INTERNATIONAL HARMONIZATION OF CLINICAL PATHOLOGY TESTING FOR NONCLINICAL TOXICITY AND SAFETY STUDIES

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 dev ices 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 Compara tive Clinical Pathology meeting in Nottingham, England. Delegates repr esenting 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 recommen dations of the American Association of Clinical Chemistry's Division o f Animal Clinical Chemistry and the American Society of Veterinary Cli nical Pathology as a starting point for scientific discussion and the development of internationally harmonised testing recommendations. App roximately 80 written revision proposals were reviewed and discussed. Technical issues that generated significant discussion included blood sampling protocols, urinalysis testing, and statistical analysis of cl inical pathology data. A voting procedure was defined for resolution o f technical issues. Final recommendations for international harmonisat ion of clinical pathology testing in non-clinical toxicity and safety studies are anticipated by the end of 1993.