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EMA: Scientific guideline: Guideline on repeated dose toxicity

09.11.2010
This guideline concerns the conduct of repeated dose toxicity studies of active substances intended for human use. For certain types of substances, such as biotechnology-derived compounds, vaccines and anticancer medicinal products, specific guidance is available (see CPMP/ICH/302/95 Note for guidance on Safety studies for biotechnological products, CPMP/SWP/465/95 Note for guidance on Pre-clinical pharmacological and toxicological testing of vaccines, CPMP/SWP/997/96 Note for guidance on the Preclinical evaluation of anticancer medicinal products). The guideline should be considered also in case of herbal products.