DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS * ) Guideline Title Dose Selection for Carcinogenicity Studies of Pharmaceuticals

@inproceedings{1998DOSESF,
  title={DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS * ) Guideline Title Dose Selection for Carcinogenicity Studies of Pharmaceuticals},
  author={},
  year={1998}
}
  • Published 1998
Additional Notes This note for guidance concerns the application of Part 3, section II. E of the Annex to Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product. It details requirements for high dose selection and establishes a rational basis for carcinogenicity studies of pharmaceuticals. This text… CONTINUE READING