title: [Value of the results of animal experiments for the evaluation of drugs. 2. Methodology and prediction of effects].
abstract: The efficiency of animal trials is critically examined against the background of the new EC drug regulations. The present contributions deal with the problem of predictability of qualitative events. It is established that the so-called "pharmacological properties" of substances do not exist. Further it must be taken into account that observations made on test animals are reductionistic in relation to man. The study also shows that it is difficult to predict events with reasonable certainty even within one particular animal species. The problem of extrapolation is being viewed under three different aspects: when there is no previous experience at all, when there is relevant previous experience, and when there are animal models available. In the first case, it is impossible to make any prediction at all. In the second case, only subjective suppositions are possible. As to the third case, it is an open question at the moment whether animal models do exist at all. According to the present state of science it is not possible to make objective predictions for man on the basis of animal trials. In regard to animal trials, the EC regulations stand in contrast to science and the methodology of statistics. The subjective nature of prediction will be discussed in the following contributions.
mesh_terms: D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods; D006801:Humans; D012107:Research Design; D013223:Statistics as Topic
vernacular_title: Der Wert tierexperimenteller Ergebnisse für die Beurteilung von Arzneimitteln. Folge 2: Methodik und Wirkungsvorhersage