Product will serve as a data source for D360, supporting ongoing study monitoring and cross-study analyses ST. LOUIS, MO – 2014年4月29日 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, announced today the launch of its Pre-clinical Safety Store (PCSS). A companion product to D360, Certara’s integrated solution for the … Continued
Purchase adds global regulatory writing and submission services to Certara’s drug development consulting expertise ST. LOUIS, MO – 2014年4月15日 – Certara™, the leading technology-enabled drug development and drug safety consultancy, announced today that it has acquired specialty contract research organization (CRO) Synchrogenix Information Strategies Inc. Synchrogenix offers regulatory writing and related services to … Continued
Model-based drug development in oncology is still lagging despite a good momentum in the clinical pharmacology and pharmacometry community in the past few years. The failure rate of late-stage oncology studies is one of the highest across therapeutic areas. The modeling of the relationship between longitudinal tumor size and overall survival has been proposed to … Continued
The motesanib phase III MONET1 study failed to show improvement in overall survival (OS) in non–small cell lung cancer, but a subpopulation of Asian patients had a favorable outcome. We performed exploratory modeling and simulations based on MONET1 data to support further development of motesanib in Asian patients. A model-based estimate of time to tumor … Continued
