Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
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The Simcyp® In Vitro Data Analysis Toolkit (SIVA) is a software solution that enables 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. The SIVA Toolkit platform is designed 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 (PBPK) models. It is a standalone product and can be purchased independently of Certara’s Simcyp Simulator. With the SIVA Toolkit, researchers can: