Introduction

A unique feature of pre-clinical toxicology studies is the fact that positive and negative results are of equal importance and this is quite different from the work of pharmacologists. Also, an important aspect of toxicology is the search for models that are predictive of adverse effects in humans exposed to chemicals or drugs. The study of laboratory animals is the subject of intense debate in some countries. However, there is currently no adequate alternative to identify the potential toxic effects of new drugs, the target organs of these effects and the relationship to the dose of drug. Toxicology studies are driven by government requirements and historical knowledge and an assumption that toxicity in animals is predictive of human toxicity, that the use of large doses increases the predictability and that there is some relationship between the toxic dose in animals and in humans.

It follows that any failure of the correlation between animal and human toxicity may result in an unnecessary use of animals or the unnecessary limitation or restriction in the use of a valuable drug. Thus, it is necessary to try continuously to relate the predictability of animal studies to the toxicity of drugs in humans.

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