Background & Problem
A Sponsor came to Nuventra requesting a noncompartmental analysis (NCA) and clinical study report sections for a human AME study. Normally, these analyses are fairly straightforward, however this study was unique in that their radiolabeled drug stayed in the subject’s system longer than expected. Consequently, there were follow up visits once subjects were released from the clinic in order to continue sample collection during follow up visits and at home.
Nuventra takes pride in our ability to maximize the available data to reach scientifically defensible conclusions. Since we were less confident in the data collected outside the clinic, we used reasonable and conservative modeling approaches to simulate the amount excreted outside the clinic. In doing so, we not only maximized the available clinical data, but also broadened the Sponsor’s understanding of their compound.
The Sponsor told us our “report does a very, very good job of ‘making a silk purse out of a sow’s ear!’” Their clinical development program is currently in Phase 2.