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Simcyp

Advanced technology solutions support all PBPK applications across drug development

Simcyp PBPK Simulator Version 24 is now available

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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.

Discovery

IND

Preclinical

Early clinical (human volunteers)

NDA

Late clinical (patient data)

Post-marketing

Simcyp Simulator – DMPK scientists, clinical pharmacology and pharmacometricians

Simcyp Discovery – discovery and early development

Simcyp Biopharmaceutics – biopharmaceutic, formulation and CMC scientists

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.

A 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

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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