ICH E4 Dose response information to support drug registration - Scientific guideline
Table of contents
This document provides guidance on obtaining dose-response information. It describes the study designs for assessing dose-resposne.
Keywords: Dose-response curve, desirable effects, undesirable effects, starting dose, intersubject variability, pharmacodynamic response, pharmacokinetic difference, concentration-response data, titration design, life-threatening diseases, parallel dose-response, cross-over dose-response, placebo-controlled titration