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Regul Toxicol Pharmacol. 2014 Jun;69(1):7-21. doi: 10.1016/j.yrtph.2014.02.008. Epub 2014 Feb 22.

The T-cell-dependent antibody response assay in nonclinical studies of pharmaceuticals and chemicals: study design, data analysis, interpretation.

Author information

1
Amgen, Seattle, WA, USA. Electronic address: hlebrec@amgen.com.
2
Sanofi-Aventis R&D, Montpellier, France.
3
The Dow Chemical Company, Midland, MI, USA.
4
Pfizer, Inc., Groton, CT, USA.
5
Bristol-Myers Squibb Company, New Brunswick, NJ, USA.
6
Novartis Institutes for Biomedical Research Inc., East Hanover, NJ, USA.
7
Amgen, Thousand Oaks, CA, USA.
8
Department of Pediatrics, University of Washington, and Seattle Children's Research Institute, Seattle, WA, USA.
9
Food and Drug Administration, Silver Spring, MD, USA.
10
Office of Pesticides Programs, US Environmental Protection Agency, Washington, DC, USA.
11
Covance Inc., Madison, WI, USA.
12
Charles River Laboratories, Montreal, Canada.
13
MedImmune Ltd., Cambridge, UK.

Abstract

The T-cell-dependent antibody response (TDAR) assay is a measure of immune function that is dependent upon the effectiveness of multiple immune processes, including antigen uptake and presentation, T cell help, B cell activation, and antibody production. It is used for risk and safety assessments, in conjunction with other toxicologic assessments, by the chemical and pharmaceutical industries, and research and regulatory agencies. It is also employed to evaluate investigational drug efficacy in animal pharmacology studies, provide evidence of biological impact in clinical trials, and evaluate immune function in patients with primary or secondary immunodeficiency diseases. Various immunization schemes, analytical methods, approaches to data analysis, and data interpretations are in use. This manuscript summarizes some recommended practices for the conduct and interpretation of the assay in animal studies.

KEYWORDS:

Immunotoxicity; Nonclinical studies; TDAR

PMID:
24566336
DOI:
10.1016/j.yrtph.2014.02.008
[Indexed for MEDLINE]
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