Simcyp™
Advanced technology solutions support all PBPK applications across drug development
Simcyp PBPK Simulator Version 24 is now available
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Learn more about the Certara Simcyp solutions
Predictive modeling technology across the drug development cycle
PBPK modeling is a mechanistic modeling approach increasingly adopted across all stages of drug development. Simcyp provides a seamless PBPK modeling environment for all stages of drug development, reducing the reliance on extensive in vivo studies.
As the most widely adopted platform for PBPK modeling in drug development, Simcyp is the only technology solution suite developed in collaboration with 37 of the top global pharmaceutical companies over the last 25 years. A testament to its leadership in PBPK, Simcyp is licensed by 11 regulatory agencies worldwide and over 120 novel drugs approved by the FDA used Simcyp in lieu of clinical studies.
Label claims in lieu of clinical studies
Drug-drug interaction screening
Special population modeling, including organ impairment
Formulation and virtual bioequivalence analysis
First-in-human dose prediction
PBPK modeling tools for confident decision making
Simcyp offers a comprehensive suite of PBPK modeling solutions, including three flagship platforms: Simcyp PBPK Simulator, Simcyp Biopharmaceutics, and Simcyp Discovery. Together, these solutions provide a seamless modeling environment for PBPK modeling from discovery through post-marketing. In addition, Simcyp is supported by a renowned team of PBPK consultants and scientists globally, ensuring comprehensive and leading-edge support for clients.
- Simcyp PBPK Simulator: the standard for population-based physiologically based modeling and simulation
- Simcyp Biopharmaceutics: advanced PBPK platform for biologic formulation
- Simcyp Discovery: advanced PBPK platform for pre-IND success
Simcyp: Preferred PBPK Platform
80.5
Simcyp
11.7% ND
2.6% PK-Sim
5.2% GastroPlus
“Simcyp is the leading platform for PBPK modeling in novel drugs approved by the FDA over the past five years.”
European Journal of Pharmaceutical Sciences
Trusted expertise and proven results
11
global regulatory agencies have adopted Certara Simcyp.
120
novel drugs using the Simcyp Simulator in lieu of clinical studies.
25
years advancing PBPK via industry-leading scientific development and collaboration.
Simcyp's impact on drug development
Meet our 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.
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2 / 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.
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3 / 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.
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4 / 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.
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5 / 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.
ConnectA unified solution for all stages of development
Understanding a drug’s PK spans multidisciplinary teams, from DMPK to regulatory. Simcyp enables integration across these functional areas, ensuring:
- Accurate IND-enabling studies
- Regulatory-accepted predictions while minimizing clinical trials
- Validated compound and population models
“The PBPK consulting team delivered top-quality outputs, and their turnaround time was exceptional, and I especially appreciate the extra effort they put into accommodating our tight deadlines. They went above and beyond to ensure our success.”
Vassilios Aslanis
Vice President – Head of Clinical Pharmacology at Sudo Biosciences
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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.
A PBPK modeling platform you can trust
Schedule a demo or consultation to see how Simcyp 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
Discover PBPK applications
Predicting drug performance
Explore how the Simcyp PBPK Simulator accurately predicts drug behavior across diverse patient populations and scenarios.
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Drug formulation with Simcyp
Discover advanced PBPK modeling applications to streamline drug formulation and approval using the Simcyp PBPK Simulator.
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Developing population files
Learn best practices for creating population files for PBPK modeling with the Simcyp PBPK Simulator.
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