Post-Marketing Surveillance. Drug Discovery. Preclinical. Clinical Trials. FDA Review. Scale-Up to Mfg. ~ 5,000 – 10,000. 250. 5. COMPOUNDS. ONE FDA-APPROVED DRUG. PRE-DISCOVERY. PHASE 3. PHASE 1. PHASE 2. NDA SUBMITTED. IND SUBMITTED. NUMBER OF VOLUNTEERS. 20–100. 100–500.
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Scale-Up to Mfg.
~ 5,000 – 10,000
ONE FDA-APPROVED DRUG
NUMBER OF VOLUNTEERS
0.5 – 2 YEARS
3 – 6 YEARS
6 – 7 YEARSDrug Development Takes Longer Than It Did in the Past
Developing a new medicine takes an average of 10–15 years; the Congressional Budget Office reports that “relatively few drugs survive the clinical trial process”
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006.