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Problems in Predicting Drug Effects across Species Lines

During the course of drug development, there are many instances where extrapolation of data from animals to man is difficult because the toxicologic and metabolic responses induced by drugs may be significantly different between the laboratory species. In cases where the drug in question has a potentially major therapeutic use in man, it is suggested that the data be evaluated on the basis of a pragmatic benefit-to-risk ratio, rather than zero-toxicity. In this way, we may provide drug therapy for those patients for whom adequate treatment does not exist, as well as protect those individuals who may be exposed to some hazard from the use of medicines.