In Vitro Methods in Regulatory Toxicology
So-called “in vitro” experimentation to be used replacing experiments with whole animals has often been a matter rather of emotion than of data. This is no surprise, and the data thus missing cannot be presented here. In the meantime, however, a whole lot of data has been generated, investigating in detail many aspects of experiments involving biological matter at a level below that of the whole, intact organism. One possibility was the establishment of precise dose- response-relationship comparisons among and between large families of chemical substances. For such comparisons a variety of experimental endpoints is available, often involving acute cytotoxicity. Without further knowledge about the substances to be investigated and compared, e.g. about their physico-chemi- cal attributes, interpretation of such data and comparisons becomes difficult (because of comparing e.g. different lipophilicity rather than different toxicity); this does not contribute to meaningful, risk-benefit assessment and decision as is needed for medicines and other consumer products. Such data, therefore, have become of minor interest to us and will not be presented here.
KeywordsAnimal Protection Clinical Safety Reproductive Toxicity Biological Medicine Pharmaceutical Quality
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