Lewis B. Kinter, Ph.D., Senior Director: Regulatory Toxicology, and Head Toxicological Operations, Safety Assessment (US), AstraZeneca Pharmaceuticals, spoke at last year's Exploratory Clinical Development World. I thought you might be interested in downloading his presentation on âExploratory âFirst in Man' Studies: Planning to Fail, or to WIN?' for free.
The presentation includes:
– Reasons for development failures
– Guidance on non clinical safety studies and exploratory CTA requirements
– Tactical and strategic applications in early clinical trials
– 2011 survey results from the International consortium for innovation & quality in pharmaceutical development
If you are interested in what Lewis had to say, you might be interested in attending Exploratory Clinical Development World Europe 2013. View the programme here.