Certara Launches Its Simcyp In Vitro (Data) Analysis Toolkit to Improve Drug Discovery and Development Study Results
PRINCETON, NJ – July 29, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced the launch of 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 Certara Chief Executive Officer Edmundo Muniz, M.D., Ph.D.
“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 Dr. Muniz.
The SIVA Toolkit can also be used to provide reliable in vitro data for decision trees in regulatory guidelines, mechanistic-static or static models. It is a standalone 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 contract research organizations.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Phase II ALPACA Trial Shows Lepodisiran Produces Significant, Sustained Lipoprotein(a) Reductions
March 31st 2025Eli Lilly’s lepodisiran, an investigational siRNA therapy, achieved significant and durable reductions in lipoprotein(a) levels, a major genetic risk factor for cardiovascular disease.
