11.2. Design Considerations

11.2.1. Types of Dose-Ranging Studies

To define dose-ranging studies, we may consider the entire class of studies that involve multiple doses of an active compound. This broad class includes dose-escalation or dose-titration studies (i.e., the dose could go up or down for the same trial subject), parallel group studies (subjects are randomized to distinct dose groups) or cross-over studies involving sequences of various dose administrations. When considering the design of a dose-ranging study, we must first consider patient safety, especially in the early stages of drug development. Regardless of how much in vitro or animal testing has been completed, human subjects must be exposed to a new chemical entity on a gradual ...

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