Experimental design is a fundamental component of nearly all phases of drug development. These phases include studies dealing with carcinogenicity and reproductive toxicology in animals, clinical pharmacology, pharmacokinetics, and bioavailability, as well as those concerning efficacy and safety for human beings in Phases I–III and beyond. For all of these areas, statistical methodology can play an important role through its capabilities for the management of sources of variation. Many of the ways in which effective statistical involvement strengthens experimental designs are presented in the papers in this volume. Unifying concepts and issues for those papers are considered in this paper.
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