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Science of Medicine
Science of Medicine
Drug Development Process
Introduction
Basic Research
Clinical Research
How much money is needed
Drug Standards
Drug Manufacturing Process
Regulatory control of drugs
 
Science of Medicine
Clinical Research
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Clinical Research
   

Phase 1

 

Involves approximately 20-100 healthy volunteers to take a drug for about 1 month.

PURPOSE:
To obtain information about drug absorption and metabolism, effects on organs and tissues, and side effects for different dosage.

Phase 1
   
   

Phase 2

 

Involves several hundred health-impaired patients.:

PURPOSE:
To find out the effectiveness of the drug in treating disease and short-term side effects in health-impaired patients

Phase 2
   
   

Phase 3

 

Involves hundreds or thousands of health-impaired patients; involves treatment and control arms.

PURPOSE:
To seek the benefit/risk relationship of the drug, less common and long term side effects and abeling information.
Phase 3
   
   

Phase 4

 

Involves large numbers of health-impaired patients; usually are performed after drug approval and related to the approved indication.

PURPOSE:
To support the use of the approved indication.
Phase 4
   
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