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I have a elementary PK-PD question. We conducted two clinical studies, both
the studies are almost identical in study design with the only difference is
in one study we collected elaborate PK data and in the other study we
collected elaborate PD data alone. My dilemma is that can we combine these
two studies and perform a PK-PD relationship analysis and how valid such an
established PK-PD relationship from scientific and regulatory standpoint.
Thanks in advance for the input.
Prasad NV Tata, M. Pharm, Ph.D.
P.O. Box: 5840
675 McDonnell Blvd.
St. Louis, MO 63043
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