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
*These Guidelines Belongs to ICH website.
