5 Steps To Planning And Executing IND-Enabling Nonclinical Studies

Nonclinical studies play a pivotal role in the investigational new drug (IND) application process, as they provide crucial evidence regarding the safety and pharmacological activity of a compound. These studies are essential for advancing drugs into first-in-human (FIH) clinical trials, making the generation of high-quality data imperative.

To facilitate this process and ensure scientifically robust and compliant IND-enabling nonclinical studies, authors have prepared a checklist comprising five essential steps.

By meticulously planning and executing these steps, development programs can confidently move forward, equipped with the necessary data to support the safe and effective progression of new drugs.