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Clinical Trials involve the following phases:

Testing in Humans
 
Number of Patients
Length
Purpose
Percent of Drugs Successfully Tested
Phase I
20 - 100
Several months
Mainly safety
70 percent
Phase II
Upto several hundred
Several months to 2 years
Some short-term safety, but mainly effectiveness
33 percent
Phase III
Several hundred to several thousand
1 - 4 years
Safety, effectiveness, dosage
25 - 30 percent
Phase IV Click here for revelant details


For example, of 100 drugs for which Investigational New Drug applications are submitted to FDA, about 70 percent will successfully complete Phase I and go on to Phase II; about 33 percent of the original 100 will complete Phase II and go to Phase III; and 25 to 30 of the original 100 will clear Phase III (and, on average, about 20 of the original 100 will ultimately be approved for marketing).

 

 

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