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

                               

 

FDA Issues Advice to Make Earliest Stages Of Clinical Drug Development More Efficient

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