{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,6,8]],"date-time":"2024-06-08T00:07:09Z","timestamp":1717805229724},"reference-count":42,"publisher":"Elsevier","isbn-type":[{"value":"9780124171442","type":"print"}],"license":[{"start":{"date-parts":[[2015,1,1]],"date-time":"2015-01-01T00:00:00Z","timestamp":1420070400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015]]},"DOI":"10.1016\/b978-0-12-417144-2.00034-2","type":"book-chapter","created":{"date-parts":[[2015,3,20]],"date-time":"2015-03-20T20:02:04Z","timestamp":1426881724000},"page":"649-668","source":"Crossref","is-referenced-by-count":0,"title":["Considerations Regarding the Future Use of Nonhuman Primates to Support the Clinical Development of Biopharmaceuticals"],"prefix":"10.1016","author":[{"given":"Joy A.","family":"Cavagnaro","sequence":"first","affiliation":[]},{"given":"Beatriz Silva","family":"Lima","sequence":"additional","affiliation":[]}],"member":"78","reference":[{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0010","series-title":"Preclinical safety evaluation of biopharmaceuticals: a science-based approach to facilitating clinical trials","first-page":"45","article-title":"The principles of ICH S6 and the case-by-case approach","author":"Cavagnaro","year":"2008"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0015","unstructured":"ICH S6. International Conference on Harmonisation (ICH) S6: preclinical safety evaluation of biotechnology-derived pharmaceuticals, July 1997."},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0020","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1016\/j.yrtph.2011.10.016","article-title":"The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates","volume":"62","author":"Chapman","year":"2012","journal-title":"Regul Toxicol Pharmacol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0025","author":"ICH S6 (R1)"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0030","doi-asserted-by":"crossref","first-page":"325","DOI":"10.1038\/nrd3003","article-title":"The safety and side effects of monoclonal antibodies","volume":"9","author":"Hansel","year":"2010","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0035","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1038\/nrd822","article-title":"Preclinical safety evaluation of biotechnology-derived pharmaceuticals","volume":"1","author":"Cavagnaro","year":"2002","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0040","doi-asserted-by":"crossref","first-page":"882","DOI":"10.1038\/nbt.2709","article-title":"The value of non-human primates in the development of monoclonal antibodies","volume":"31","author":"Van Meer","year":"2013","journal-title":"Nat Biotechnol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0045","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1163\/156939105774647385","article-title":"Non-human primates in medical research and drug development: a critical review","volume":"19","author":"Bailey","year":"2005","journal-title":"Biog Amines"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0050","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1002\/ddr.21173","article-title":"Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases","volume":"75","author":"Brennan","year":"2013","journal-title":"Drug Dev Res"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0055","doi-asserted-by":"crossref","first-page":"306","DOI":"10.1038\/nrd3974","article-title":"Challenges and approaches for the development of safer immunomodulatory biologics","volume":"12","author":"Sathish","year":"2013","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0060","author":"ICH M3 (R2)"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0065","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1016\/j.yrtph.2010.09.017","article-title":"Survey results on the use of the tissue cross-reactivity immunohistochemistry assay","volume":"59","author":"Bussiere","year":"2010","journal-title":"Reg Tox and Pharm"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0070","doi-asserted-by":"crossref","first-page":"1138","DOI":"10.1177\/0192623310382559","article-title":"Use of tissue cross-reactivity studies in the development of antibody-based biopharmaceuticals: history, experience, methodology, and future directions","volume":"38","author":"Leach","year":"2010","journal-title":"Toxicol Pathol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0075","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1177\/1091581811415875","article-title":"Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals","volume":"30","author":"Buckley","year":"2011","journal-title":"Int J Toxicol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0080","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1016\/j.yrtph.2010.10.005","article-title":"Safety evaluation of biological drugs: what are toxicology studies in primates telling use?","volume":"59","author":"Baldrick","year":"2011","journal-title":"Regul Toxicol Pharmacol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0085","author":"ICH S5 (R2)"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0090","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1002\/bdrb.20197","article-title":"Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals","volume":"86","author":"Martin","year":"2009","journal-title":"Birth Defects Res (Part B)"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0095","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1002\/(SICI)1096-9926(199603)53:3<185::AID-TERA6>3.0.CO;2-3","article-title":"Reproductive toxicity testing of therapeutic biotechnology agents","volume":"53","author":"Henck","year":"1996","journal-title":"Teratology"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0100","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1002\/bdrb.20179","article-title":"Comparative effects of interferon alpha-2b and pegylated interferon alpha-2b on menstrual cycles and ovarian hormones in cynomolgus monkeys","volume":"86","author":"Enright","year":"2009","journal-title":"Birth Defects Res (Part B)"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0105","author":"FDA"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0110","doi-asserted-by":"crossref","first-page":"2379","DOI":"10.1007\/s11095-011-0523-5","article-title":"Immunogenicity of therapeutic proteins: the use of animal models","volume":"28","author":"Brinks","year":"2001","journal-title":"Pharm Res"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0115","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1016\/0272-0590(91)90112-H","article-title":"Comparison of the immunogenicity of recombinant and pituitary human growth hormone in rhesus monkeys","volume":"16","author":"Zwickl","year":"1991","journal-title":"Fundam Appl Toxicol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0120","series-title":"Preclinical safety evaluation of biopharmaceuticals: a science-based approach to facilitating clinical trials","first-page":"537","article-title":"Toxicity of oligonucleotide therapeutics","author":"Levin","year":"2008"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0125","series-title":"Preclinical safety evaluation of biopharmaceuticals: a science-based approach to facilitating clinical trials","article-title":"Enzyme replacement therapies","author":"Andrews","year":"2008"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0130","doi-asserted-by":"crossref","first-page":"S82","DOI":"10.1590\/1516-4446-2013-1157","article-title":"Animal models of neurodegenerative diseases","volume":"35","author":"Ribeiro","year":"2013","journal-title":"Rev Bras Psiquiatr"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0135","doi-asserted-by":"crossref","first-page":"224","DOI":"10.1002\/ana.20549","article-title":"Trophic factor distribution predicts functional recovery in parkisonian monkeys","volume":"8","author":"Gash","year":"2005","journal-title":"Ann Neurol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0140","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1016\/j.expneurol.2006.07.015","article-title":"Point source concentration of GDNF may explain failure of phase II clinical trial","volume":"202","author":"Salvatore","year":"2006","journal-title":"Exp Neurol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0145","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1177\/01926230701481899","article-title":"Six-month continuous intraputamenal infusion toxicity study of recombinant methionyl human glial cell line-derived neurotrophic factor (r-metHuGDNF) in rhesus monkeys","volume":"35","author":"Hovland","year":"2007","journal-title":"Toxicol Pathol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0150","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.nbd.2011.05.026","article-title":"Properly scaled and targeted AAV2-NRTN (neurturin) to the substantia nigra is safe, effective and causes no weight loss: support for nigral targeting in Parkinson's Disease","volume":"44","author":"Bartus","year":"2011","journal-title":"Neurobiol Dis"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0155","unstructured":"Directive 2010\/63\/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, 2010."},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0160","author":"FDA"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0165","series-title":"Comprehensive toxicology","first-page":"29","article-title":"Considerations in the preclinical development of biopharmaceuticals","volume":"vol. 3","author":"Cavagnaro","year":"2010"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0170","series-title":"Global approach in safety testing: ICH guidelines explained","first-page":"215","article-title":"ICH S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals","author":"Cavagnaro","year":"2013"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0175","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1016\/j.yrtph.2007.08.001","article-title":"Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?","volume":"50","author":"Clarke","year":"2008","journal-title":"Regul Toxicol Pharmacol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0180","series-title":"New developments and challenges in primate toxicology","first-page":"9","article-title":"Predicting clinical immunogenicity: intended or unintended","author":"Frings","year":"2005"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb0195","doi-asserted-by":"crossref","first-page":"S52","DOI":"10.1177\/1091581810378896","article-title":"Developmental toxicity testing of biopharmaceuticals in nonhuman primates: previous experience and future directions","volume":"29","author":"Martin","year":"2010","journal-title":"Int J Toxicol"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb9000","first-page":"89","article-title":"Rationality and regulatory requirements-a view from Britain","volume":"vol. 235","author":"Dayan","year":"1987"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb9005","first-page":"161","article-title":"Genetically engineered drugs: toxicology with a difference","volume":"vol. 235","author":"Finkle","year":"1987"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb9010","first-page":"143","article-title":"Biotechnology products intended for human use, toxicological targets and research strategies","volume":"vol. 235","author":"Zbinden","year":"1987"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb9015","doi-asserted-by":"crossref","first-page":"294","DOI":"10.1111\/j.1600-065X.2009.00776.x","article-title":"Translating co-stimulatory blockade to the clinic: lessons learned from three pathways","volume":"229","author":"Ford","year":"2009","journal-title":"Immunol Rev"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb9020","doi-asserted-by":"crossref","first-page":"555","DOI":"10.1038\/nbt1303","article-title":"A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs","volume":"25","author":"Shankar","year":"2007","journal-title":"Nat Biotech"},{"key":"10.1016\/B978-0-12-417144-2.00034-2_bb9025","doi-asserted-by":"crossref","first-page":"170","DOI":"10.1093\/ilar.45.2.170","article-title":"Hormonal therapies and osteoporosis","volume":"45","author":"Jerome","year":"2004","journal-title":"ILAR J"}],"container-title":["The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:B9780124171442000342?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:B9780124171442000342?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,6,7]],"date-time":"2024-06-07T23:24:44Z","timestamp":1717802684000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/B9780124171442000342"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015]]},"ISBN":["9780124171442"],"references-count":42,"URL":"https:\/\/doi.org\/10.1016\/b978-0-12-417144-2.00034-2","relation":{},"subject":[],"published":{"date-parts":[[2015]]}}}