Immunotoxicology evaluating

Forsell, J.H., L.R. Shull, and J.R. Kateley. 1981. Subchronic administration of technical pentachlorophenol to lactating dairy cattle immunotoxicologic evaluation. Jour. Toxicol. Environ. Health 8 543-558. 

As the first published requirement for immunotoxicology evaluation of drugs, CPMPZSWP/1042/99 predictably was met with a combination of resistance and confusion. Much of this was allayed in a Drug Information Associated-sponsored workshop held in Noordwijk, The Netherlands in November of 2001. At this meeting, the intent of the guideline was clarified a summary of this workshop, as well as an update, has been published [44, 45],... 

Guidance for Industry Immunotoxicology Evaluation of Investigational New Drugs. U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER). October 2002. 

Thiem, P.A., Halper, L.K. and Bloom, J.C. (1988). Techniques for assessing canine mononuclear phagocyte function as part of an immunotoxicologic evaluation. Int. J. Immuno-pharm. 10 765-771. 

Immunotoxicology Evaluation of IND (PDF) (Issued October 2002, Posted October 31,2002).This guidance makes recommendations to sponsors of INDs on (1) the parameters that should be routinely assessed in toxicology studies to determine the effects of a drug on immune function (2) when additional immunotoxicity studies should be conducted and (3) when additional mechanistic information could help characterize the significance of a given drug s effect on the immune system. 

US FDA Guidance for Industry—Immunotoxicological Evaluation of Investigational New Drugs April, 2002. 

KAROL, M.H., STADLER, J. MAGRENI, C. (1985) Immunotoxicologic evaluation of the respiratory system animal models for immediate- and delayed-onset pulmonary hypersensitivity. Fundamental and Applied Toxicology, 5, 459-472. 

CURRENT REGULATORY EXPECTATIONS EOR IMMUNOTOXICOLOGY EVALUATION OF PHARMACEUTICALS... 

Weaver JL,Tsutsui N, Hisada S, Vidal J-M, Spanhaak S, Sawada J, Hasting KL, van der Laan JW, Van Loveren H, Kawabata TT, Sims J, Durham SK, Fueki O, Matula TI, Kusunoki H. Meeting report development of the ICH guidelines for immunotoxicology evaluation of pharmaceuticals using a survey of industry practices. J Immunotoxicol 2005 2 171-180. 

Although immunophenotyping is part of many immunotoxicologic evaluations, it is unlikely to ever be a stand-alone analysis in risk assessment because of limited applicability as a screen for immunotoxicity. Despite not being a stand-alone technique and with only a limited role in hazard identification, immunophenotyping remains an important tool in hazard characterization, primarily in understanding mechanisms of immunotoxicity. 

A few examples of animal models used in immunotoxicologic testing of drugs include Brown Norway rat and Lewis rat models, which are described in detail below. Other established mouse models of autoimmune diseases, e.g.,systemic lupus erythematosus, collagen-induced arthritis,pristane-induced arthritis and systemic scleroderma, may be considered for potential application in immunotoxicology evaluation. 

FDA. Immunotoxicology Evaluation of Investigational New Drugs. 2002. Available at http //www.fda.gov/cder/guidance/4945fnl.pdf... 

Kenneth L. Hastings, DrPH, DABT, Associate Vice-President for Regulatory Policy, Sanofi-Aventis, 4520 East West Highway, Suite 210, Bethesda, MD 20814, E-mail kenneth.hastings sanofi-aventis.com Chapter 1 Current Regulatory Expectations for Immunotoxicology Evaluation of Pharmaceuticals... 

Johnson KW, Holsapple MP, Munson AE. 1986. An immunotoxicological evaluation of gammachlordane. Fundam AppI Toxicol 6 317-326. 

Sakazaki, H. Ueno, H. Umetani, K. Utsumi, H. Nakamuro, K. Immunotoxicological evaluation of environmental chemicals utilizing mouse lymphocyte mitogenesis test. J. Health Sci. 2001,47, 258-271. 

One aspect of immunotoxicological evaluation includes assessment of potential immunogenicity (see section 3.6). Many biotechnology-derived pharmaceuticals are intended to stimulate or... 

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