A critical evaluation of developmental and reproductive toxicology in nonhuman primates

References

• Aslam, H., Rosiepen, G., Krishnamurthy, H., Arslan, M., Clemen, G., (1999) The cycle duration of the seminiferous epithelium remains unaltered during GnRH antagonist induced testicular involution in rats and monkeys. J. Endocrinol 161:281–288
   PubMed Web of Science ®Google Scholar
• Brazelton, T.B. (1984) Neonatal behavioral assessment scale, 2nd edition. Lippincott, Philadelphia, PA, USA.
   Google Scholar
• Cappon, G.D., Grantham, L., Chmielewski, G., Bowman, C.J. and Hurtt, M.E. (2011) Power analysis of learning and memory data obtained in a non-human primate ePPND study. Birth defect research Part A: Clinical and Molecular Teratology 91(5): 361.
   Google Scholar
• Cavagnaro, J.A. (2002) Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Nat Rev Drug Discov 1: 469–475.
   PubMed Web of Science ®Google Scholar
• Chellman, G., Bussiere, J.L., Makori, N., Martin, P.L. Ooshima, Y. and Weinbauer, G. (2009) Developmental and reproductive toxicology studies in nonhuman primates. Birth Defects Res (Part B) 86:446–462.
   PubMed Web of Science ®Google Scholar
• De Rijk, E.P. and Van Esch, E. (2008) The Macaque Placenta—A Mini-Review. Toxicol Pathol 36:108S–118S.
   Web of Science ®Google Scholar
• Diabo, C., Kob, M., Cohle, C. and Faqi, A.S. (2012) Irregular Menstrual Cycling: A Logistical Hurdle to Successful Breeding of Cynomolgus Monkeys. Abstract accepted for presentation at Society of Toxicology, 2012
   Google Scholar
• Ehmcke J., Wistuba J. and Schlatt S. (2006) Spermatogonial stem cells: questions, models and perspectives. Human Reprod Update 12(3):275–282
   Google Scholar
• Fraser, H.M. and Lunn, S.F. (1999) Nonhuman primates and female reproductive medicine. In Reproduction in Nonhuman primates. ed. Weinabuaer, G.F. and Korte, R., Waxmann, Munster, Germany, pp 27–59.
   Google Scholar
• Hendrickx, A.G., Binkerd, P.E. and Rowland, J.M. (1983) Developmental toxicity and Nonhuman primates - Interspecies comparison. In Issues and Reviews in Teratology, Vol. 1. ed. Kalter, H., Plenum Press, London, UK, pp 149–180.
   Google Scholar
• Hummler, H., Korte, R. and Hendrickx, A.G. (1999) Induction of malformations in the cynomolgus monkey with 13-cis retinoic acid. Teratology 42(3): 263–272.
   Google Scholar
• ICH M3 (R2) (2008) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Draft Step 3 2008 www.ich.org
   Google Scholar
• ICH S5 (R2) (2005) Guidance on Reproductive Toxicology and Male Fertility: Detection of Toxicity to Reproduction for Medicinal Products 2005 www.ich.org
   Google Scholar
• ICH S6 (R1) (2009) Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 2009 www.ich.org
   Google Scholar
• Jarvis, P., Srivastav, S., Vogelwedde, E., Stewart, J., Mitchard, T. and Weinbauer, G. (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 (Part B) 89:175–187
   PubMedGoogle Scholar
• Malek, A., Sager, R., Kuhn, P., Nicholaides, K.H. and Schneider, H. (1996) Evaluation of maternofetal transport of immunoglobulins during human pregnancy. Am J Reprod Immunol 36:248–255.
   PubMed Web of Science ®Google Scholar
• Martin, P.L., Breslin,W., Rocca, M., Wright, D. and Cavagnaro, J. (2009) Considerations in Assessing the Developmental and Reproductive Toxicity Potential of Biopharmaceuticals. Birth Defects Res (Part B) 86:176–203.
   PubMedGoogle Scholar
• Meyer, J.K, Fitzsimmons, D., Hastings, T.F. and Chellman, G.J. (2006) Methods for the prediction of breeding success in male cynomolgus monkeys (Macaca fasciculararis) used for reproductive toxicology studies. J. Am. Assoc. Lab Animal Sci 45:31–36.
   PubMed Web of Science ®Google Scholar
• Pentsuk, N. and van der Laan, J.W. (2009) An interspecies comparison of placental antibody transfer: New insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res (Part B) 86:328–344.
   PubMed Web of Science ®Google Scholar
• Peterson, P.E., Short, J.J., Tarara, R., Valverde, C., Rothgarn, E. and Hendrickx, A.G. (1997) Frequency of spontaneous congenital defects in rhesus and cynomolgus macaques. J Med Primatol 6(5):267–75.
   Google Scholar
• Shimizu, K. (2008) Reproductive Hormones and the Ovarian Cycle in Macaques. J. Mamm Ova Res 25(3):122–126.
   Google Scholar
• Stewat (2009) Developmental toxicity testing of monoclonal antibodies: an enhanced pre-and postnatal development study design option. Repro Toxicol. 28(2):220–225.
   PubMed Web of Science ®Google Scholar
• Van Esch, E., Buse, E., Weinbauer, G.F. and Cline, J.M. The Macaque Endometrium, with Special Reference to the Cynomolgus Monkey (Macaca fascicularis). Toxicologic Pathology. 36:67S–100S, 2008
   Web of Science ®Google Scholar
• Weinbauer, G.F. Frings, W., Fuchs, A., Niehaus, M. and Osterburg, I. (2008a) Reproductive//developmental toxicity assessment of biopharmaceuticals in nonhuman primates. In Preclinical safety evaluation of biopharmaceuticals: A science-based approach to facilitating clinical trials. ed. Cavagnaro, J., John Wiley & Sons, Inc., Hoboken, NJ, USA
   Google Scholar
• Weinbauer, G.F., Niehoff, M., Niehaus, M., Srivastav, S.H., Fuchs, A., Van Esch, E., (2008b) Physiology and Endocrinology of the Ovarian Cycle in Macaques. Toxicol Pathol 36:7S–23S.
   PubMed Web of Science ®Google Scholar