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Drug Development Takes Longer Than It Did in the Past

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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Drug Development Takes Longer Than It Did in the Past

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  1. Post-MarketingSurveillance 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 1,000–5,000 0.5 – 2 YEARS INDEFINITE 3 – 6 YEARS 6 – 7 YEARS Drug 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.

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