Hepatocellular Foci–-A Regulator's Gordian
| Autor: | Timothy P. O'Neill, Ronald W. Moch |
|---|---|
| Rok vydání: | 1989 |
| Předmět: |
Pathology
medicine.medical_specialty Legislation Medical Carcinogenicity Tests 040301 veterinary sciences Regulator Toxicology 030226 pharmacology & pharmacy Pathology and Forensic Medicine 0403 veterinary science Food and drug administration Lesion 03 medical and health sciences Liver Neoplasms Experimental 0302 clinical medicine Animals Medicine Molecular Biology United States Food and Drug Administration business.industry Incidence (epidemiology) 04 agricultural and veterinary sciences Cell Biology United States Liver Biological significance Regulatory agency Historical control medicine.symptom business Clear cell |
| Zdroj: | Toxicologic Pathology. 17:724-728 |
| ISSN: | 1533-1601 0192-6233 |
| DOI: | 10.1177/0192623389017004118 |
| Popis: | Recently, the Food and Drug Administration has received several petitions which raise the question of the significance of an increased number of treated rats with foci of hepatocellular alteration. Study pathologists are responsible for defining the diagnostic criteria used in any study to diagnose proliferative changes in the liver. Similarly, study pathologists, based on their observations of the overall liver findings, are responsible for assessing the biological significance of any lesion observed and including their appraisal in the written pathology narrative which should accompany any petition sent to a regulatory agency. Current scientific knowledge regarding the incidence of animals with foci of cellular alteration suggests that the historical control incidence of animals with this change is somewhat less than is currently being observed. While some foci of cellular alteration may progress to neoplastic lesions, it is not possible to unequivocally predict whether carcinogenic activity may be demonstrated, based only on the incidence of animals with foci of cellular alteration. The Food and Drug Administration, for the foreseeable future, will continue to examine the incidence of animals with selected proliferative liver lesions, including foci of cellular alteration, on a case by case basis. |
| Databáze: | OpenAIRE |
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