Abstract

A Case Study of Clinical Endpoint Bioequivalence Study with Missing Data and Non-compliance Data

Missing data and non-compliance data questions are especially important in evaluating locally acting generic drugs because primary equivalence analyses in clinical endpoint bioequivalence (BE) studies are based on the per-protocol (PP) population (generally, completers and compliers). However, no case studies have been reported to address the status of missing data and non-compliance in clinical endpoint BE studies. A case study using a clinical endpoint study for topical drugs for treatment of acne vulgaris was used to illustrate the extent and pattern of drop out and non-compliance reported in the Sun et al. meta-analysis results, and whether drop out and non-compliance are random or not random, independent or correlated with each other, balanced or not balanced between the generic (TEST) and the innovator drug, i.e., the reference listed drug (RLD).


Author(s):

Sun W



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