International harmonisation of clinical pathology testing for non-clinical toxicity and safety studies

Abstract

International harmonisation of safety testing is currently of interest to industries and government agencies involved in the development and regulation of new drugs, chemicals, food products, and biological devices in global markets. A special meeting of an international working group representing ten professional scientific organisations involved primarily with clinical pathology testing in non-clinical toxicity and safety studies was held on conjunction with the 1993 European Comparative Clinical Pathology meeting in Nottingham, England. Delegates representing professional scientific organisations from the United States, United Kingdom, Japan, Germany, France, Italy, Israel, Canada, Sweden, and The Netherland have agreed to use the published testing recommendations of the American Association of Clinical Chemistry's Division of Animal Clinical Chemistry and the American Society of Veterinary Clinical Pathology as a starting point for scientific discussion and the development of internationally harmonised testing recommendations. Approximately 80 written revision proposals were reviewed and discussed. Technical issues that generated significant discussion included blood sampling protocols, urinalysis testing, and statistical analysis of clinical pathology data. A voting procedure was defined for resolution of technical issues. Final recommendations for international harmonisation of clinical pathology testing in non-clinical toxicity and safety studies are anticipated by the end of 1993.