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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

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

Copyright © 2014 Elsevier Inc. All rights reserved.

KEYWORDS:

Immunotoxicity; Nonclinical studies; TDAR

PMID:
24566336
[PubMed - indexed for MEDLINE]
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