Our global team of PhD-level professionals are here to bring unparalleled expertise to your project. We leverage a proven track record in PBPK modeling to help you leverage mechanistic modeling for critical applications such as first-in-human (FIH) dose predictions, drug-drug interactions (DDIs), dosing for specific populations, and virtual bioequivalence (VBE).
Simcyp™ PBPK Modeling Services
Global services team applying PBPK modeling to all stages in drug development
Predict clinical outcomes from virtual populations
Proven expertise with Simcyp PBPK
Trusted expertise
- Our global services team has 200+ years of combined experience in supporting drug development and regulatory approval processes using the Simcyp PBPK Simulator.
- Our team of 40+ consultants has expertise across a range of applications and are available to support your projects.
Regulatory success
- Trusted by regulators, more than 120 FDA-approved novel drugs used the Simcyp PBPK Simulator in lieu of clinical trials.
- More than 80% of all FDA label claims leveraging PBPK in the last 5 years were supported by Simcyp solutions and the services team.
Gold standard technology
- Certara’s Simcyp PBPK Simulator is the industry-leading software platform for PBPK modeling.
- 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.
Certara's innovative PBPK modeling solutions
Simcyp PBPK is the go-to solution for drug-drug interaction (DDI) analyses
DDI trials are expensive and time consuming. If your drug is metabolized by CYP3A, there is a high likelihood that our Simcyp offerings can be used to replace at least one DDI study.
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Certara’s Simcyp PBPK modeling services are key to streamlining drug development. Our expert team is ready to collaborate with you to deliver innovative, evidence-based solutions tailored to your needs.
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Simcyp PBPK modeling FAQs
What is PBPK modeling?
PBPK modeling uses advanced simulations to predict the pharmacokinetics of drugs in virtual populations, supporting drug development and regulatory decisions.
How does Simcyp PBPK reduce clinical trial costs?
By replacing or reducing the need for in vivo studies, Simcyp PBPK eliminates unnecessary trials and accelerates timelines.
Can Simcyp PBPK address specific populations?
Yes, Simcyp PBPK can be used to model drug behavior in pediatrics, geriatrics, organ-impaired patients, and other unique populations.