IND is submitted at what point in development?

• A. Submitted at the end of preclinical trials
• B. Submitted after Phase 1 to begin Phase 2
• C. Submitted after Phase 3
• D. Submitted during the first year of development

Answer: (A)

An IND is filed after preclinical work has shown enough safety and pharmacology/toxicology data to justify testing in humans. This means animal and in vitro studies have demonstrated a reasonable expectation of safety, and manufacturing information is in place so the FDA can review the proposed clinical plan. With the IND approved, first-in-human trials can proceed. Therefore, the appropriate point in development to submit is at the end of preclinical development, before any human trials begin. Submitting after Phase 1 to start Phase 2 isn’t allowed because human trials can’t start without regulatory approval, and submitting only during the first year or after Phase 3 would be too late.