Implications of recommendations from the International Conference on Harmonization (ICH) for the safety evaluation of new medicines involving animal studies for the pharmaceutical industry.

Based upon the recommendations given by the ICH outlined in this document, it is proposed that: 1. In rodents, single dose toxicity studies should be conducted using as few animals as possible. 2. Single dose toxicity studies in non-rodents will not be performed except possibly as a component of dose escalation studies. 3. Recovery animals on repeat dose studies will not be monitored for delayed toxicity. 4. Twelve month rodent studies will not be performed. 5. Twelve month non-rodent studies will be performed for chronic therapies except in the few circumstances when the ICH exclusion criteria can be met. 6. EEC protocols for reproductive toxicology studies will be followed until a new guideline is issued. 7. Consultation with regulatory authorities, especially the FDA, may be required to set the doses to be used in carcinogenicity studies.