ICH E10 / Temple & Ellenberg 2000

Assay sensitivity in controlled trials. ICH (2000) E10 guideline; Temple, R., and Ellenberg, S. S. (2000). Annals of Internal Medicine 133(6), 455–463.

Relationship to this project — Assay sensitivity

A design pinned at floor or ceiling cannot support equivalence or no-effect conclusions. Basis for the project's two-sided interiority gates and the refusal to interpret ceiling cells as slope evidence.