physiologically based modeling and simulation
Learn more about the Simcyp PBPK Simulator
11
Global regulatory agencies that use the Simcyp PBPK Simulator
120
FDA-approved novel drugs supported using the Simcyp PBPK Simulator in lieu of clinical studies
80
FDA label claims made with PBPK used the Simcyp platform
Key features
The Simcyp PBPK Simulator predicts drug behavior within the human body, aiding in various stages of drug development. This includes determining optimal dosing for first-in-human trials, optimizing clinical study designs, evaluating new drug formulations, predicting drug-drug interactions, and conducting virtual bioequivalence analyses.
- Extensive libraries on demographics, developmental physiology, and drug elimination pathways.
- Advanced mechanistic organ models and compound files.
- Integrates in vitro data with in vivo outcomes to support informed decision making.
- Virtual population simulations reflect diverse demographics, ethnicities, and disease states.
- Includes 29 population libraries and over 100 small and large molecule models.
- Availability to support compound and population verification documents for regulatory submissions.
Contact us
Simcyp expansions
We offer several specialized modules for the Simcyp PBPK Simulator. From predicting pediatric dosing to evaluating cardiac safety and bioavailability, we offer solutions to meet your unique challenges.
Advantages of using the Simcyp PBPK Simulator
Our Simcyp PBPK experts
1 / 5
Experts
Amin Rostami-Hodjegan, PhD, FCP, FAAPS, FJSSX, FBPS
Chief Scientific Officer and SVP of R&D
Amin facilitates the incorporation and integration of the latest advances in translational modeling to biosimulation platforms offered by Certara to its clients, with the aim of accelerating the development and regulatory approval of safer drug products and bringing them to the patients.
Connect
2 / 5
Experts
Masoud Jamei, PhD
SVP, Simcyp Research and Development
Masoud Jamei has over 20 years of experience and currently leads a team of 50 scientists and 35 software developers and testers focusing on the design, development, and implementation of systems pharmacology models
Connect
3 / 5
Experts
Iain Gardner, PhD
Sr. Scientific Advisor and Head of Translational Science
With over 20 years of experience, Iain currently leads the science team that is responsible for developing and enhancing population-based physiologically-based PK/PD simulators for Simcyp Consortium members.
Connect
4 / 5
Experts
Karen Rowland Yeo, PhD
SVP, Client & Regulatory Strategy
Karen has over 20 years of expertise in applying PBPK modeling in global health and drug development settings across many therapeutic areas. She has over 100 publications and also serves as the Deputy-Editor-in-Chief of the CPT: Pharmacometrics & Systems Pharmacology journal.
5 / 5
Experts
Hannah Jones, PhD
SVP, Head of Simcyp PBPK Modeling Services
Hannah has over 20 years of experience in global pharmaceutical organizations, possessing a particularly strong background in PBPK and PKPD modeling. She has over 70 publications in PBPK/PKPD modeling and other DMPK related topics, and considerable experience influencing drug research and development programs through modeling and simulation.
ConnectRelated resources
View allRelated solutions
Simcyp workshops
Simcyp workshops equip you with the tools to integrate compound-specific in vitro and in vivo data with system-level understanding, enabling precise simulations and predictions of drug behavior across various populations.
Whether you’re preparing Investigational New Drug (IND) applications or refining clinical trial designs, Simcyp workshops are designed to help you improve the quality of your regulatory submissions and achieve better clinical outcomes.
PBPK modeling software you can trust
Schedule a demo or consultation to see how the Simcyp PBPK Simulator can empower your team.
Proven track record: 120+ novel drugs have used the Simcyp PBPK Simulator in lieu of clinical studies
Scientific expertise: Developed through the expertise of a 25 year-long consortium involving 37 leading global pharmaceutical companies
Global impact: Licensed by 11 global regulatory agencies
