CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products

FDA CDER Impact Story: Harnessing Statistical Power to Assess New Transdermal Delivery Systems (TDS)”

To maintain high statistical power in adhesion studies of generic TDS products, CDER scientists have refined threshold measures of noninferiority. Instead of evaluating similarity of adhesion between test and reference scores as the ratio-of-means adhesion scores, for example, CDER statisticians turned to a comparison based the difference-of-mean adhesion scores.