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Re: rwwest post# 26340

Friday, 05/10/2019 3:56:10 AM

Friday, May 10, 2019 3:56:10 AM

Post# of 34749
rwwest, from:

http://www.virginia.edu/vpr/irb/HSR_docs/CLINICAL_TRIALS_Phases.pdf

"Phase IIb: Well controlled trials to evaluate efficacy ( and safety) in patients with the disease or condition to be treated, diagnosed, or prevented. These clinical trials usually represent the most rigorous demonstration of a medicine's efficacy.
Sometimes referred to as pivotal trials.


Phase IIIa: Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug Application (NDA) or other dossier. . . "
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