Survey results on the use of the tissue cross-reactivity immunohistochemistry assay

Regulatory Toxicology and Pharmacology

Volumn 59, Issue 3, 2011, Pages 493-502

  Bussiere, Jeanine L ^a   Leach, Michael W ^b   Price, Karen D ^c   Mounho, Barbara J ^a   Lightfoot Dunn, Ruth ^a  

^a AMGEN INC   (United States)

^b PFIZER INC   (United States)

^c BRISTOL MYERS SQUIBB COMPANY   (United States)

Author keywords

Cynomolgus monkey tissues; Human tissues; Immunohistochemistry; Tissue cross reactivity

Indexed keywords

ANTIBODY CONJUGATE; MONOCLONAL ANTIBODY;

ARTICLE; ASSAY; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG SAFETY; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; GOVERNMENT REGULATION; HISTOPATHOLOGY; IMMUNOHISTOCHEMISTRY; PRIORITY JOURNAL; TISSUE CROSS REACTIVITY ASSAY; TOXICITY TESTING;

ANIMALS; BIOPHARMACEUTICS; BIOTECHNOLOGY; CROSS REACTIONS; DRUG DELIVERY SYSTEMS; DRUG INDUSTRY; HEALTH SURVEYS; HUMANS; IMMUNOHISTOCHEMISTRY; INTERNET; MACACA FASCICULARIS; MICE; PHARMACEUTICAL PREPARATIONS; TISSUE DISTRIBUTION;

ANIMALIA; MACACA FASCICULARIS; PRIMATES;

EID: 79952698367     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2010.09.017     Document Type: Article

References (4)

1. ICH S6: Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals, 1997. Accessed 6/24/2010 at http://www.ich.org.
2. FDA Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997. Accessed 6/24/2010 at http://www.fda.gov.
3. Gosse M.E., Manocchia M. The first biopharmaceuticals approved in the United States: 1980-1994. Drug Information J. 1996, 30:991-1001.
4. Leach, M.W., Halpern, W.G., Johnson, C.W., Roiko, J.L., MacLachlan, T.K., Chan, C.M., Galbreath, E.J., Ndifor, A.M., Blanset, D.L., Polack, E., Cavagnaro, J.A., 2010. Use of tissue cross-reactivity studies in the development of antibody-based biopharmaceuticals: history, experience, methodology, and future directions. doi:10.1177/01926223310382559.