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5,000 to 10,000 Compounds Yield 1 New Drug to Market
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|
Step
|
Number of Compounds
|
Years
|
|
0
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
15
|
| Discovery – identifying and screening |
5,000—10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Preclinical Testing – in laboratory and animal studies |
250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Phase I – Clinical Testing. Safety and dosage evaluated on 20-100 healthy human volunteers |
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Phase II – Clinical Testing. Efficacy and side effects tested on 100-500 patient volunteers |
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Phase III – Clinical Testing. Effectiveness and reactions to long-term use tested on 1,000 to 5,000 patient volunteers |
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| FDA Review and Approval |
1
|
|
|
|
|
|
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FDA Issues Advice to Make Earliest Stages Of Clinical Drug Development More Efficient
