Drug Discovery Stages

 

Discovery  ( 2-10 years)
            
Pre-clinical Testing
             Laboratory and animail testing
Phase 1
             20-80 healthy volunteers used to determine safety and dosage
Phase 2
            100-300 patient volunteers used to look for efficacy(POC) and side effects
Phase 3
             3000-5000 patitent volunteers used to monitor adverse reactions to long-term use
FDA Review/Approval
             
Additional Post-marketing Testing


Source: based on data from Center for the Study of Drug Development, Tufts University, 1995