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© 1986 Oxford University Press

other

The Necessary Minimal Duration of Final Long-Term Toxicologic Tests of Drugs1

GEORGE L. FREDERICK

Bureau of Human Prescription Drugs, Drugs Directorate. Health Protection Branch, Health and Welfare Canada Ottawa KIA 1B8, Canada

The Necessary Minimal Duration of Final Long-Term Toxicologic Tests of Drugs. FREDERICK, G. L. (1986). Fundam. Appl. Toxicol. 6, 385–394. The optimal, and thus mandatory duration of final, long-term toxicologic tests of drugs in animals prior to marketing for use in human beings remains controversial. Some regulatory authorities contend that exposure for 6 or 12 months is adequate. However, the Bureau of Human Prescription Drugs of the Health Protection Branch of Health and Welfare Canada has evaluated a number of confidential reports from manufacturers in which significant, non-neoplastic, pathologic changes occurred only after exposure of animals for more than 1 year. Fifteen examples from these files and the literature are described. These studies support the current Canadian guidelines' requirement for the duration of final long-term toxicologic tests of drugs to be at least 18 months.


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