Oncogenicity studies regulatory requirements

Is all this testing necessary Most toxicologists agree that if one considers the list of studies required for regulatory approval, there is a lot of redundancy. As mentioned in the introduction, the utility of repeat-dose studies of over one month should be questioned. Statistically, oncogenicity studies are very insensitive, and species and strains used should be chosen with care, as suggested by Scales and Andrews.It is hoped that the ICH... 

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