Zdrowie i gospodarka · 04/12/1997

FDA Publishes Guidance on Limit Dose for Carcinogenicity Studies of Pharmaceuticals

The FDA is publishing a guidance on the use of a limit dose for high dose selection in long-term carcinogenicity studies of non-genotoxic pharmaceuticals, prepared under the International Conference on Harmonisation, an addendum to an earlier ICH guidance on dose selection criteria.