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I do not know about any FDA regulations or guidelines for analysis of placebo
samples. We conduct many Phase I studies for phramaceutical and biotech
companies. Many protocols clearly indicate that the blind will be broken for
the purpose of the analytical laboratory and only subjects on active drug
will be analyzed.
Placebo controlled study designs are important for the purpose of safety,
efficacy. If a protocol is measuring some pharmacodynamic parameter or
surrogate end point then one will collect the information on Placebo
subjects. We are currently involved in a protocol which requires platelet
aggregation studies with ADP, TRAP and Arachidonic Acid and the lab is
measuring the platelet aggregation on all subjects. However the analytical
lab will measure drug concentrations on only the subjects who received active
I have not seen too many Open Label studies with Placebo control as suggested
by Parsad in his E-mail. I donot know the significance of placebo in an open
label study. Samples from Placebo subjects may be useful to understand the
baseline noise of an analytical procedure.
Clinical Research Services, Inc.
8838 Indian River Run
Boynton Beach, FL 33437
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