Abstract
In an attempt to improve safety assessment and standardise regulatory testing guidelines, with the view of gaining universal agreement on clinical pathology testing, an international working party was formed. The joint scientific committee for International Harmonisation of Clinical Pathology Testing (IHCPT) represented ten national scientific organisations and undertook to provide expert recommendations for clinical pathology testing of laboratory animal species used in regulatory toxicity and safety studies. This article highlights the Committee's recommendations on blood sampling procedures and the appropriate selection of tests to be included in the disciplines of blood chemistry, haematology and urinalysis.
Similar content being viewed by others
References
Alder S, Janton C, Zbinden G (1981) Preclinical safety requirements in 1980. Swiss Federal Institute of Technology and University of Zurich
EPA (1984) US Environmental Protection Agency. Pesticide assessment guidelines. National Technical Information Service, Springfield VA, USA EPA/540/9-84/014
FDA (1979) US Food and Drug Administration, Nonclinical laboratory studies: good laboratory practice regulations. Federal Register. 43: 59986–60025
FDA (1982) US Food and Drug Administration, Bureau of Foods, in Toxicological principles for the safety assessment of direct food additives and colour additives used in food. National Technical Information Service, Springfield VA, USA PB 83-170696
Malya PG, Nachbaur J, Dooley JF et al. (1988) Drug interference tests on laboratory animals during toxocity studies. J Clin Chem Clin Biochem 26:175–179
MHW (1989) Ministry of Health and Welfare in Japan, 1989, Notification 24 of the Pharmaceutical Affairs Bureau. Guidelines of Toxicity Studies of Drug
OECD (1982) Organisation of Economic Cooporation and Development. Principle of good laboratory practice, OECD Guidelines for Testing of Chemicals. C(81)30 Final Annex 2
Stonard MD (1990) Assessment of renal function and damage in animal species. J Appl Toxicol 10:267–274
Stonard MD (1992) Clinical biochemistry requirements in the Organisation for Economic Cooperation and Development Guidelines — United Kingdom Recommendations. Toxicol Pathol 20:506–508
Weingand K, Brown G, Hall R, Davies D et al. (1996) Harmonization of Clinical Pathology Testing in Toxicity and Safety Studies. Fund App Toxicol
Author information
Authors and Affiliations
Additional information
Originally presented at the Second European Comparative Clinical Pathology Conference, Dijon
Rights and permissions
About this article
Cite this article
Davies, D. Review of the International Harmonisation of Clinical Pathology testing (IHCPT) recommendations on study design and clinical pathology testing. Comp Haematol Int 5, 206–209 (1995). https://doi.org/10.1007/BF00368046
Issue Date:
DOI: https://doi.org/10.1007/BF00368046