An inter-laboratory retrospective analysis of immunotoxicological endpoints in non-human primates: T-cell-dependent antibody responses

Journal of Immunotoxicology

Volumn 8, Issue 3, 2011, Pages 238-250

  Lebrec, Hervé ^a   Cowan, Laine ^a   Lagrou, Michelle ^a   Krejsa, Cecile ^b   Neradilek, Moni B ^c   Polissar, Nayak L ^c   Black, Lauren ^d   Bussiere, Jeanine ^e  

^a AMGEN INC   (United States)

^b Applied Pharmacology LLC   (United States)

^c Mountain Whisper Light Statistics   (United States)

^d CHARLES RIVER LABORATORIES   (United States)

^e AMGEN INC   (United States)

Author keywords

cynomolgus macaque; immunotoxicology; TDAR

Indexed keywords

FREUND ADJUVANT; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; IMMUNOLOGICAL ADJUVANT; KEYHOLE LIMPET HEMOCYANIN; TETANUS TOXOID;

ANIMAL EXPERIMENT; ANTIBODY RESPONSE; ANTIBODY TITER; FEMALE; GENDER; IMMUNIZATION; INDONESIA; MALE; MAURITIUS; NONHUMAN; PHILIPPINES; PRIMATE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; REVIEW; SHEEP ERYTHROCYTE; T LYMPHOCYTE;

ANIMALS; ANTIBODY FORMATION; DATA INTERPRETATION, STATISTICAL; ENDPOINT DETERMINATION; ERYTHROCYTES; FEMALE; HEMOCYANIN; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; IMMUNOLOGIC TECHNIQUES; MACACA FASCICULARIS; MALE; RESEARCH DESIGN; SHEEP; SPECIES SPECIFICITY; T-LYMPHOCYTES; TETANUS TOXOID; TOXICOLOGY;

ANIMALIA; OVIS ARIES; PRIMATES;

EID: 79961008958     PISSN: 1547691X     EISSN: None     Source Type: Journal    
DOI: 10.3109/1547691X.2011.587473     Document Type: Review

References (12)

1. Caldwell, R., Guirguis, M., and Kornbrust, E. 2007. Evaluation of various keyhole limpet hemocyanin dosing regimens for the cynomolgus monkey TDAR assay. The Toxicologist. Abstract #1723
2. CPMP (Committee for Proprietary Medicinal products). 2000. Note for Guidance on Repeated Dose Toxicity. CPMP/SWP/1042/99.
3. Feldmann, M. 1996. Cell cooperation in the antibody response. In: Immunology Fourth Edition (Roitt, I. M., Brostof, J., and Male, D. K., Eds.), New York: Mosby, pp. 8.1-8.16.
4. FDA (Food and Drug Administration, Center for Drug Evaluation and Research). 2002. Guidance for Industry. Immunotoxicology Evaluation of Investigational New Drugs. Washington, DC.
5. Haggerty, H. G. 2007. Immunotoxicity testing in non-rodent species. J. Immunotoxicol. 4:165-169. (Pubitemid 46897803)
6. ICH (International Conference on Harmonization). 2006. Guidance for Industry. S8 Immunotoxicity Studies for Human Pharmaceuticals. Washington, DC.
7. Kirk, S. A., Fraser, S. R., Gordon, D., and Templeton, A. 2008. Evaluation of the T-cell dependent antibody response (TDAR) to tetanus toxoid (TT), in the cynomolgus monkey, in the presence of a known immunosuppressant. The Toxicologist. Abstract #2134.
8. Luster, M. I., Portier, C., Pait, D. G., White, K. L., Jr, Gennings, C., Munson, A. E., and Rosenthal, G. J. 1992. Risk assessment in immunotoxicology. I. Sensitivity and predictability of immune tests. Fundam. Appl. Toxicol. 18:200-210.
9. Luster, M. I., Portier, C., Pait, D. G., Rosenthal, G. J., Germolec, D. R., Corsini, E., Blaylock, B. L., Pollock, P., Kouchi, Y., and Craig, W. 1993. Risk assessment in immunotoxicology. II. Relationships between immune and host resistance tests. Fundam. Appl. Toxicol. 21:71-82. (Pubitemid 23225987)
10. Picotti, J. R. 2008. T-Cell-dependent antibody response tests. In: Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Danuta J. H., and Bussiere J., Eds.), New York: John Wiley and Sons Inc., pp. 67-76.
11. Piccotti, J. R., Alvey, J. D., Reindel, J. F., and Guzman, R. E. 2005. T-cell-dependent antibody response: Assay development in cynomolgus monkeys. J. Immunotoxicol. 2:191-196. (Pubitemid 41789901)
12. Tichenor, J. N., Dumont, C., Coletti, K. S., LeSauteur, L., Calise, D. V., Christn-Piche, M. S., and Satterwhite, C. 2010. A 6-week study to determine the antibody response to FK-506-immunosuppressed cynomolgus monkeys following the subcutaneous administration of keyhole limpet hemocyanin and tetanus toxoid in the presence or absence of incomplete Freud's adjuvant. The Toxicologist. Abstract #1989.