“The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective” advises:
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
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