baseline correction method using the mean of three pre-dose samples is adequate when determining bioequivalence between two levothyroxine sodium products.
I'd now like to introduce Dr. Barbara Davit who will be speaking on potassium chloride.
DR. DAVIT: Thank you. I'm Barbara Davit, and I recently became the Deputy Director for the Division of Bioequivalence in the Office of Generic Drugs.
I'll be presenting some information today about baseline correction methods for endogenous compounds for which the Division of Bioequivalence has a fair amount of experience and that's potassium chloride.
I'll be discussing the design of potassium chloride bioequivalence studies that we've been implementing, the application of baseline correction methods to bioequivalence study data, the impact of baseline correction on bioequivalence study outcome, and to accomplish this, I have two cases to present, one in which baseline correction made a difference in study outcome, the other in which it made no difference in study outcome. Finally, I'll compare two methods for baseline