Simcyp Simulator is the industry-leading technology for predicting pharmacokinetic outcomes in virtual patient populations to streamline the drug development process
Certara®, the leading provider of decision support technology and consulting services for optimising drug development and improving health outcomes, has announced that it has released version 16 of its Simcyp® Population-based Simulator.
The Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations, and predicting drug-drug interactions (DDIs) and pharmacokinetic (PK) outcomes in clinical populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function.
The Simcyp Simulator is also frequently used to inform drug label language and has regulatory acceptance from the US Food and Drug Administration (FDA), the European Medicines Agency, and the Japanese Pharmaceuticals and Medical Devices Agency.
For example, the Simcyp Simulator has been leveraged to inform more than 100 label claims for new drug approvals from FDA in the past few years. These label additions include potential DDIs, dosing regimens, and data about new populations.
“The Simcyp Simulator is playing such a pivotal role at all stages of the drug development and regulatory process that our annual system update has become a major event,” said Simcyp President Steve Toon, PhD. “We are proud to introduce significant enhancements to our lung, skin, and gastrointestinal (GI) tract models this year as well as time-saving administrative tools such as the Simcyp Report Assistant.”
Most of the top-40 pharma companies (including all of the top 10) are members of the Simcyp Consortium, which requested these new product developments.
Simcyp’s whole body simulation methodology can predict the PK and pharmacodynamics (PD) of small molecule and biological medicines using laboratory-derived data. The simulator includes a unique set of genetic, physiological and epidemiological databases that facilitate the simulation of virtual populations with different demographics and ethnicities.
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In addition, the Simcyp Simulator parameter estimation and sensitivity analysis capabilities are extensively expanded and it now provides biologics models and a biologics database for its Monkey Simulator.
Further information about Simcyp Simulator v16 is available at www.certara.com/software/pbpk-modeling-and-simulation/simcyp-simulator/. Simcyp Simulator v16 can also be downloaded now.