The American Statistical Association Biopharmaceutical Section Regulatory-Industry Statistics Workshop was originally a meeting for the FDA statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA. This year over 800 people are expected to attend this workshop on Sep. 25-27, 2017 in Marriott Wardman Park, Washington D.C.

Dr. Niazi is providing a unique thermodynamic equivalence insight into Statistical Evaluation of Generic Transdermal Delivery Systems and Tropical Patches, as one of his areas of expertise and plans to participate in several sessions relating to biosimilars. The FDA provides the following comment on the Niazi’s session: “With the passage of Generic Drug User Fee Act (GDUFA), there is an increased emphasis on research for generic drugs, especially in the field of statistical evaluation of generic transdermal delivery systems and topical patches (hereafter referred as TDS products). Office of Generic Drugs (OGD) in FDA CDER recommends two types of studies for TDS products Abbreviated New Drug Applications (ANDAs): one is bioequivalence (BE) with pharmacokinetic (PK) endpoints study, and the other one is the skin irritation, sensitization and adhesion study. 

For skin irritation, sensitization, and adhesion study, the applicant usually conducts two studies, an adhesion study and an irritation/sensitization study. To support regulatory approval, in addition to the bioequivalence of PK endpoints, the test product must adhere at least as well as the reference product, be no more irritating than the reference and be no more sensitizing than the reference. This session will discuss statistical issues, challenges and approaches in the adhesion study and irritation/sensitization study for generic TDS products.”