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This paper compares the performances of Poisson, zeroinflated poisson (ZIP), negative binomial (NB), and zero-inflated NB (ZINB) mixed-effects regression models in fitting lesion count data in a clinical trial evaluating the efficacy and safety of fingolimod in comparison with placebo, in MS...… Read more
This presentation was given by Rene Bruno, Managing Director, Europe, Certara, at the Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting in March, 2012.… Read more
This presentation was given by David R. Lowis, D. Phil., Senior Director of Product Management, Certara, at the Global Discovery & Development Innovation Forum (GDDIF) in March, 2012, where he discussed the need for consolidation of data from multiple disciplines, providing a more holistic view of the patient, disease, treatment and underlying science, to support translational science initiatives.… Read more
This recorded webinar presents general principles of modeling and simulation to optimize pediatric trial design and support dosing rationale to ensure adequate safety and efficacy of treatments intended for pediatric use. Both “top-down” and “bottom-up” approaches are discussed as part of a modeling framework to better understand and predict complex drug and system dynamics. The session includes case examples of these synergistic approaches in a shared clinical indication.… Read more
In this case study, we review the challenges scientists at a small biotech company consistently experienced when attempting to access and merge their chemistry and biology data, which were stored in different systems, and after deploying Certara's D360, were able to free the time of scientists who were formerly charged with data extraction duties to best make use of their scientific capabilities.… Read more