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The TDAR Assay in Nonclinical Studies of Pharmaceuticals and Chemicals: Study Design, Data Analysis, Interpretation

Henson, Kristin and Lebrec, H and Molinier, B and Boverhof, D and Collinge, M and Freebern, W and Mytych, D and Ochs, H and Wange, R and Yang, Y and Zhou, L and Arrington, J and Christin-Piche, M and Shenton, J (2014) The TDAR Assay in Nonclinical Studies of Pharmaceuticals and Chemicals: Study Design, Data Analysis, Interpretation. Regulatory Toxicology and Pharmacology, 69. pp. 7-21.

Abstract

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, in research and by regulatory agencies. It is also employed to evaluate investigational drug efficacy in animal pharmacology studies, to provide evidence of biological impact in clinical trials, and to evaluate immune function in patients with primary or secondary immunodeficiency diseases. Various immunization schemes, analytical methods, approaches to data analysis, and data interpretation are in use, raising concerns that data generated under different conditions may not be comparable. This manuscript summarizes some recommended practices for the conduct and interpretation of the assay in animal studies.

Item Type: Article
Keywords: TDAR, Nonclinical studies, Immunotoxicity
Date Deposited: 13 Oct 2015 13:13
Last Modified: 13 Oct 2015 13:13
URI: https://oak.novartis.com/id/eprint/20292

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