This blog explains how Clarus Therapeutics utilized M&S to improve their Phase 3 study design and ultimately gain FDA approval for their product.
https://www.certara.com/blog/using-phoenix-nlme-trial-simulator-to-design-a-phase-3-study-to-obtain-fda-approval/Get started today! Reviewers are often tasked with quickly approving eCTD submission content and fielding agency questions on the fly, which requires referencing in-stream as well as historical submissions. The trouble is, without the right eCTD viewing solutions in place, simple yet critical review tasks can cause delays, increasing your risk of rejection, costs, and … Continued
https://www.certara.com/globalsubmit-freetrial/By Yuancheng Chen, Research Associate of Phase 1 Unit, Huashan Hospital, Fudan University, and visiting scholar of Uppsala University Certara recently held its first virtual Phoenix User Group meeting in China. Over this three-day meeting, attendees learned from Certara’s experts on specific Phoenix workflow examples, updates to the Phoenix product roadmap, an overview the latest … Continued
https://www.certara.com/blog/application-of-pk-pd-modeling-and-simulation-in-drug-discovery-and-development-in-china/It’s hard to imagine that 37 leading, global biopharmaceutical companies would be willing to partner to develop a new technology and progress a scientific field, but that is exactly what the members of the Simcyp Consortium have achieved. Working together in a pre-competitive, collaborative research environment, the consortium’s members are advancing physiologically based pharmacokinetic (PBPK) … Continued
https://www.certara.com/article/pre-competitive-research-propels-modernization-of-drug-development-using-modeling-and-simulation/Each day, we wake up hoping for positive news about vaccines and therapies to combat COVID-19. More than 70 candidate molecules are being evaluated for repurposing to treat COVID-19. This number will grow thanks to the use of new combination therapies discovered under an aggressive, disciplined, and quantitative approach to evaluating candidates called model-informed drug development (MIDD)…
https://www.certara.com/article/addressing-the-covid-19-challenge-with-computer-modeling-simulation/Research Database to Quantify Impact of Potential COVID-19 Treatments,
with Results from Over 500 Clinical Trials and Observational Studies Over the Next Three Months
