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Reply | Forward Message #22 of 634 |
http://joinleenow.org/html/press/pdf/faq_a.pdf

If you look at page 4 on the above link, I think that this may answer
your question at least partially. I believe that the mouse studies that
they are currently conducting are part of the early Phase I Trials. The
human part of the studies won't begin until late in the Phase I Trial.

Also, here are some definitions that may be helpful:

PHASE I TRIALS: Initial studies to determine the metabolism and
pharmacologic actions of drugs in humans, the side effects associated
with increasing doses, and to gain early evidence of effectiveness; may
include healthy participants and/or patients.

PHASE II TRIALS: Controlled clinical studies conducted to evaluate the
effectiveness of the drug for a particular indication or indications in
patients with the disease or condition under study and to determine the
common short-term side effects and risks.

PHASE III TRIALS: Expanded controlled and uncontrolled trials after
preliminary evidence suggesting effectiveness of the drug has been
obtained, and are intended to gather additional information to evaluate
the overall benefit-risk relationship of the drug and provide and
adequate basis for physician labeling.

PHASE IV TRIALS: Post-marketing studies to delineate additional
information including the drug's risks, benefits, and optimal use.

Patsy

>--- In nathanfaustmantrials@yahoogroups.com, "imcimc1" <imcimc1@y...>
>wrote:
>
>
>>If they have technically begun clinical trials, what phase are they
>>in? Once the human trials start in 2007, what phase will that be
>>considered. Also, are they on this so-called "fast track" with the
>>FDA? That seems to be either a catch phrase for hope or a real push
>>with the FDA to expedite what seems to more than promising. I/m
>>
>>
>pretty
>
>
>>sure that Dr. Vinik's work at the Strelitz institute is on the "fast
>>track." Any feeback would be welcome, thanks!
>>
>>







Mon Jan 30, 2006 6:43 pm

PatsyVanHuyck
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http://joinleenow.org/html/press/pdf/faq_a.pdf If you look at page 4 on the above link, I think that this may answer your question at least partially. I...
Patsy Van Huyck
PatsyVanHuyck
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Jan 30, 2006
7:26 pm
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