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Old 08-08-2011
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Default clinical trials

For a new medication, during which phase of clinical trials is efficacy first determined?
A. Phase IV
B. Phase III
C. Phase I
D. Phase II
E. Phase 0
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Old 08-08-2011
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Phase III ?
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Old 08-08-2011
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I go with Phase 2*******
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Last edited by patelMD; 08-08-2011 at 03:42 PM.
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Old 08-08-2011
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Originally Posted by patelMD View Post
I go with Phase I
but phase I is when they give the new drug to healthy volunteers to check for side effects no? ..i think im not sure! lol
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Old 08-08-2011
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but phase I is when they give the new drug to healthy volunteers to check for side effects no? ..i think im not sure! lol
You're right, I think its Phase 2 then, because by Phase 3 the drug is used in a large group to assess treatment vs. placebo.. so I'd go with Phase 2
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Originally Posted by ricko335 View Post
For a new medication, during which phase of clinical trials is efficacy first determined?
A. Phase IV
B. Phase III
C. Phase I
D. Phase II
E. Phase 0
phase 2 where the drug is administered to check the effective dose n side effects
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The correct answer is D.
During Phase 0, a single, subtherapeutic dose is given. The goal is to obtain preliminary pharmacokinetic and pharmacodynamic data.
Phase I trials are to determine safety, pharmacokinetics, and pharmacodynamics.
Phase II trials identify/prove efficacy and adverse effects.
Phase III trials compare the treatment to the existing gold standard. This differs from Phase II in that Phase II merely seeks to show that the drug works for the proposed indication.
Phase IV consists of post-marketing surveillance
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Old 12-05-2013
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I think for me Phase II because it is the middle of the test and in this Phase, medical researchers can determine if the new drug or treatment is effective or has a side effects.
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