Nonhuman primates immunotoxicity testing

Grote-Wessels S et al (2010) Immunotoxicity testing in nonhuman primates. In Dietert R (ed) Immunotoxicity testing methods and protocols. Springer, New York, pp 341-359... 

Several important factors should be considered when including immunotoxicity testing into GLP (good laboratory practice) toxicology studies, especially if they are conducted in nonhuman primates. These include (1) whether... 

Methods for evaluating immunotoxicity in rodents are well established and are the basis of the ICH S8 guidance (ICH, 2006). Many of these methods have been adapted for use in developmental immunotoxicity studies in rodents (Dietert and Holsapple, 2007). Immunotoxicity testing in nonhuman primates, and in particular developmental immunotoxicity, has been requested by regulatory agencies for immunobiotherapeutics but the methods to date are not well established for nonhuman primates and vary to some extent from study to study. 

Clearly the nonhuman primate can provide valuable and relevant information on the effects of human therapeutics on the development of the immune system. In order to optimize the use of animals and to obtain the most meaningful information for the human therapeutic, each study may need to be designed on a case-by-case basis. Nevertheless, there is a need for greater standardization of the tests used to evaluate immunotoxicity in nonhuman primates. 

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