Certara, Inc. Releases Simcyp™ PBPK Simulator Version 20
January 27, 2021 at 06:30 pm IST
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Certara, Inc. 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.
Certara, Inc. is a provider of biosimulation technology and solutions for using Model-Informed Drug Development in the global biopharmaceutical industry. It is focused on producing medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its customers include life sciences companies of all sizes along with contract research organizations, academic institutions, and global regulators. Its software and service are used by approximately 2,400 biopharmaceutical companies and academic institutions across 66 countries, including 38 of the top 40 biopharmaceutical companies. It has operations in the United States, Australia, Canada, China, France, Germany, India, Italy, Japan, Luxembourg, Netherlands, Philippines, Poland, Portugal, Spain, Switzerland, Egypt, and the United Kingdom.