Toxicologic Pathology

 

Advanced Search

Journal Navigation

Journal Home

Subscriptions

Archive

Contact Us

Table of Contents

Register here to gain access to SAGE's 500+ Journals Online

Click here to sign up for SAGE Journal Email Alerts today!

Sign In to gain access to subscriptions and/or personal tools.
This Article
Right arrow Free Full Text Free
Right arrow Free Full Text (Free PDF) Free
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to Saved Citations
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Request Reprints
Right arrow Add to My Marked Citations
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Sellers, R. S.
Right arrow Articles by Schafer, K.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Sellers, R. S.
Right arrow Articles by Schafer, K.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Reddit   Add to Technorati  
What's this?
Toxicologic Pathology, Vol. 35, No. 5, 751-755 (2007)
DOI: 10.1080/01926230701595300

Regulatory Forum

Society of Toxicologic Pathology Position Paper: Organ Weight Recommendations for Toxicology Studies

Rani S. Sellers1, Daniel Mortan2, Bindu Michael3, Nigel Roome4, Julie K. Johnson5, Barry L. Yano6, Rick Perry7 and Ken Schafer8

1 Albert Einstein College of Medicine, Bronx, New York 10461, USA
2 Pfizer, Inc., Groton, Connecticut 06340 USA
3 Merck Research Laboratories, West Point, Pennsylvania 19586, USA
4 Sanofi-aventis, Porcheville, France
5 Abbott Laboratories, Abbott Park, Illinois 60064, USA
6 The Dow Chemical Company, Midland, Michigan 48674, USA
7 Wyeth Research, Chazy, New York 12921, USA
8 Vet Path Services, Inc., Mason, Ohio 45040, USA

Correspondence: Address correspondence to Rani S. Sellers, Albert Einstein College of Medicine, 1300 Morris Park Ave., Bronx, NY 10461, USA; e-mail:rsellers{at}aecom.yu.edu

The evaluation of organ weights in toxicology studies is an integral component in the assessment of pharmaceuticals, chemicals, and medical devices. The Society of Toxicologic Pathology (STP) has created recommendations for weighing organs in GLP general toxicology studies lasting from 7 days to 1 year. The STP recommends that liver, heart, kidneys, brain, testes, and adrenal glands be weighed in all multidose general toxicology studies. Thyroid gland and pituitary gland weights are recommended for all species except mice. Spleen and thymus should be weighed in rodent studies and may be weighed in non-rodent studies. Weighing of reproductive organs is most valuable in sexually mature animals. Variability in age, sexual maturity, and stage of cycle in non-rodents and reproductive senescence in female rodents may complicate or limit interpretation of reproductive organ weights. The STP recommends that testes of all species be weighed in multidose general toxicology studies. Epididymides and prostate should be weighed in rat studies and may be weighed on a case-by-case basis in non-rodent and mouse studies. Weighing of other organs including female reproductive organs should be considered on a case-by-case basis. Organ weights are not recommended for any carcinogenicity studies including the alternative mouse bioassays. Regardless of the study type or organs evaluated, organ weight changes must be evaluated within the context of the compound class, mechanism of action, and the entire data set for that study.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati    What's this?