Drug-induced hypersensitivity: role in drug development
Drug-induced hypersensitivity is an adverse reaction, characterised by damaging immune-mediated responses, initiated by medicine given at therapeutic doses for prevention, diagnosis or treatment. Immune-mediated drug hypersensitivity accounts for 6-10% of the adverse drug reactions, which rank between the fourth and sixth leading causes of death in the US. With <10% of all adverse drug reactions reported, the magnitude of the problem is significant, with estimates of costs >$US30 billion annually in the US (1995 value). In addition, the costs of not determining the potential of a drug to produce hypersensitivity in the pre-clinical phase of drug development can be substantial. It has been estimated that the pre-clinical phase and clinical phase I, phase II and phase III costs are approximately $US6 million, $US12 million, $US12 million and $US100 million per drug, respectively (1999 values). It is important that investigational drugs with the potential to produce hypersensitivity reactions be identified as early in the development process as possible. Some adverse reactions to drugs can be avoided if drug-drug interactions are known or if there is a structure-activity relationship established. However, these methods are inadequ...Continue Reading
Surgical influence on murine immunity and tumor growth: relationship of body temperature and hormones with splenocytes
The role of leukocyte-generated reactive metabolites in the pathogenesis of idiosyncratic drug reactions
Role of the pineal gland in immunity. Circadian synthesis and release of melatonin modulates the antibody response and antagonizes the immunosuppressive effect of corticosterone
Definition of the pulmonary antibody response to ovalbumin following local challenge in systemically immunized rats
Development and validation of an alternative dermal sensitization test: the mouse ear swelling test (MEST)
Homologous and heterologous passive cutaneous anaphylactic activity of mouse antisera during the course of immunization
Optimization and validation of an ELISA to measure specific guinea pig IgG1 antibody as an alternative to the in vivo passive cutaneous anaphylaxis assay
Contact sensitization assays in guinea-pigs: are they predictive of the potential for systemic allergic reactions?
Structure-activity relationships for skin sensitization potential: development of structural alerts for use in knowledge-based toxicity prediction systems
Respiratory and immunological responses of guinea pigs to enzyme-containing detergents: a comparison of intratracheal and inhalation modes of exposure
Structure-activity relationships and computer-assisted analysis of respiratory sensitization potential
An alternative strategy to the use of guinea pigs for the identification of skin sensitization hazard
The mouse IgE test for the identification of potential chemical respiratory allergens: considerations of stability and controls
The use of reporter antigens in the popliteal lymph node assay to assess immunomodulation by chemicals
Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies
Adverse drug reactions in Sjögren's syndrome. Frequent allergic reactions and a specific trimethoprim-associated systemic reaction
Immunological principles of adverse drug reactions: the initiation and propagation of immune responses elicited by drug treatment
Pre-clinical methods for detecting the hypersensitivity potential of pharmaceuticals: regulatory considerations
Oral administration of drugs with hypersensitivity potential induces germinal center hyperplasia in secondary lymphoid organ/tissue in Brown Norway rats, and this histological lesion is a promising candidate as a predictive biomarker for drug hypersensitivity occurrence in humans
Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.
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