chapter  2
20 Pages

Experimental Design Principles for Animal Studies in Pharmaceutical Development

WithWalter W. Piegorsch, A. John Bailer

Whether conducting a laboratory experiment, an observational study, or some other kind of pharmacological study, the scientist must recognize and accord proper consideration to issues of study design. Design is a critical step in the formulation of any pharmacological investigation, and many modern texts are available that describe in detail important forms, structures, and facets of proper experiment design. Our goal is not to replicate these readily available details; rather, we will introduce basic design terminology and discuss briefly some of the fundamental aspects of experiment design that arise in pharmacological studies. For a good introduction to experiment design, we refer the reader to Moore and McCabe (1). For technical discussions on design issues, see Hinkelmann and Kempthorne (2), Kuehl (3), or the classic text by Cochran and Cox (4). Articles targeted to pharmacological study design include Al-Banna et al. (5), Powers (6), or Ette et al. (7).