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Steps of drug development
 
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DRUG DEVELOPMENT PROCESS: 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