Service Description

The objective of this study was to determine the potential toxicity of an androgen receptor antagonist, when given orally by capsule for a minimum of 13 weeks to female dogs and to evaluate the potential reversibility of any findings. In addition, the toxicokinetic characteristics of the antagonist and its major metabolite will be determined. Assessment will be ascertained through clinical observations, ophthalmic exams, electrocardiolagy, clinical pathology, bioanalysis, toxickinetic evaluation, and histopathogy.

What Went Well

Data was collected and documented correctly. Interpretation was expertly performed. Data was provided in a timely manner.

What Could Be Improved

Additional costs due to protocol amendments were not clearly identified and more than anticipated. More detailed discussions of the study design would have increased awareness and understanding.

Lessons Learned from the Experience

The CRO offered multiple site locations. Flexibility with site location and animal availability enabled timelines to be met. Offered expertise and additional capabilities across locations. Able to work with site close to study monitor and coordinate schedules.