12 January 2017 | News | By BioSpectrum Bureau
Simcyp Simulator is the industry-leading technology for predicting pharmacokinetic outcomes in virtual patient populations to streamline the drug development process
US based Certara (r), the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes has recently launched version 16 of its Simcyp (r) Population-based Simulator. This product 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.
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.
Steve Toon, President, Simcyp said, "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. 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."