Unique capabilities expand the types of drugs, modalities, populations, and development questions modeled using the Simcyp PBPK Simulator
PRINCETON, NJ.— 2021 年 1 月 27 日– Certara, Inc., the global leader in biosimulation, today announced the release of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator platform. Simcyp PBPK Simulator version 20 provides new models for maternal health, virtual bioequivalence to attain biowaivers, and analysis of long-acting injectable drugs. It also delivers a newly expanded biologics module, Simcyp Biologics Simulator, that enables scientists to model a wider range of biologic modalities to accelerate drug development.
Certara’s industry-leading Simcyp PBPK Simulator improves clinical trial efficiency and outcomes through the modeling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) using virtual patient populations. The Simcyp PBPK Simulator’s in silico models have informed the label claims of more than 75 novel FDA-approved drugs, reducing the need to conduct human clinical studies. This mechanistic modeling approach, developed over the past 20 years, is well established in predicting the PK of small molecules and is now increasingly being applied to biologic drug development.
Simcyp PBPK Simulator version 20 offers new and enhanced models for maternal health, such as assessing drug performance during pregnancy and lactation. It also automates the assessment of virtual bioequivalence to attain biowaivers and analyzes drugs delivered via long-acting injectable delivery. Additional upgrades have been made to the Simcyp PBPK Simulator’s animal, liver, absorption, and skin models.
“We are thrilled to offer new capabilities that accelerate modern drug development with the launch of our latest Simcyp Simulator,” said William F. Feehery, Ph.D., chief executive officer of Certara. “Our Simcyp team, working with the world’s most innovative biopharmaceutical companies, has expanded the applicability of PBPK modeling and simulation to advance small molecules and biologics in key therapeutic areas such as oncology, autoimmune diseases, and rare diseases.”
The expanded Simcyp Biologics Simulator delivers first-in-human PK prediction and dose selection, target selection and validation by linking PK to pharmacology, tumor penetration of proteins, target shedding, and the impact on tumor receptor occupancy. Pharmacokinetic properties of biologics are structurally complex, requiring specific mechanistic models to explore potential clinical complexities before human testing. Simcyp Biologics Simulator is also available as a standalone software.
“The information and conclusions generated by Simcyp Biologics Simulator will support mission critical decisions as customers look to optimize a biologic drug’s safety and efficacy profile,” said Masoud Jamei, Ph.D., senior vice president of research and development of Certara’s Simcyp division. “To support these advanced medicines, which comprise 40% of the global biopharmaceutical R&D pipeline, Certara has broadened access to Simcyp Biologics Simulator by offering it as a standalone software.”
For more information, please visit: https://www.certara.com/software/simcyp-pbpk/.
Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
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