ICH E4 Dose-Response Studies Guidelines

E4 Dose-Response Studies

E4 Dose-Response Information to Support Drug Registration

The ICH Harmonised Guideline was finalised under Step 4 in March 1994. This document gives recommendations on the design and conduct of studies to assess the relationships among dose, drug-concentration in blood, and clinical response throughout the clinical development of a new drug.

Date of Step 4: 10 March 1994

Status: Step 5

Guidelines (Click the links below for complete guidelines)

E4 Guidelines

*These Guidelines Belongs to ICH website.

ICH E4 Dose-Response Studies Guidelines: