Yu-Ting Weng
Division of Biometrics VI, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration
Caroline Strasinger
Division of New Drug Products II, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration
Meiyu Shen
Division of Biometrics VI, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration
181 – Contributed Poster Presentations: Government Statistics Section
Statistical Considerations of Adhesion Data Analysis in NDA
Yu-Ting Weng
Division of Biometrics VI, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration
Caroline Strasinger
Division of New Drug Products II, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration
Meiyu Shen
Division of Biometrics VI, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration
The Draft Guidance for Industry: Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs was issued by FDA in 2016. In the guidance, the primary endpoint is the mean adhesion score based on a 5-point numerical scaled score that corresponds to a specified range of adhered surface area of a transdermal or topical system. For the primary endpoint analysis, the non-inferiority test is used to demonstrate adequate adhesion performance of the test product compared to the reference product. However, currently no guidance is available for evaluating the adhesion performance of new drugs in New Drug Applications (NDAs) which generally do not have a reference product. Thus, in this paper for the primary endpoint, we compare the use of an ordinal-scaled score and a continuous scaled percent in an adhesion evaluation. For the primary endpoint analysis, a test-product-only approach based on the superiority test is explored to evaluate the adhesion performance of a transdermal or topical system without a reference product (e.g. new drugs of an NDA) and how to determine a margin is provided for the discussion.