In drug development, nonclinical studies are essential for establishing the safety of a new potential drug product and determining a safe starting dose for human clinical trials. The key to success lies in designing and conducting the appropriate nonclinical studies to support an IND application in the most efficient and cost-effective manner.
In this paper, we offer insight into the importance of – and requirements for – nonclinical studies and provide recommendations for putting together a nonclinical program team that optimizes the likelihood of moving candidates into clinical trials.
We’ll answer questions like:
- How can a sponsor determine the number and design of its nonclinical studies?
- What are some key considerations for finding the right partner for a nonclinical program?
- How can a sponsor mitigate potential challenges encountered during nonclinical studies?