REFERENCES
- CPMP. Committee on Proprietary Medicinal Products. 2000, http://www.emea.eu.int CPMP/SWP/1042/99, Note for Guidance on Repeated-Dose Toxicity
- EPA. United States Environmental Protection Agency. Health Effects Test Guidelines: Immunotoxicity. 1998, http://www.epa.gov/opptsfrs/publications OPPTS 870.7800
- FDA. United States Food and Drug Administration. Guidance for Industry: Immunotoxicology Evaluation of Investigational New Drugs. 2002, http://www.fda.gov/cder/guidance
- Gore E. R., Gower J., Kurali E., Sui J. L., Bynum J., Ennulat D., Herzyk D. Primary antibody response to keyhole limpet hemocyanin in rat as a model for immunotoxicity evaluation. Toxicology 2004; 197: 23–35
- Herzyk D. J., Gore E. R. Adequate immunotoxicity testing in drug development. Toxicol. Lett. 2004; 149: 115–122
- ICH. International Conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. 2006, ICH Harmonised Tripartite Guideline Immunotoxicity Studies For Human Pharmaceuticals S8.
- Ladics G. S., Smith C., Elliott G. S., Slone T. W., Loveless S. E. Further evaluation of the incorporation of an immunotoxicological functional assay for assessing humoral immunity for hazard identification purposes in rats in a standard toxicology study. Toxicology 1998; 126: 137–152
- Luster M. I., Munson A. E., Thomas P. T., Holsapple M. P., Fenters J. D., White K. L., Jr., Lauer L. D., Germolec D. R., Rosenthal G. J., Dean J. H. Development of a testing battery to assess chemical-induced immunotoxicity: National Toxicology Program's guidelines for immunotoxicity evaluation in mice. Fundam. Appl. Toxicol. 1988; 10: 2–19
- Luster M. I., Portier C., Pait D. G., Rosenthal G. J., Germolec D. R., Corsini E., Blaylock B. L., Pollock P., Kouchi Y., Craig W., White K. L., Jr., Munson A. E., Comment C. E. Risk assessment in immunotoxicology. II. Relationships between immune and host resistance tests. Fundam. Appl. Toxicol. 1993; 21: 71–82
- Luster M. I., Portier C., Pait D. G., White K. L., Jr., Gennings C., Munson A. E., Rosenthal G. J. Risk assessment in immunotoxicology. I. Sensitivity and predictability of immune tests. Fundam. Appl. Toxicol. 1992; 18: 200–210
- Temple L., Kawabata T. T., Munson A. E., White K. L., Jr. Comparison of ELISA and plaque-forming cell assay for measuring the humoral immune response to SRBC in animals treated with benzo(a)pyrene or cyclophosphamide. Fundam. Appl. Toxicol. 1993; 21: 412–419