New release further expands biologics capabilities and provides new tools for formulation scientists
ST. LOUIS, MO – Aug. 28, 2013 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, today announced that version 13 of its Simcyp™ Simulator has now been released, which permits the quantitative prediction of drug-drug-interactions and pharmacokinetic-pharmacodynamic outcomes in virtual populations. The latest platform strengthens Simcyp’s position as the leading provider of translation tools for connecting pre-clinical ADMET data to clinical outcomes using modeling and simulation.
Simcyp has extended its model repertoire for biologics by incorporating a full physiologically-based pharmacokinetic (PBPK) model for monoclonal antibodies and therapeutic proteins with significant practical applications. In addition, the inclusion of a non-linear plasma protein and red blood cell binding facility in version 13 addresses a level of complexity that is regularly needed for modeling in the oncology arena. The integration of a novel sophisticated IVIVC tool to handle in vitro – in vivo correlations of dissolution for various solid oral dosage forms enhances the scope of the simulator in the divisions of Formulation and Pharmaceutics.
Commenting on the new release, Professor Amin Rostami, vice president of research and development at Simcyp, said: “The expanding scientific expertise and diversity of specialties within Simcyp R&D over the last few years have enabled us to address many different areas that Consortium member companies were interested in. The latest release is a clear manifestation of the breadth and depth of knowledge within the team who fully complement each other.”
Reflecting on the expansion of the model repertoire for generic manufacturers and companies focusing on biologics, Dr Steve Toon, vice president of consulting services and technical sales support at Simcyp, commented: “Simcyp continues to enhance and evolve its products and services in line with the changing face of the pharmaceutical industry. With many of our Consortium member companies’ growing interest in biologics and increasing requests for consultancy support from the biotech and generics communities, the enhanced features within version 13 keep Simcyp at the forefront of PBPK modeling and simulation research, science, products and consultancy services.”
Version 13 of the Simcyp Simulator is now available to all Consortium members and academic associates with current not-for-profit license agreements.
Simcyp provides platforms for the modeling and simulation of pharmacokinetics and pharmacodynamics in virtual human populations and virtual laboratory animals (rat, dog and mouse). The technology allows pharmaceutical researchers to predict in vivo outcomes from routinely generated in vitro data, to fit Simcyp models to observed clinical data and to assess inter-individual variability through ‘real-life’ simulations. Simcyp also runs educational workshops, on-site education and provides strategic consultancy in drug development. For more information, visit www.simcyp.com.
Certara is dedicated to improving human health by delivering a broad spectrum of software products and consulting services, spanning molecular discovery to clinical development, with special focus on supporting translational approaches to drug development. A leading provider of model-based drug development tools, Certara was formed by the acquisition and integration of industry leaders Tripos®, Simcyp™, and Pharsight® Corporation. Each Certara family brand focuses on a key phase within the drug discovery and development process; combined, they offer a unique set of scientific modeling, analysis, and simulation capabilities that can enable the cross-disciplinary approaches necessary for translational science initiatives. For more information, visit www.certara.com.
Representatives from Simcyp are available on request.
Phone: +44 (0)114 292 2337