Back to Agendas
Statistical Evaluation of Therapeutic Equivalence for Locally-Acting Generic Products
Session Chair(s)
Stella C. Grosser, PhD, MS
Division Director, Office of Biostatistics, OTS, CDER
FDA, United States
Bioequivalence of generic drugs to innovator products has traditionally been evaluated using pharmacokinetic studies with endpoints such as mean area under the concentration curve and analyses such as calculating confidence intervals around the ratio of means. However, the evaluation of bioequivalence for locally-acting products is complicated by the fact that such pharmacokinetic studies do not capture the information necessary for determining equivalence. This session will outline the statistical issues involved and offer examples of innovative approaches to solving the problem. Such issues relate to the choice of the design, the formulation of the statistical hypotheses and the factors that affect the power of the statistical test.
Learning Objective : Recognize the appropriate hypotheses to be tested, including the difference between testing for efficacy and testing for equivalence; Discuss the need for an appropriate model based on the nature of the available data; Provide an overview of ways to evaluate the performance of a statistical approach in order to choose the best model and estimate the sample size necessary to achieve a certain level of accuracy.
Speaker(s)
Special Cases for the Statistical Evaluation of Bioequivalence: An Example of In Vitro Skin Permeation Test Data
Elena Rantou, PhD
FDA, United States
Lead Mathematical Statistician, OB, Office of Translational Sciences, CDER
A Meta-Analysis of Missing Data and Noncompliance Data in ANDA Clinical Endpoint Bioequivalence Studies
Wanjie Sun, PhD
FDA, United States
Senior Math Statistician
Design and Data Analysis Challenges for Establishing Therapeutic Equivalence in Clinical Endpoint Studies
Keith Gallicano, PhD
Novum Pharmaceutical Research Services, United States
Vice President, Scientific Affairs
Have an account?