How Sample Issues Can Cause Bioequivalence Studies To Fail

Bioequivalence studies leave little room for avoidable variability. To show that a new formulation is equivalent to a reference product, sponsors need pharmacokinetic results to fall within a strict statistical range.

In this short webinar excerpt, Dr. Richard Graham explains why biological sample issues can have such an outsized impact in that setting. When samples are lost, switched, mishandled, or otherwise rendered unusable, they can add noise to data that needs to be precise. That can be enough to put the study outcome at risk.