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Volumn 28, Issue 2, 2009, Pages 220-225

Developmental toxicity testing of monoclonal antibodies: An enhanced pre- and postnatal study design option

Author keywords

Cynomolgus monkey; Developmental toxicity study designs; Monoclonal antibodies

Indexed keywords

GOLIMUMAB; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; PANITUMUMAB;

EID: 67650627735     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.reprotox.2009.04.002     Document Type: Article
Times cited : (57)

References (28)
  • 1
    • 67650639675 scopus 로고    scopus 로고
    • ICH S5 Guidance on Reproductive Toxicology and Male Fertility: Detection of Toxicity to Reproduction for Medicinal Products. Fed Reg 1994;59:48746-52.
    • ICH S5 Guidance on Reproductive Toxicology and Male Fertility: Detection of Toxicity to Reproduction for Medicinal Products. Fed Reg 1994;59:48746-52.
  • 2
    • 0036593951 scopus 로고    scopus 로고
    • Preclinical safety evaluation of biotechnology-derived pharmaceuticals
    • Cavagnaro J.A. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Nat Rev Drug Discov 1 (2002) 469-475
    • (2002) Nat Rev Drug Discov , vol.1 , pp. 469-475
    • Cavagnaro, J.A.1
  • 4
    • 33947587491 scopus 로고    scopus 로고
    • Preclinical safety testing of monoclonal antibodies: the significance of species relevance
    • Chapman K., Pullen N., Graham M., and Ragan I. Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat Rev Drug Discov 6 (2007) 120-126
    • (2007) Nat Rev Drug Discov , vol.6 , pp. 120-126
    • Chapman, K.1    Pullen, N.2    Graham, M.3    Ragan, I.4
  • 6
    • 84891515955 scopus 로고    scopus 로고
    • Reproductive/developmental toxicity assessment of biopharmaceuticals in nonhuman primates
    • Cavagnaro J.A. (Ed), John Wiley & Sons, New Jersey
    • Weinbauer G.F., Frings W., Fuchs A., Niehaus M., and Osterburg I. Reproductive/developmental toxicity assessment of biopharmaceuticals in nonhuman primates. In: Cavagnaro J.A. (Ed). Preclinical safety evaluation of biopharmaceuticals (2008), John Wiley & Sons, New Jersey 379-398
    • (2008) Preclinical safety evaluation of biopharmaceuticals , pp. 379-398
    • Weinbauer, G.F.1    Frings, W.2    Fuchs, A.3    Niehaus, M.4    Osterburg, I.5
  • 8
    • 67650589428 scopus 로고    scopus 로고
    • EMEA/CHMP/203927/2005. Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling.
    • EMEA/CHMP/203927/2005. Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling.
  • 9
    • 34548229364 scopus 로고    scopus 로고
    • FcRn: the neonatal Fc receptor comes of age
    • Roopenian D.C., and Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 7 (2007) 715-725
    • (2007) Nat Rev Immunol , vol.7 , pp. 715-725
    • Roopenian, D.C.1    Akilesh, S.2
  • 10
    • 0029828069 scopus 로고    scopus 로고
    • Evaluation of maternofetal transport of immunoglobulins during human pregnancy
    • Malek A., Sager R., Kuhn P., Nicholaides K.H., and Schneider H. Evaluation of maternofetal transport of immunoglobulins during human pregnancy. Am J Reprod Immunol 36 (1996) 248-255
    • (1996) Am J Reprod Immunol , vol.36 , pp. 248-255
    • Malek, A.1    Sager, R.2    Kuhn, P.3    Nicholaides, K.H.4    Schneider, H.5
  • 11
    • 0029610704 scopus 로고
    • Materno-fetal immunoglobulin transfer and passive immunity during the first trimester of human pregnancy
    • Jauniaux E., Jurkovic D., Gulbis B., Liesnard C., Lees C., and Campbell S. Materno-fetal immunoglobulin transfer and passive immunity during the first trimester of human pregnancy. Hum Reprod 10 (1995) 3297-3300
    • (1995) Hum Reprod , vol.10 , pp. 3297-3300
    • Jauniaux, E.1    Jurkovic, D.2    Gulbis, B.3    Liesnard, C.4    Lees, C.5    Campbell, S.6
  • 12
    • 0020774246 scopus 로고
    • The placental transfer of IgG in the cynomolgus monkey
    • Fujimoto K., Terao K., Cho F., and Honjo S. The placental transfer of IgG in the cynomolgus monkey. Japan J Med Sci Biol 36 (1983) 171-176
    • (1983) Japan J Med Sci Biol , vol.36 , pp. 171-176
    • Fujimoto, K.1    Terao, K.2    Cho, F.3    Honjo, S.4
  • 13
    • 0028363988 scopus 로고
    • Maternal-fetal transport of immunoglobulin G and its subclasses during the third trimester of human pregnancy
    • Malek A., Sager R., and Schneider H. Maternal-fetal transport of immunoglobulin G and its subclasses during the third trimester of human pregnancy. Am J Reprod Immunol 32 (1994) 8-14
    • (1994) Am J Reprod Immunol , vol.32 , pp. 8-14
    • Malek, A.1    Sager, R.2    Schneider, H.3
  • 14
    • 0031986158 scopus 로고    scopus 로고
    • 1998 Placental transport of maternal immunoglobulin G
    • Palfi M., and Selbring A. 1998 Placental transport of maternal immunoglobulin G. Am J Reprod Immunol 39 (1998) 24-26
    • (1998) Am J Reprod Immunol , vol.39 , pp. 24-26
    • Palfi, M.1    Selbring, A.2
  • 16
    • 34547115206 scopus 로고    scopus 로고
    • Effects of a anti-TNFa monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system
    • Martin P.L., Oneda S., and Treacy G. Effects of a anti-TNFa monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system. Am J Reprod Immunol 58 (2007) 138-149
    • (2007) Am J Reprod Immunol , vol.58 , pp. 138-149
    • Martin, P.L.1    Oneda, S.2    Treacy, G.3
  • 17
    • 67650639673 scopus 로고    scopus 로고
    • ICHM3 M3(R1): Maintenance of the ICH guideline on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals issued as CPMP/ICH/286/95.
    • ICHM3 M3(R1): Maintenance of the ICH guideline on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals issued as CPMP/ICH/286/95.
  • 18
    • 33847188090 scopus 로고    scopus 로고
    • Luteinizing hormone-dependent activation of the epidermal growth factor network is essential for ovulation
    • Hsieh M., Lee D., Panigone S., Horner K., Chen R., Theologis A., et al. Luteinizing hormone-dependent activation of the epidermal growth factor network is essential for ovulation. Mol Cell Biol 27 (2007) 1914-1924
    • (2007) Mol Cell Biol , vol.27 , pp. 1914-1924
    • Hsieh, M.1    Lee, D.2    Panigone, S.3    Horner, K.4    Chen, R.5    Theologis, A.6
  • 19
    • 0029074587 scopus 로고
    • Epithelial immaturity and multiorgan failure in mice lacking epidermal growth factor receptor
    • Miettinen P.J., Berger J.J., Meneses J., Phung Y., Pederson R.A., Werb Z., et al. Epithelial immaturity and multiorgan failure in mice lacking epidermal growth factor receptor. Nature 36 (1995) 337-341
    • (1995) Nature , vol.36 , pp. 337-341
    • Miettinen, P.J.1    Berger, J.J.2    Meneses, J.3    Phung, Y.4    Pederson, R.A.5    Werb, Z.6
  • 20
    • 0029045856 scopus 로고
    • Strain-dependent epithelial defects in mice lacking the EGF receptor
    • Sibilia M., and Wagner E.F. Strain-dependent epithelial defects in mice lacking the EGF receptor. Science 269 (1995) 234-238
    • (1995) Science , vol.269 , pp. 234-238
    • Sibilia, M.1    Wagner, E.F.2
  • 21
    • 0029064203 scopus 로고
    • Targeted disruption of mouse EGF receptor: effect of genetic background on mutant phenotype
    • Threadgill D.W., Dlugosz A.A., Hansen L.A., Tennenbaum T., Lichti U., Yee D., et al. Targeted disruption of mouse EGF receptor: effect of genetic background on mutant phenotype. Science 269 (1995) 230-234
    • (1995) Science , vol.269 , pp. 230-234
    • Threadgill, D.W.1    Dlugosz, A.A.2    Hansen, L.A.3    Tennenbaum, T.4    Lichti, U.5    Yee, D.6
  • 22
    • 0038045775 scopus 로고    scopus 로고
    • Transfer of antibody via mother's milk
    • Van de Perre P. Transfer of antibody via mother's milk. Vaccine 21 (2007) 3374-3376
    • (2007) Vaccine , vol.21 , pp. 3374-3376
    • Van de Perre, P.1
  • 23
    • 1842579535 scopus 로고    scopus 로고
    • Potent thyrotrophin receptor-blocking antibodies: a cause of transient congenital hypothyroidism and delayed thyroid development
    • Evans C., Jordan N.J., Owens G., Bradley D., Ludgate M., and John R. Potent thyrotrophin receptor-blocking antibodies: a cause of transient congenital hypothyroidism and delayed thyroid development. Eur J Endocrinol 150 (2004) 265-268
    • (2004) Eur J Endocrinol , vol.150 , pp. 265-268
    • Evans, C.1    Jordan, N.J.2    Owens, G.3    Bradley, D.4    Ludgate, M.5    John, R.6
  • 24
    • 67650608829 scopus 로고    scopus 로고
    • Prenatal growth in cynomolgus and rhesus macaque (Macaca fascicularis and Macacca mulatto): a comparison by ultrasonography
    • Tarantal A.F., and Hendrickx A.G. Prenatal growth in cynomolgus and rhesus macaque (Macaca fascicularis and Macacca mulatto): a comparison by ultrasonography. J Med Primatol 17 (1998) 105-112
    • (1998) J Med Primatol , vol.17 , pp. 105-112
    • Tarantal, A.F.1    Hendrickx, A.G.2
  • 25
    • 34248561153 scopus 로고    scopus 로고
    • Use of barusiban in a novel study design for evaluation of tocolytic agents in pregnant and neonatal monkeys, including behavioural and immunological endpoints
    • Rasmussen A., Nelson J., Chellman G., Golub M., and McAnulty P. Use of barusiban in a novel study design for evaluation of tocolytic agents in pregnant and neonatal monkeys, including behavioural and immunological endpoints. Reprod Toxicol 23 (2007) 471-479
    • (2007) Reprod Toxicol , vol.23 , pp. 471-479
    • Rasmussen, A.1    Nelson, J.2    Chellman, G.3    Golub, M.4    McAnulty, P.5
  • 26
    • 0018826095 scopus 로고
    • Transfer of antirotaviral antibodies from mothers to their infants
    • McLean B., and Holmes I.H. Transfer of antirotaviral antibodies from mothers to their infants. J Clin Microbiol 12 (1980) 320-325
    • (1980) J Clin Microbiol , vol.12 , pp. 320-325
    • McLean, B.1    Holmes, I.H.2
  • 27
    • 0017087327 scopus 로고
    • Immunoglobulins A, G, and M in serum and in some secretions of monkeys (Macaca fascicularis)
    • Cole M.F., and Bowen W.H. Immunoglobulins A, G, and M in serum and in some secretions of monkeys (Macaca fascicularis). Infect Immun 13 (1976) 1354-1359
    • (1976) Infect Immun , vol.13 , pp. 1354-1359
    • Cole, M.F.1    Bowen, W.H.2
  • 28
    • 0023890311 scopus 로고
    • Age-related changes of immunoglobulin levels in African green monkeys (Cercopithecus aethiops)
    • Fujimoto K., Hiyaoka A., Cho F., and Honjo S. Age-related changes of immunoglobulin levels in African green monkeys (Cercopithecus aethiops). J Med Primatol 17 (1988) 85-93
    • (1988) J Med Primatol , vol.17 , pp. 85-93
    • Fujimoto, K.1    Hiyaoka, A.2    Cho, F.3    Honjo, S.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.