IND stands for Investigational New Drug and is submitted at what point?

• A. At the end of preclinical trials
• B. After Phase 1 completion
• C. After Phase 3 completion
• D. After marketing approval

Answer: (A)

Starting human clinical trials requires an Investigational New Drug submission. This is filed after the animal and lab (preclinical) studies have shown enough safety signals and pharmacology data to justify testing in people, but before any volunteers are given the drug. The IND includes nonclinical data, chemistry, manufacturing controls, and the plan for the first-in-human studies, so regulators can assess risk and protect participants. Once the FDA reviews and allows the plan to proceed (often with a 30-day window or with stated conditions), the sponsor can begin Phase 1. Submitting after Phase 1, after Phase 3, or after marketing approval would be out of sequence for initiating human testing. So the IND is submitted at the end of preclinical work, before starting human trials.