Preclinical development candidate

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Reference no: EM134006564

Question

The results from the 4-week GLP toxicology study in the rat and dog for your preclinical development candidate have just become available. The results show that your compound increased liver function tests significantly in the rat and the dog at the high dose. No adverse effects were observed at the low and middle doses.

(Note: the dose range-finding studies that were completed prior to the 4-week GLP toxicology study clearly defined the maximum tolerated doses in both the rat and dog). Based on these results, would you initiate the 3-month GLP toxicology study? Why?

Reference no: EM134006564

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