5,000 to 10,000 Compounds Yield 1 New Drug to Market |
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
