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Valuable But Vulnerable: Limitless Possibilities, Growing Challenges

Valuable But Vulnerable: Limitless Possibilities, Growing Challenges. 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.

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Valuable But Vulnerable: Limitless Possibilities, Growing Challenges

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  1. Valuable But Vulnerable:Limitless Possibilities, Growing Challenges 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 Developing a new medicine is lengthy, risky, and costly. New drug development takes an average of 10–15 years, and costs approx. US $1.3 billion. Sources: Drug Discovery and Development: Understanding the R&D Process,www.innovation.org 1

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