No-observed-adverse-effect level (NOAEL) in IND Programs

Toxicology studies in drug development help identify potential safety issues and target organs in humans to identify translational markers of potential toxicity in later human trials and they can provide high-quality and reliable data on which to base the safe starting dose in humans. The data from these studies, and particularly the no-observed-adverse-effect level (NOAEL) information is essential for the safe and effective development of new drugs. In this podcast, we discuss the importance of NOAEL information in safety and toxicology studies.

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