Journal
TOXICOLOGIC PATHOLOGY
Volume 38, Issue 7, Pages 1111-1117Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/0192623310382436
Keywords
developmental immunotoxicology; immunotoxicology; histopathology; therapeutic monoclonal antibodies; mice
Categories
Funding
- Investigational Toxicology and Pathology Interest Group
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Developmental immunotoxicity (DIT) has gained attention with the recognition that environmental chemicals can potentially affect the developing immune system and the incidence of childhood allergic diseases. Preclinical safety assessment of pharmaceuticals for men and women of childbearing potential as well as for pediatric and juvenile indications may require DIT assessments. Draft documents from environmental and chemical regulatory agencies propose strategies that use the rat as a test species and incorporate histopathology and functional testing as endpoints. While there are no guidelines for DIT assessment of pharmaceuticals, current discussions suggest that combining immunotoxicity and developmental and reproductive toxicology studies may serve this purpose. Knowledge of the principles and applications of DIT will facilitate participation in strategy development and effective conduct of relevant studies.
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