5 Steps to Planning and Executing IND-Enabling Nonclinical Studies
Nonclinical studies demonstrating the safety and pharmacological activity of a compound are critical components of an investigational new drug (IND) application. Data gathered from IND-enabling tests is necessary for transitioning drugs into first-in-human (FIH) clinical trials, so generating high-quality data is essential.
In this checklist, we outline five steps for planning and executing scientifically rigorous, compliant IND-enabling nonclinical studies to help move development programs forward.