Clinical tests chronic toxicity studies

Effects in Adult Animals in Chronic Toxicity Studies Doses Tested in EFD Study (NOAEL or highest dose tested) Effects on Fertility, Pregnancy and Development Clinical Dose Pregnancy Category... 

Chronic exposure is needed to identify most carcinogens. The cancer bioassay is thus similar to the chronic toxicity test covered in the last chapter. The major difference is that the toxicologist and the pathologist are generally searching only for evidence of tumor formation, and certain of the clinical measurements typically associated with the chronic toxicity study may be omitted from the protocol. 

Neurotoxicity. No clinical signs of central nervous system toxicity or histological alterations of nervous system organs and tissues were observed in rats or mice in the NCI (1978) chronic oral bioassay. Tests for neurotoxicity in animals may be appropriate if there is clinical evidence of neurological dysfunction in general oral or dermal toxicity studies of I 2-diphenylhydrazine. 

It often requires 4-6 years of clinical testing to accumulate all required data. Testing in humans is begun after sufficient acute and subacute animal toxicity studies have been completed. Chronic safety testing in animals is usually done concurrently with clinical trials. In each of the three formal phases of clinical trials, volunteers or patients must be informed of the investigational status of the... 

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