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Volumn 93, Issue 4, 2011, Pages 324-333

The enhanced pre- and postnatal study for nonhuman primates: Update and perspectives

Author keywords

Cynomolgus monkeys; Enhanced pre and postnatal study; Nonhuman primates

Indexed keywords

CD20 ANTIGEN; FC RECEPTOR; FC RECEPTOR GAMMA RIIIB; FIGITUMAB; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; MONOCLONAL ANTIBODY; RITUXIMAB; UNCLASSIFIED DRUG;

EID: 84856270574     PISSN: 1542975X     EISSN: 15429768     Source Type: Journal    
DOI: 10.1002/bdrc.20220     Document Type: Review
Times cited : (31)

References (38)
  • 1
    • 70350212956 scopus 로고    scopus 로고
    • Developmental and peri-postnatal study in cynomolgus monkeys with belimumab, a monoclonal antibody directed against B-lymphocyte stimulator
    • Auyeung-Kim DJ, Devalaraja MN, Migone TS, Cai W, Chellman GJ. 2009. Developmental and peri-postnatal study in cynomolgus monkeys with belimumab, a monoclonal antibody directed against B-lymphocyte stimulator. Reprod Toxicol 28: 443-455.
    • (2009) Reprod Toxicol , vol.28 , pp. 443-455
    • Auyeung-Kim, D.J.1    Devalaraja, M.N.2    Migone, T.S.3    Cai, W.4    Chellman, G.J.5
  • 2
    • 77955867182 scopus 로고    scopus 로고
    • Embryo-fetal developmental toxicity of figitumumab, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in cynomolgus monkeys
    • Bowman CJ, Chmielewski G, Oneda S, Finco D, Boucher MA, Todd M. 2010. Embryo-fetal developmental toxicity of figitumumab, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in cynomolgus monkeys. Birth Defects Res B Dev Reprod Toxicol 89: 326-338.
    • (2010) Birth Defects Res B Dev Reprod Toxicol , vol.89 , pp. 326-338
    • Bowman, C.J.1    Chmielewski, G.2    Oneda, S.3    Finco, D.4    Boucher, M.A.5    Todd, M.6
  • 3
    • 42049095775 scopus 로고    scopus 로고
    • What's so special about the developing immune system?
    • Burns-Naas LA, Hastings KL, Ladics GS, et al. 2008. What's so special about the developing immune system? Int J Toxicol 27: 223-254.
    • (2008) Int J Toxicol , vol.27 , pp. 223-254
    • Burns-Naas, L.A.1    Hastings, K.L.2    Ladics, G.S.3
  • 4
    • 29044435648 scopus 로고    scopus 로고
    • Development of the immune system in the cynomolgus monkey: the appropriate model in human targeted toxicology?
    • Buse E. 2005. Development of the immune system in the cynomolgus monkey: the appropriate model in human targeted toxicology? J Immunotoxicol 1;2: 211-216.
    • (2005) J Immunotoxicol , vol.1 , Issue.2 , pp. 211-216
    • Buse, E.1
  • 5
    • 68849119066 scopus 로고    scopus 로고
    • Alternative strategies for toxicity testing of species-specific biopharmaceuticals
    • Bussiere JL, Martin P, Horner M, et al. 2009. Alternative strategies for toxicity testing of species-specific biopharmaceuticals. Int J Toxicol 28: 230-253.
    • (2009) Int J Toxicol , vol.28 , pp. 230-253
    • Bussiere, J.L.1    Martin, P.2    Horner, M.3
  • 8
    • 77953681386 scopus 로고    scopus 로고
    • Preclinical development of monoclonal antibodies: considerations for the use of non-human primates
    • Chapman K, Pullen N, Coney L, et al. 2009. Preclinical development of monoclonal antibodies: considerations for the use of non-human primates. MAbs 1: 505-516.
    • (2009) MAbs , vol.1 , pp. 505-516
    • Chapman, K.1    Pullen, N.2    Coney, L.3
  • 9
    • 33947587491 scopus 로고    scopus 로고
    • Preclinical safety testing of monoclonal antibodies: the significance of species relevance
    • Chapman K, Pullen N, Graham M, Ragan I. 2007. Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat Rev Drug Discov 6: 120-126.
    • (2007) Nat Rev Drug Discov , vol.6 , pp. 120-126
    • Chapman, K.1    Pullen, N.2    Graham, M.3    Ragan, I.4
  • 11
    • 84856295670 scopus 로고    scopus 로고
    • Council of Europe. 2007. Appendix A of the European convention for the protection 493 of vertebrate animals used for experimental and other scientific purposes (ETS 494 no. 123) - Guidelines for the accommodation and care of animals (article 5 of 495 the convention). Cons 2006;123, effective from July 15
    • Council of Europe. 2007. Appendix A of the European convention for the protection 493 of vertebrate animals used for experimental and other scientific purposes (ETS 494 no. 123) - Guidelines for the accommodation and care of animals (article 5 of 495 the convention). Cons 2006;123, effective from July 15, 2007.
    • (2007)
  • 12
    • 84856249340 scopus 로고    scopus 로고
    • Use of ultrasound in breeding management in a mauritian cynomolgus colony
    • Weinbauer, G.F., and Vogel, F., eds.), Waxmann Publisher, Muenster-New York-Munich-Berlin
    • Domaingue MC, Wong P. 2011. Use of ultrasound in breeding management in a mauritian cynomolgus colony. In: Future Trends in Primate Toxicology and Biotechnology (Weinbauer, G.F., and Vogel, F., eds.), Waxmann Publisher, Muenster-New York-Munich-Berlin, pp 57-64.
    • (2011) Future Trends in Primate Toxicology and Biotechnology , pp. 57-64
    • Domaingue, M.C.1    Wong, P.2
  • 13
    • 0022339659 scopus 로고
    • Studies of marginal zinc deprivation in rhesus monkeys: infant behavior
    • Golub MS, Gershwin ME, Hurley LS, et al. 1985. Studies of marginal zinc deprivation in rhesus monkeys: infant behavior. Am J Clin Nutr 42: 1229-1239.
    • (1985) Am J Clin Nutr , vol.42 , pp. 1229-1239
    • Golub, M.S.1    Gershwin, M.E.2    Hurley, L.S.3
  • 14
    • 0019542956 scopus 로고
    • Mother-infant interaction in rhesus monkeys treated clinically with delta-9-tetrahydrocannabinol
    • Golub MS, Sassenrath EN, Chapman LF. 1981. Mother-infant interaction in rhesus monkeys treated clinically with delta-9-tetrahydrocannabinol. Child Dev 52: 389-392.
    • (1981) Child Dev , vol.52 , pp. 389-392
    • Golub, M.S.1    Sassenrath, E.N.2    Chapman, L.F.3
  • 15
    • 0033945551 scopus 로고    scopus 로고
    • Nonhuman primates: their role in assessing developmental effects of immunomodulatory agents
    • Hendrickx AG, Makori N, Peterson P. 2000. Nonhuman primates: their role in assessing developmental effects of immunomodulatory agents. Hum Exp Toxicol 19: 219-225.
    • (2000) Hum Exp Toxicol , vol.19 , pp. 219-225
    • Hendrickx, A.G.1    Makori, N.2    Peterson, P.3
  • 16
    • 84856269618 scopus 로고    scopus 로고
    • ICH M3(R2). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Available at:.
    • ICH M3(R2). 2009. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Available at:.
    • (2009)
  • 17
    • 84856275856 scopus 로고    scopus 로고
    • ICH S5(R2). Detection of toxicity to reproduction for medicinal products & toxicity to male fertility. Available at:.
    • ICH S5(R2). 2000. Detection of toxicity to reproduction for medicinal products & toxicity to male fertility. Available at:.
    • (2000)
  • 18
    • 84856295673 scopus 로고    scopus 로고
    • ICH S6(R1). Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Available at:.
    • ICH S6(R1) 2011. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Available at:.
    • (2011)
  • 19
    • 77953605709 scopus 로고    scopus 로고
    • The cynomolgus monkey as a model for developmental toxicity studies: variability of pregnancy losses, statistical power estimates and group size considerations
    • Jarvis P, Srivastav S, Vogelwedde E, et al. 2010. The cynomolgus monkey as a model for developmental toxicity studies: variability of pregnancy losses, statistical power estimates and group size considerations. Birth Defects Res B Dev Reprod Toxicol 89: 175-187.
    • (2010) Birth Defects Res B Dev Reprod Toxicol , vol.89 , pp. 175-187
    • Jarvis, P.1    Srivastav, S.2    Vogelwedde, E.3
  • 20
    • 67649253050 scopus 로고    scopus 로고
    • Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals
    • Martin PL, Breslin W, Rocca M, et al. 2009. Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals. Birth Defects Res B Dev Reprod Toxicol 86: 176-203.
    • (2009) Birth Defects Res B Dev Reprod Toxicol , vol.86 , pp. 176-203
    • Martin, P.L.1    Breslin, W.2    Rocca, M.3
  • 21
    • 34547115206 scopus 로고    scopus 로고
    • Effects of an anti-TNF-alpha monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system
    • Martin PL, Oneda S, Treacy G. 2007. Effects of an anti-TNF-alpha monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system. Am J Reprod Immunol 58: 138-149.
    • (2007) Am J Reprod Immunol , vol.58 , pp. 138-149
    • Martin, P.L.1    Oneda, S.2    Treacy, G.3
  • 22
    • 78650883790 scopus 로고    scopus 로고
    • Developmental toxicity testing of biopharmaceuticals in nonhuman primates: previous experience and future directions
    • Martin PL, Weinbauer GF. 2010. Developmental toxicity testing of biopharmaceuticals in nonhuman primates: previous experience and future directions. Int J Toxicol 29: 552-568.
    • (2010) Int J Toxicol , vol.29 , pp. 552-568
    • Martin, P.L.1    Weinbauer, G.F.2
  • 23
    • 70049090959 scopus 로고    scopus 로고
    • An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies
    • Pentšuk N, van der Laan JW. 2009. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol 86: 328-344.
    • (2009) Birth Defects Res B Dev Reprod Toxicol , vol.86 , pp. 328-344
    • Pentšuk, N.1    van der Laan, J.W.2
  • 24
    • 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 AD, Nelson JK, Chellman GJ, et al. 2007. 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: 471-479.
    • (2007) Reprod Toxicol , vol.23 , pp. 471-479
    • Rasmussen, A.D.1    Nelson, J.K.2    Chellman, G.J.3
  • 25
    • 34548229364 scopus 로고    scopus 로고
    • FcRn: the neonatal Fc receptor comes of age
    • Roopenian DC, Akilesh S. 2007. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 7: 715-725.
    • (2007) Nat Rev Immunol , vol.7 , pp. 715-725
    • Roopenian, D.C.1    Akilesh, S.2
  • 26
    • 0038384134 scopus 로고    scopus 로고
    • Placental transport of immunoglobulin G
    • Simister NE. 2003. Placental transport of immunoglobulin G. Vaccine 21: 3365-3369.
    • (2003) Vaccine , vol.21 , pp. 3365-3369
    • Simister, N.E.1
  • 27
    • 34347097419 scopus 로고
    • Beobachtungen über den Sexualzyklus, die Gravidität und die Geburt bei Javamakaken
    • Spiegel A. 1930. Beobachtungen über den Sexualzyklus, die Gravidität und die Geburt bei Javamakaken. Arch Gynecol Obstet 142: 561-591.
    • (1930) Arch Gynecol Obstet , vol.142 , pp. 561-591
    • Spiegel, A.1
  • 28
    • 84856275858 scopus 로고    scopus 로고
    • Developmental/reproductive study design options for monoclonal antibodies
    • Weinbauer GF, Vogel F, editors. Münster: Waxmann Publisher.
    • Stewart J. 2008. Developmental/reproductive study design options for monoclonal antibodies. In: Weinbauer GF, Vogel F, editors. Critical contributions of primate models for biopharmaceutical drug development. Münster: Waxmann Publisher. pp. 101-112.
    • (2008) Critical contributions of primate models for biopharmaceutical drug development , pp. 101-112
    • Stewart, J.1
  • 29
    • 67650627735 scopus 로고    scopus 로고
    • Developmental toxicity testing of monoclonal antibodies: an enhanced pre and postnatal design option
    • Stewart J. 2009. Developmental toxicity testing of monoclonal antibodies: an enhanced pre and postnatal design option. Reprod Toxicol 28: 220-225.
    • (2009) Reprod Toxicol , vol.28 , pp. 220-225
    • Stewart, J.1
  • 30
    • 84882562093 scopus 로고    scopus 로고
    • Ultrasound imaging in rhesus (Macaca mulatta) and long-tailed (Macaca fascicularis) macaques: reproductive and research applications
    • Wolfe-Coote,editor. San Diego: Elsevier.
    • Tarantal AF. 2005. Ultrasound imaging in rhesus (Macaca mulatta) and long-tailed (Macaca fascicularis) macaques: reproductive and research applications. In: Wolfe-Coote, editor. The handbook of experimental animals: the laboratory primate. San Diego: Elsevier. pp. 317-349.
    • (2005) The handbook of experimental animals: the laboratory primate , pp. 317-349
    • Tarantal, A.F.1
  • 31
    • 0023692109 scopus 로고
    • Characterization of prenatal growth and development in the crab-eating macaque (Macaca fascicularis) by ultrasound
    • Tarantal AF, Hendrickx AG. 1988. Characterization of prenatal growth and development in the crab-eating macaque (Macaca fascicularis) by ultrasound. Anat Rec 222: 177-184.
    • (1988) Anat Rec , vol.222 , pp. 177-184
    • Tarantal, A.F.1    Hendrickx, A.G.2
  • 33
    • 84856249344 scopus 로고    scopus 로고
    • ICH S6 regulatory reproduction studies to support the use of monoclonal antibodies
    • Weinbauer GF, Vogel F, editors. Waxmann Publisher: Muenster, New York, Munich, Berlin.
    • van der Laan JW, Pentsuk N. 2011. ICH S6 regulatory reproduction studies to support the use of monoclonal antibodies. In: Weinbauer GF, Vogel F, editors. Future trends in primate toxicology and biotechnology. Waxmann Publisher: Muenster, New York, Munich, Berlin. pp. 143-162.
    • (2011) Future trends in primate toxicology and biotechnology , pp. 143-162
    • van der Laan, J.W.1    Pentsuk, N.2
  • 34
    • 84992665572 scopus 로고    scopus 로고
    • Summary comparisons of female reproductive system in human and the cynomolgus monkey
    • van Esch E, Cline JM, Buse E, et al. 2008. Summary comparisons of female reproductive system in human and the cynomolgus monkey. Toxicol Pathol 36: 171S-172S.
    • (2008) Toxicol Pathol , vol.36
    • van Esch, E.1    Cline, J.M.2    Buse, E.3
  • 35
    • 65549168791 scopus 로고    scopus 로고
    • Postnatal development in cynomolgus monkeys following prenatal exposure to natalizumab, an alpha4 integrin inhibitor
    • Wehner NG, Shopp G, Osterburg I, et al. 2009. Postnatal development in cynomolgus monkeys following prenatal exposure to natalizumab, an alpha4 integrin inhibitor. Birth Defects Res B Dev Reprod Toxicol 86: 144-156.
    • (2009) Birth Defects Res B Dev Reprod Toxicol , vol.86 , pp. 144-156
    • Wehner, N.G.1    Shopp, G.2    Osterburg, I.3
  • 37
    • 84856262252 scopus 로고    scopus 로고
    • Objective groups size determination for developmental toxicity studies in a nonhuman primate model (Macaca fascicularis)
    • Weinbauer GF, Vogel F, editors. Muenster, New York, Munich, Berlin: Waxmann Publisher.
    • Weinbauer GF, Jarvis P, Srivastav S, et al. 2011. Objective groups size determination for developmental toxicity studies in a nonhuman primate model (Macaca fascicularis). In: Weinbauer GF, Vogel F, editors. Future trends in primate toxicology and biotechnology. Muenster, New York, Munich, Berlin: Waxmann Publisher. pp. 81-94.
    • (2011) Future trends in primate toxicology and biotechnology , pp. 81-94
    • Weinbauer, G.F.1    Jarvis, P.2    Srivastav, S.3
  • 38
    • 84992650960 scopus 로고    scopus 로고
    • Physiology and endocrinology of the ovarian cycle in macaques
    • Weinbauer GF, Niehoff M, Niehaus M, et al. 2008b. Physiology and endocrinology of the ovarian cycle in macaques. Toxicol Pathol 36: 7S-23S.
    • (2008) Toxicol Pathol , vol.36
    • Weinbauer, G.F.1    Niehoff, M.2    Niehaus, M.3


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