Chapter 4
Dose-finding Methods
Srinand Nandakumar (Pfizer)
Alex Dmitrienko (Mediana)
Ilya Lipkovich (QuintilesIMS)
4.3 Dose-response assessment and dose-finding methods
4.4 Dose finding in Case study 1
4.5 Dose finding in Case study 2
The chapter introduces a family of statistical methods used in Phase II trials to study the relationship between the dose of an experimental treatment and clinical response. This includes methods aimed at testing the dose-response trend; estimating the underlying dose-response function; and identifying a dose or set of doses to be examined in the subsequent confirmatory trials. Powerful methods for detecting dose-response signals use one or more contrasts that evaluate ...
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