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Updated: Dec 29, 2025

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
The potential of the estimands framework for clinical pharmacology trials: Some discussion points
Arne Ring1,2, Martin J Wolfsegger3
1University of the Free State, Bloemfontein, South Africa.
Abstract:
The recently finalised and published guideline ICH E9 (R1) introduced a new framework for the statistical analysis of clinical trials, namely that of "estimands". While the framework was originally developed for the analysis of late-phase trials, it could also provide a rigorous basis for the analysis of clinical pharmacology trials. We illustrate potential applications on two examples: a multiple dose pharmacology trial and the interpretation of confirmatory bioequivalence (BE) trials according to the current FDA and EMA BE guidelines.
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