International Harmonization of Toxicologic Pathology Nomenclature

Author:

Mann Peter C.1,Vahle John2,Keenan Charlotte M.3,Baker Julia F.4,Bradley Alys E.5,Goodman Dawn G.6,Harada Takanori7,Herbert Ronald8,Kaufmann Wolfgang9,Kellner Rupert10,Nolte Thomas11,Rittinghausen Susanne10,Tanaka Takuji12

Affiliation:

1. EPL Northwest, Seattle, Washington, USA

2. Eli Lilly & Company, Indianapolis, Indiana, USA

3. C. M. Keenan ToxPath Consulting, Doylestown, Pennsylvania, USA

4. Charles River Pathology Associates, Frederick, Maryland, USA

5. Charles River Laboratories, Tranent, Scotland, UK

6. Private Consultant, Potomac, Maryland, USA

7. The Institute of Environmental Toxicology, Ibaraki, Japan

8. NIEHS, Research Triangle Park, NC, USA

9. Merck Serono R&D, Darmstadt, Germany

10. Fraunhofer ITEM, Hannover, Germany

11. Boehringer Ingelheim Pharma, Biberach an der Riss, Germany

12. Kanazawa Medical University, Ishikawa, Japan

Abstract

The International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice is a global project that is publishing criteria for both proliferative and nonproliferative changes in laboratory animals. This paper presents a set of general suggestions for terminology across systems. These suggestions include the use of diagnostic versus descriptive terms, modifiers, combination terms, and grading systems; and the use of thresholds, synonyms, and terminology for some processes that are common to several organ systems. The purpose of this paper is to help the reader understand some of the basic principles underlying the International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice process.

Publisher

SAGE Publications

Subject

Cell Biology,Toxicology,Molecular Biology,Pathology and Forensic Medicine

Reference15 articles.

1. Best Practices Guideline: Toxicologic Histopathology

2. Review of Pathology Data for Regulatory Purposes

3. Use and Misuse of Statistics in the Design and Interpretation of Studies

4. Greaves P. (2007). Histopathology of Preclinical Toxicity Studies: Interpretation and Relevance in Drug Safety Evaluation, 3rd ed. p. 7. Elsiever, Amsterdam, The Netherlands.

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