Service Description

The CRO conducted an early stage toxicity study designed to determine dose ranges for a future formal GLP repeat dose toxicity study. This study consisted of 2 phases. There was a single escalating dose phase. It was followed by a 14-day repeat dose phase.

What Went Well

This kind of study requires constant careful attention as changes in dose level occur based on clinical signs. The study director was very attentive and came in to observe the animals during the weekend and off hours. Consequently, maximal value was gotten from the study and the animals were well cared for.

What Could Be Improved

The study was well run. Changing dose levels required IAUCUC committee meeting and agreement which was time consuming and made making changes a little lengthy and cumbersome. But I also understand the rationale.

Lessons Learned from the Experience

I learned that study directors tend to work harder on these smaller early stage nonGLP studies than they do on the larger GLP studies. I would look for an attentive study director for these kind of studies. I don't know that there was much thinking outside of the box, other than the possible dose elevations were discussed ahead of time so that IAUCUC committee approval of potential changes would go more smoothly.