Virtual bioequivalence (VBE) replaces the need for costly and time-consuming clinical trials by using Simcyp PBPK modeling. This approach expedites regulatory approval, reduces costs, and ensures faster delivery of safe, effective drugs to patients. By employing advanced modeling techniques, Certara helps pharmaceutical companies achieve success with confidence and precision.
Simcyp™ Virtual Bioequivalence
Demonstrate bioequivalence with PBPK modeling in lieu of clinical studies
Learn more about virtual bioequivalence
Transforming drug development with virtual bioequivalence
Regulatory-approved waivers
Our VBE services have successfully enabled waivers for bioequivalence studies, saving both time and resources.
Efficient formulation development
Simulate new formulations and alternative drug delivery methods for informed decision-making.
Powered by Simcyp
The Simcyp Simulator has an expanded VBE module to simulate various VBE studies for oral and dermally applied drugs.
Regulatory success
The first FDA-approved complex topical generic used Simcyp to prove bioequivalence.
Driving innovation in virtual bioequivalence
Meet our experts
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Experts
Sebastian Polak, PhD
Senior Scientific Advisor & Head of Mechanistic Dermal Modeling
Sebastian leads the development of dermal models and cardiac safety modeling and simulation system. He is also a tenured Professor in Biopharmaceutics at the Faculty of Pharmacy at Jagiellonian University in Krakow, Poland.
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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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Explore the benefits of Certara’s virtual bioequivalence services today. Our team of experts are ready to help you navigate the complexities of bioequivalence studies and achieve regulatory success.
Proven success is securing FDA bioequivalence approvals.
Access to world-class expertise in PBPK modeling
Innovative solutions tailored to your drug development needs.
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Virtual bioequivalence FAQs
What is virtual bioequivalence (VBE)?
VBE uses PBPK modeling to demonstrate bioequivalence, eliminating the need for clinical trials.
Which regulatory bodies accept virtual bioequivalence data?
Certara’s VBE services comply with FDA, EMA, and other major global regulatory requirements.
What types of drugs can benefit from virtual bioequivalence?
VBE applies to oral, intravenous, and dermal drug formulations, including complex generic drugs.
