PRE-CLINICAL

Apart from the standard design of experiments (DOE) and analysis optimization that we undertake, we also manage some more complex requests. These two case studies outline our solution to two such requests.

Mouse toxicology study

A client had submitted some mouse toxicology data to the FDA on 3 different formulations of a drug, but received a response indicating the analysis methodology was inadequate. The FDA was concerned that the data, when analyzed optimally, would reveal increased tumor development. Quantics were asked to review and reanalyze the data to fully satisfy the FDA.
We found that there was a significant, but shallow dose response in the development of tumors with one of the three formulations, but no evidence in the other two.
The company was able to (successfully) resubmit the data omitting the problem formulation.

Effects of animal house operator on a challenge assay

A client was concerned that their in vivo data seemed to be correlated with the animal house operator carrying out the work. The remit was to determine if there was a problem, and if so, provide suggestions to improve the assay design such that operator variability became insignificant and the assay did not depend upon availability of one individual.

Quantics

• Reviewed the entire assay to determine the key sources of variation
• Designed additional studies to test alternative operator performance (ensuring that the assay was repeated sufficiently to power the study, including appropriate randomisation / blinding to treatment groups)
• Analysed the data to devise acceptance criteria for every assay run by alternative  operators
• Delivered assay designs to ensure that variation added by other operators would still result in acceptable data