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Recommended Tissue List for Histopathologic Examination in Repeat-Dose Toxicity and Carcinogenicity Studies: A Proposal of the Society of Toxicologic Pathology (STP)
Carla L. Bregman
Bristol-Myers Squibb Company, Syracuse, New York
Rick R. Adler
Pfizer, Inc, Ann Arbor, Michigan
Daniel G. Morton
Pharmacia Corporation, Skokie, Illinois
Karen S. Regan
Regan Path/Tox Services, Ashland, Ohio
Barry L. Yano
The Dow Chemical Company, Midland, Michigan
The Executive Committee of the Society of Toxicologic Pathology (STP) appointed an ad hoc task force to devise and recommend a standard list of tissues to be evaluated histopathologically in repeat-dose toxicity and carcinogenicity studies that are used to support the registration of new pharmaceutical products. The recommended tissue list is intended to be a minimum core list that can be used for all types of repeat-dose toxicity and carcinogenicity studies, regardless of route of administration, species or strain of mammalian laboratory animal, duration, or class of drug to be tested. The resulting recommendations of the task force, presented here, were subsequently reviewed by the STP membership and endorsed by the STP Executive Committee.
Key Words: Animals • carcinogenicity • histopathology • organs • regulations • repeat-dose • tissues • toxicity.
References
- Committee for Proprietary Medicinal Products (1999). Note for guidance on repeat dose toxicity testing; Appendix A.
- Committee for Proprietary Medicinal Products (2000). Note for guidance on carcinogenic potential; Tissue list A.
- Japanese Ministry of Health and Welfare (1989). Notification No. 24 of the Pharmaceutical Affairs Bureau. Section [2]: Repeated dose toxicity study.
- McConnell EE (1983). Pathology requirements for rodent 2-year studies. I. A review of current procedures. Toxicol Pathol 11(1): 60—64.[Abstract/Free Full Text]
- U.S. Environmental Protection Agency, OPPTS (Office of Prevention, Pesticides and Toxic Substances) ( 1998). Health effects test guidelines: Nos. 870.3100 (90-Day Oral Toxicity in Rodents), 870.3150 (90-Day Oral Toxicity in Nonrodents), 870.4100 (Chronic Toxicity), 870.4200 (Carcinogenicity), 870.4300 (Combined Chronic Toxicity/Carcinogenicity).
Toxicologic Pathology, Vol. 31, No. 2,
252-253 (2003)
DOI: 10.1080/01926230390183751
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