Dose-Response Information to Support Drug Registration by ICH

Primary ICH-E4 guidance hosted by the FDA: www.fda.gov/media/71279/download . PDF title page dates the guideline November 1994; FDA landing page dates its guidance listing July 1996: www.fda.gov/regulatory-information/search-fda-guidance-documents/e4-dose-response-information-support-drug-registration . Sections I.C–E distinguish concentration response, dose titration and time; Section III discusses study designs. Used for scientific design concepts, not present regulatory obligations or individual dose selection.