Immunotoxicology of Biological Response Modifiers

摘要: Biological response modifiers (BRMs) are natural proteins that alter immune responses and have been developed as either immunosuppressive or immunostimulating drugs. These may include products such β-glucans, biotherapeutics monoclonal antibodies. Immunotoxicity testing of these modulators is not currently regulated by International Conference on Harmonization (ICH) guidelines thus, many the standard immunotoxicity tests used for understanding pharmacology molecule. Since only cross-reactive in nonhuman primates (NHPs), need to be adapted (since rodents species small-molecule therapeutics). Unanticipated effects system related mechanism action, but would then considered immunotoxicity. Immunogenicity must also assessed, which drug. All factors make BRMs a challenge toxicologists working this field.