Preclinical toxicology protocols of the laboratory of toxicology

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The qualitative or quantitative extrapolation of preclinical data to man and the accuracy of predicting toxicologic effects in the clinic depend in part on the degree of correlation between the responses of the laboratory species and the responses of man. Although preclinical toxicologic studies conducted in several species have served well to reveal the specific test parameters that act as indicators of toxicity in man, it is to be expected that unique or unusual toxic effects may remain undetected because of limitations of observations or inherent species differences. Once a toxic effect in an organ system is observed during an animal study, it should be viewed with a realistic understanding of the following limitations of animal toxicologic data: 1) The toxic effect may develop in man in an organ system predicted to be susceptible from the animal data, but may be expressed in a different specific clinical, morphologic, or chemical parameter. 2) The adverse reaction may appear in man at a greater or lesser dose level. 3) The toxic effect may follow a different order of appearance in relation to the total spectrum of qualitative toxic effects inherent in any compound. 4) The toxic effect may not develop in man. In this study the relevant methods and protocols are treated.

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National Cancer Institute Monograph

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