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.
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