Abstract
This paper provides a brief overview and also critiques some of the issues related to the concepts of superiority, noninferiority, equivalence, and bioequivalence as they are encountered in clinical drug trials. These concepts and their relationships to each other are discussed here in the context of International Conference on Harmonization (ICH) documents E-9 and E-10. Most of the well-known and not so well-known properties of those concepts are discussed under the unified framework of standard Neyman-Pearson theory. Sample size adjustments for dropouts differ for intent-to-treat analysis and per protocol analysis. These differences are discussed in the context of noninferiority and superiority hypotheses.
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