Dose-Response Experimental Design and Analysis

Dose-response design is a framework for planning and analysing experiments that characterise the relationship between the amount of a stimulus — such as a drug dose or a chemical concentration — and the magnitude of a biological or physiological response. Formalised in regulatory guidance by the ICH E4 guideline (1994) and extensively developed in the statistical literature by Ritz et al. (2015), the framework covers experiment design, four-parameter and five-parameter logistic curve fitting, key benchmark estimates (ED50/EC50, NOAEL, LOAEL), and monotone trend testing via the Williams procedure.