Which Studies Are Required As Part Of An IND Program?

IND-enabling studies are the foundation of the drug development process, helping researchers predict safety concerns and estimate safe and efficacious starting doses for clinical trials. In most cases, the key studies required for an IND application include pharmacology, pharmacokinetics, and toxicology assessments. However, determining the appropriate studies to conduct varies depending on what the clinical indication is. It is crucial to consider all relevant guidance for your therapeutic product while conducting studies.

In this IND-enabling studies FAQ video series, learn as an expert discusses key considerations, scientific planning, and regulatory expectations so you can achieve your development timelines and milestones of your IND program.