It can take 10 to 15 years for scientists to begin the journey of understanding a disease, to creating a drug that fights it.
- IND Application: File Investigational New Drug application with the FDA before clinical testing.
- Phase 1Clinical Trial: Perform human testing in a small group of healthy volunteers to determine if the drug is safe for people. (20-100 people)
- Phase 2 Clinical Trial: Test in a small group of patients with a disease to evaluate drug effectiveness. (100-500 patients)
- Phase 3 Clinical Trial: Test in a larger group of patients to determine safety, efficacy and risk/benefit (1,000-5,000 patients)
- NDA: Submit New Drug Application to the FDA.
- Manufacture the drug on a small or large scale
- Phase 4 Trial: Pharma companies continue to monitor the drug and submit reports to the FDA re: any adverse effects.