[Formal sample size calculation and its limited validity in animal studies of medical basic research].

Animal studies are highly relevant for basic medical research, although their usage is discussed controversially in public. Thus, an optimal sample size for these projects should be aimed at from a biometrical point of view. Statistical sample size calculation is usually the appropriate methodology in planning medical research projects. However, required information is often not valid or only available during the course of an animal experiment. This article critically discusses the validity of formal sample size calculation for animal studies. Within the discussion, some requirements are formulated to fundamentally regulate the process of sample size determination for animal experiments.