Guided Notes
The Drug Development Lifecycle
From discovery to approval and beyond — preclinical work, IND, Phase 1–4 trials, NDA/BLA submissions, regulators, timelines and where data management contributes at each step.
From molecule to medicine
Slide 1 / 5Developing a new drug commonly takes 10–15 years and very large investment, and most candidates fail along the way. 1. Discovery — identify a target and candidate molecules. 2. Preclinical — lab and animal studies for safety and pharmacology. 3. IND (Investigational New Drug application) — permission from the FDA to test in humans. 4. Clinical trials — Phases 1, 2, 3. 5. NDA (drugs) or BLA (biologics) submission and regulatory review. 6. Approval and Phase 4 / post-marketing surveillance.