11.4. Regression Modeling
In this section we will introduce statistical methods for addressing the second objective of dose-ranging studies, namely, characterization of the dose-response curve. While in the previous section we were concerned with hypothesis testing, this section will focus on modeling dose-response functions and estimation of their parameters. We will consider approaches based on linear and sigmoid (or Emax) models.
It is important to note that the modeling approaches discussed below can be used to study effects of either actual dose or pharmacokinetic exposure parameters (e.g., area under the time-plasma concentration curve or maximum plasma concentration) on the response variable of interest. When the drug's distribution follows ...
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