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Re: govorchin post# 10987

Sunday, 11/11/2012 4:56:04 PM

Sunday, November 11, 2012 4:56:04 PM

Post# of 403448
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Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 7 hours ] For biomarker analysis, p21 expression, assayed by qPCR, in peripheral blood lymphocytes after Kevetrin administration.

Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 24 hours ] For biomarker analysis, p21 expression, assayed by qPCR, in peripheral blood lymphocytes after Kevetrin administration.


http://clinicaltrials.gov/ct2/show/NCT01664000?term=Kevetrin&rank=1

I think there is a misinterpretation of this. I take the statement to mean the sample for "biomarker p21 in peripheral blood lymphocytes" is taken at intervals of time zero (baseline), 7 hours and then 24 hours following the administration of each dose. If that isn't the case, then the statement makes no sense since not taking the reading would mean missing p21 changes in the successive doses. A drug's action is often both delayed and cumulative. The same dose that registered no change might trigger a change in successive doses. Therefore, IMO, it only makes sense if this part of the protocol is administered for each dose for every cohort.

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