Food and Drug Administration Risk Assessment—Process and Toxicologic Pathology-Reference-Cited by-同舟云学术

Food and Drug Administration Risk Assessment—Process and Toxicologic Pathology

Published:1997-01 Issue:1 Volume:25 Page:61-67
ISSN:0192-6233
Container-title:Toxicologic Pathology
language:en
Short-container-title:Toxicol Pathol

Author:

Moch Ronald W.¹,Dua Prem N.¹,Hines Fred A.¹

Affiliation:

1. Pathology Branch, Division of General Scientific Support, Office of Scientific Analysis and Support, Center for Food Safety and Applied Nutrition, U. S. Food and Drug Administration, 200 C Street, SW, Washington, D. C. 20204

Abstract

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.

Publisher

SAGE Publications

Subject

Cell Biology,Toxicology,Molecular Biology,Pathology and Forensic Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1177/019262339702500112

Reference12 articles.

1. Review of Pathology Data for Regulatory Purposes

2. Flamm WG and Lorentzen RJ (1988). Quantitative risk assessment (QRA): A special problem in the approval of new products. In: Risk Assessment and Risk Management of Industrial and Environmental Chemicals, Advances in Modern Environmental Toxicology, Vol. XV, CR Cothern, MA Mehlman, and WL Marcus (eds). Princeton Scientific Publishing, Princeton, New Jersey, pp. 91-108.

3. Kokoski CJ and Flamm WG (1984). Establishment of acceptable limits of intake. In: Proceedings of the Second National Conference for Food Protection . U.S. Department of Health and Human Services, FDA, Washington, D.C., May 9-11, pp. 61-72.

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