Critical Steps

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

 

Pacific BioLabs