Introduction: Interest in developmental immunotoxicology has been stimulated following suggestions over recent years that xenobiotics may be capable of influencing the human immune system in such a way as to render the population more vulnerable to diseases.
The possible manifestations of immunotoxicity include reduced resistance to infectious diseases, more frequent virus-associated malignancies, increased susceptibility to allergy or idiopathic autoimmune diseases, drug-induced hypersensitivity and drug-induced autoimmunity.
Serum cytokine, immunoglobulin, autoantibody levels measurements are included among routine immune assessments in an ICH pre- and post-natal developmental toxicology study.
Aim of the study: The aim of the present study phase was to perform analyses to detect total IgA, IgG and IgM concentra-tion in rabbit serum samples.
Analyte: Rabbit IgA, Rabbit IgG, Rabbit IgM
Methodology: ELISA methods for the quantification of IgA, IgG and IgM in rabbit serum samples.
System: Pregnant rabbit
Therapeutic area: Autoimmune diseases
Development stage: Preclinical
Regulatory compliance: GLP
Customer: A large pharma company focused on the development of drugs to treat immune disorders.
Results: Toxicokinetic data in pregnant New Zealand White rabbits treated every other day by subcutaneous route from day 6 to day 26 of pregnancy.
Three analytical ELISA methods to detect IgA, IgG and IgM in rabbit serum samples were set up and validated for application in PK/PD studies under GLP requirements.