11.1. Introduction
Dose-ranging studies are conducted at early stages of drug development (both pre-clinical and clinical stages) to evaluate safety and efficacy of experimental drugs. A large number of publications deal with the analysis of dose-ranging studies designed to test several doses (or dose regimens) of an experimental drug versus a control. This area of research is commonly referred to as dose-response analysis covers the relationship between dose and clinical response.
There are several distinct research topics within dose-response analysis (Ruberg, 1995a):
Assessment of the dose-related trend in the response variable.
Estimation of the shape of the dose-response function.
Determination of optimal doses (including identification of ...
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