Kw. Weingand, INTERNATIONAL HARMONIZATION OF CLINICAL PATHOLOGY TESTING FOR NONCLINICAL TOXICITY AND SAFETY STUDIES, Comparative haematology international, 3(3), 1993, pp. 164-167
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.