Drug development is a complicated, often convoluted process. The ability to predict drug toxicity in humans from nonclinical data remains a major challenge. Since you can’t “erase” an adverse event, optimization of preclinical dose selection is essential. This presentation outlines the process for dealing with adverse preclinical / nonclinical events in order to 1) optimize the chances of successful drug development, or 2) to create a scientific basis for early termination of drug development. Conclusion: Experience counts! There is no single answer for all problems. Use of sound scientific and business judgement generally yields the best outcome.
Drug Safety, TigerU