Drug development takes longer than it did in the past
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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

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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