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Immunotoxicity testing in non-rodent species.

Helen G Haggerty¹

¹Bristol-Myers Squibb, Syracuse, New York 13221, USA. helen.haggerty@bms.com

Journal of Immunotoxicology

|October 30, 2008

Summary

Evaluating drug immunotoxicity requires moving beyond rodents. Immune function tests in non-human primates and dogs, including TDAR and lymphocyte phenotyping, are crucial for comprehensive drug safety assessment.

Area of Science:

Pharmacology and Toxicology
Immunology
Veterinary Medicine

Background:

Rodent models are insufficient for evaluating the immunotoxicity of pharmaceuticals.
Non-rodent species, such as non-human primates and dogs, offer valuable alternatives for immunotoxicity testing.
Immune function assays are essential components of drug safety assessment.

Purpose of the Study:

To review the application of immune function tests in non-rodent species for drug safety evaluation.
To discuss the interpretation and limitations of these assays in assessing pharmaceutical immunotoxicity.
To highlight the importance of diverse species in comprehensive toxicological studies.

Main Methods:

Review of existing literature on immune function testing in non-rodent species.

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Description of various immune assays, including T-cell dependent antibody response (TDAR), lymphocyte phenotyping, natural-killer cell activity, delayed-type hypersensitivity, and macrophage function assays.

Analysis of approaches for incorporating these tests into drug development.

Main Results:

Immune function tests in non-rodent species provide critical data for drug safety assessment.
Specific assays like TDAR and lymphocyte phenotyping reveal potential immunomodulatory effects.
Interpretation of results requires careful consideration of species-specific responses and assay limitations.

Conclusions:

Expanding immunotoxicity testing to non-rodent species is vital for accurate drug safety evaluation.
A multi-species approach enhances the detection of potential adverse immune effects from pharmaceuticals.
Further research is needed to refine and standardize immune function assays in non-rodent models.