Guidelines overview

Below are references to the Guidelines used to create the corresponding tables in the trimming manuscripts.

EMEA
Note for Guidance on Carcinogenic Potential
CPMP/SWP/2877/00
London, 25 July 2002
European Agency for the Evaluation of Medicinal Products
Evaluation of Medicines for Human Use
Committee for Proprietary Medicinal Products (CPMP)
http://www.emea.europa.eu/pdfs/human/swp/287700en.pdf

FDA
Redbook 2000
Toxicological Principles for the Safety Assessment of Food Ingredients
November 2003
IV.B.1. General Guidelines for Designing and Conducting Toxicity Studies
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments
/FoodIngredientsandPackaging/Redbook/ucm078315.htm


MHW
Japanese Ministry of Health and Welfare (1997). Pharmaceuticals and Medical Safety Bureau. In: Guidelines for Toxicity Studies and Drugs. Yakuji Nippo, Tokyo, pp 147–175

EPA
Health Effects Test Guidelines
OPPTS 870.4100, Chronic Toxicity
August 1998
United States Environmental Protection Agency
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines
/Series/870-4100.pdf


Health Effects Test Guidelines
OPPTS 870.4200, Carcinogenicity
August 1998
United States Environmental Protection Agency
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines
/Series/870-4200.pdf


Health Effects Test Guidelines
OPPTS 870.4300, Combined Chronic Toxicity/Carcinogenicity
August 1998
United States Environmental Protection Agency
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines
/Series/870-4300.pdf



NTP
Testing Information
Descriptions of NTP Study Types
2-Year Study Protocol
October 2001
U.S. National Toxicology Program
http://ntp.niehs.nih.gov/?objectid=36305D16-F1F6-975E-79776DAD38EC101E


OECD
OECD. 1981. Test Guideline 451. Carcinogenicity Studies. In: OECD Guideline for the Testing of Chemicals. Organization for Economic Cooperation & Development, Paris

OECD. 1981. Test Guideline 452. Chronic Toxicity Studies. In: OECD Guideline for the Testing of Chemicals. Organization for Economic Cooperation & Development, Paris

OECD. 1981. Test Guideline 453. Combined Chronic Toxicity / Carcinogenicity Studies. In: OECD Guideline for the Testing of Chemicals. Organization for Economic Cooperation & Development, Paris


STP
Bregman CL, Adler RR, Morton DG, Regan KS, Yano BL; Society of Toxicologic Pathology (2003) Recommended tissue list for histopathologic examination in repeat-dose toxicity and carcinogenicity studies: a proposal of the Society of Toxicologic Pathology (STP). Toxicol Pathol 31: 252–253.
PubMed abstract

see also the comment:
Jacobs A, El Hage J, Hastings K, Jacobson-Kram D, Leighton J, Morse D (2003) Recommended tissue list for histopathologic examination. Toxicol Pathol 31: 571


Further references
Leblanc B (2000) Pathology and tissue sampling protocols for rodent carcinogenicity studies: time for revision. Toxicol Pathol 28: 628–633
Ekman L (1998) The international harmonisation of guidelines in the future: a viewpoint from the industry. Toxicol Lett 102-103: 551–555