In the wake of the December 2008 FDA Guidance for Industry on cardiovascular safety assessments, Dr. Rick Turner began to consider how cardiac and cardiovascular safety could be integrated in assessing products in development. In this presentation from the October 2009 DIA webinar on cardiac safety, he outlines his model to prospectively rule out unacceptable cardiovascular safety risk. The model is structured around three components: clinical science, regulatory science and statistical science. Turner’s discussion centers on the development of new antidiabetic drugs for the treatment of Type 2 diabetes mellitus.
Presentation December 14, 2009