Society of Toxicologic Pathology Position Paper: Organ Weight Recommendations for Toxicology Studies
| Autor: | Nigel Roome, Bindhu Michael, Ken Schafer, Rick Perry, Rani S. Sellers, Daniel Morton, Julie K. Johnson, Barry L. Yano |
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| Rok vydání: | 2007 |
| Předmět: |
Pituitary gland
Pathology medicine.medical_specialty 040301 veterinary sciences Context (language use) Toxicology 030226 pharmacology & pharmacy Pathology and Forensic Medicine 0403 veterinary science 03 medical and health sciences Reproductive senescence 0302 clinical medicine Prostate Toxicity Tests medicine Animals Sexual maturity Molecular Biology business.industry Body Weight Thyroid Anatomical pathology Organ Size 04 agricultural and veterinary sciences Cell Biology medicine.anatomical_structure Toxicity business |
| Zdroj: | Toxicologic Pathology. 35:751-755 |
| ISSN: | 1533-1601 0192-6233 |
| DOI: | 10.1080/01926230701595300 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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