Investigative Methods in Clinical Toxicology

¹ Department of Clinical Pharmacology, Hoffmann-LaRoche Inc., Nutley, N. J.
² Hoffmann-LaRoche Inc.

The standard preclinical animal toxicologic studies currently employed are the LD₅₀ determination in rats, pyramiding single-dose studies in dogs, and the administration of the test drug for 13 weeks in rats and 13 weeks in dogs. Chronic studies last a year or more in rats and at least six months in dogs, with a third species frequently employed as well. When the results of such studies are correlated with toxicologic experience in humans, it appears the animal experiments are successful only in eliminating highly toxic drugs from human trial and in identifying a few of the specific types of toxic reactions described. Most forms of adverse drug effects are not as yet predictable. clinical investigations must there fore seek to identify side effects as vigorously and methodically as they seek to identify efficacy. Such a search must take into account the chemical nature of the new drugs, the information provided by the pharmacologic and toxicologic animal studies, and the stage of the clinical trial.

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