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Re: QuitinMyJob post# 733

Wednesday, 07/01/2020 7:08:46 PM

Wednesday, July 01, 2020 7:08:46 PM

Post# of 36578
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

Clinical Research Phase Studies

 

Phase 1

?

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

Purpose: Safety and dosage

 

Approximately 70% of drugs move to the next phase

 

Phase 2

?

Study Participants: Up to several hundred people with the disease/condition.

Length of Study: Several months to 2 years

Purpose: Efficacy and side effects

 

Approximately 33% of drugs move to the next phase

 

Phase 3

?

Study Participants: 300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

 

Approximately 25-30% of drugs move to the next phase

 

Phase 4

?

Study Participants: Several thousand volunteers who have the disease/condition

Purpose: Safety and efficacy