Food and Drug Administration Risk Assessment—Process and Toxicologic Pathology
| Autor: | Prem N. Dua, Ronald W. Moch, Fred A. Hines |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Brain hemorrhage
Pathology medicine.medical_specialty 040301 veterinary sciences Toxicology Risk Assessment 030226 pharmacology & pharmacy Pathology and Forensic Medicine 0403 veterinary science Food and drug administration 03 medical and health sciences 0302 clinical medicine Animals Humans Medicine Review process Molecular Biology Pathology Clinical United States Food and Drug Administration business.industry Investigational New Drug 04 agricultural and veterinary sciences Cell Biology Food safety United States Food Additives business Risk assessment |
| Zdroj: | Toxicologic Pathology. 25:61-67 |
| ISSN: | 1533-1601 0192-6233 |
| Popis: | A general outline of the risk assessment process at the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration based on the toxicologic evaluation of data is described. Examples of recent pathology evaluations are presented to illustrate primarily the pathology review process at the CFSAN. These examples include the review of data from rodent studies from proposed indirect food additives and data from dog studies submitted in support of an investigational new drug, a short-acting opioid, proposed as an anesthetic in humans. |
| Databáze: | OpenAIRE |
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