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Simcyp™ PBPK Modeling Services

Global services team applying PBPK modeling to all stages in drug development

Proven expertise with Simcyp PBPK

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).

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.
Learn about our team

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.
Learn about Simcyp-informed drugs

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.
Learn about Simcyp offerings

Why choose Certara for PBPK modeling?

  • Certara delivers unparalleled expertise in PBPK modeling, combining regulatory-approved technology with a global team led by PhD-level professionals.
  • Our innovative solutions are trusted by regulators and biopharmaceutical companies worldwide to accelerate drug development, reduce costs, and improve patient outcomes.
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120
FDA-approved novel drugs supported using the Simcyp PBPK Simulator in lieu of clinical studies.
80
FDA label claims made with PBPK using the Simcyp PBPK Simulator.
200
Years of combined experience on the global Simcyp PBPK services team.
375
Published peer-reviewed papers from the Simcyp team since 2007.

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.

Connect with our team of experts

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.

Over 200 years of combined PBPK expertise.
Supported over 120 novel drug approvals.
Trusted by global regulatory agencies.

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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.