Certara, a Princeton, N.J.-based, global biosimulation technology-enabled drug development company, launched its Simcyp In Vitro (Data) Analysis (SIVA) Toolkit, version 1.0. The SIVA Toolkit is designed to enable the analysis of complex in vitro studies, including those with whole cells, tissue samples and solid dosage forms. It combines the latest model-based data analysis approaches to assess the metabolism, transport or dissolution/solubility of drugs with powerful optimization algorithms in a sophisticated statistical environment. This approach ensures that users do not need to have extensive modeling or statistical experience to use the toolkit.
“Analysis of in vitro data from whole cell systems and dissolution studies is challenging and time-consuming, and yet it is crucially important to have accurate data analysis and informed data interpretation early in the drug development process when key decisions need to be made,” said Edmundo Muniz, M.D., Ph.D., Certara chief executive officer.
“The SIVA Toolkit platform is designed specifically to analyze complex in vitro data, providing accurate values for parameters that can subsequently be used in in vitro-in vivo extrapolation paradigms that are necessary to successfully predict in vivo behavior of drugs in physiologically-based pharmacokinetic models,” added Muniz.
The SIVA Toolkit also can be used to provide reliable in vitro data for decision trees in regulatory guidelines, mechanistic-static or static models. It is a stand-alone product and can be purchased independently of Certara’s Simcyp Simulator. It will be useful for researchers analyzing experimental data in the pharmaceutical industry, universities and CROs.