Developmental and Reproductive Toxicology

Pharmaceutical Toxicology in Practice: A Guide for Non-Clinical Development

Volumn , Issue , 2011, Pages 165-198

  Stadler, Jeanne ^a  

^a EURL Jeanne STADLER   (France)

Author keywords

Conduct of studies, test compound plan integrated with clinical study plan; Developmental and reproductive toxicology; Developmental toxicology, teratology structural malformations, and deviations in organisms

Indexed keywords

EID: 84885990842     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470909911.ch9     Document Type: Chapter

References (50)

1. Encyclopædia Britannica, 2009. Life cycle. http://www.britannica.com/EBchecked/topic/ 340084/life-cycle
2. Colborn T, vom Saal FS, and Soto AM, 1993. Developmental effects of endocrine-disrupting chemicals in wildlife and humans. Environ Health Perspect 101:378-384
3. Guo YL, Lambert GH, and Hsu CC, 1995. Growth abnormalities in the population exposed in utero and early postnatally to polychlorinated biphenyls and dibenzofurans. Environ Health Perspect 103:117-122
4. Szabo DT, Bigsby R, Chapin RE et al., 1999. Evaluating the effects of endocrine disruptors on endocrine function during development. Environ Health Perspect 107:613-8 196 DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY
5. Castro DJ, Löhr CV, Fischer KA, Pereira CB, and Williams DE., 2008. Lymphoma and lung cancer in offspring born to pregnant mice dosed with dibenzo[a,l]pyrene: The importance of in utero vs. lactational exposure. Toxicol Appl Pharmacol 233:454-458
6. Eriksson P, Lundkvist U, and Fredriksson A, 1991. Neonatal exposure to 3,3',4,4'- tetrachlorobiphenyl: hanges in spontaneous behaviour and cholinergic muscarinic receptors in the adult mouse. Toxicology 69:27-34
7. Recabarren SE, Rojas-Garćia PP, Recabarren MP et al., 2008. Prenatal testosterone excess reduces sperm count and motility. Endocrinology 149:6444-6448
8. Richardson VM, Ross DG, Diliberto JJ et al., 2009. Effects of perinatal PBDE exposure on hepatic phase I, phase II, phase III, and deiodinase 1 gene expression involved in thyroid hormone metabolism in male rat pups. Toxicol Sci 107:27-39
9. Lilienthal H, Hack A, Roth-Härer A et al., 2006. Effects of developmental exposure to 2,2,4,4,5-pentabromodiphenyl ether (PBDE-99) on sex steroids, sexual development, and sexually dimorphic behavior in rats. Environ Health Perspect 114:194-201
10. Talsness CE, Shakibaei M, Kuriyama S et al., 2005. Ultrastructural changes observed in rat ovaries following in utero and lactational exposure to low doses of a polybrominated flame retardant. Toxicol Lett 157:189-202
11. Eriksson P, Viberg H, Jakobsson E et al., 2002. A brominated flame retardant, 2,2',4,4',5- pentabromodiphenyl ether: uptake, retention, and induction of neurobehavioral alterations in mice during a critical phase of neonatal brain development. Toxicol Sci 67:98-103
12. Viberg H, Johansson N, Fredriksson A et al., 2006. Neonatal exposure to higher brominated diphenyl ethers, hepta-, octa-, or nonabromodiphenyl ether, impairs spontaneous behavior and learning and memory functions of adult mice. Toxicol Sci 92:211-218
13. Herbst AL, Ulfelder H and Poskanzer DC, 1971. Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med 284:878-881
14. Hatch EE, Palmer JR, Titus-Ernstoff L et al., 1998. Cancer risk in women exposed to diethylstilbestrol in utero. JAMA 280:630-634
15. Klip, H, J. Verloop et al., 2002. Hypospadias in sons of women exposed to diethylstilbestrol in utero: A cohort study. The Lancet 359:1081-1082
16. Brouwers, MM, Feitz WF et al., 2006. Hypospadias: A transgenerational effect of diethylstilbestrol? Hum Reprod 21:666-669
17. Wilson JG, 1959. Experimental studies on congenital malformations. JChron Dis 10:111-130.
18. International Conference on Hybridization, 2005. S5(R2) guideline. Detection of toxicity to reproduction for medicinal products & toxicity to male fertility. http://www.ich.org/LOB/ media/MEDIA498.pdf
19. U.S. Food and Drug Administration, 2006. Guidance for industry: nonclinical safety evaluation of pediatric drug products. http://www.fda.gov/cder/guidance/5671fnl.html
20. European Medicines Agency, 2005a. Draft guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications. http://www.ema. europa.eu/pdfs/human/swp/16921505en08.pdf
21. Barrow P, 1990. Technical Procedures in Reproduction Toxicology. Laboratory Animals Handbooks 11. London: Royal Society of Medicine.
22. Baldrick P., 2004. Developing drugs for pediatric use: a role for juvenile animal studies? Regul Toxicol Pharmacol 39:381-389
23. Hurtt ME, 2004. Workshop Summary Juvenile animal studies: Testing strategies and design. Birth Defects Res B: Dev Reprod Toxicol 71:281-288
24. ICH, 2000. E11 guideline: Clinical investigation of medicinal products in the pediatric population. http://www.ich.org/LOB/media/MEDIA487.pdf
25. Stahlmann R, Chahoud I, Meister R, et al., 1988. Gentamicin plasma concentrations in pregnant and nonpregnant rats and fetuses after single and multiple injections. Arch Toxicol 62:232-235
26. McElhatton PR, Sullivan FM and Toseland PA, 1997. The metabolism of primidone in nonpregnant and 14-day pregnant mice. Xenobiotica 7:611-615
27. Mercier O, Perraud J, Stadler J, and Kessedjian MJ, 1985. A standardized method to test the copulatory behaviour of male rats: A basis of evaluation of drug effects. Teratology 32:28A
28. Mercier O, Perraud J, and Stadler J, 1987. A method for the routine observation of sexual behaviour in rats. Lab Animals 21:125-130
29. Wilson, JG, 1965. Methods for administering agents and detecting malformations in experimental animals. In: J.G. Wilson and J. Warkany, editors, Teratology, Principles and Techniques. Chicago and London: The University of Chicago Press. Pp. 262-277
30. Dawson, AB, 1926. A note of the staining of the skeleton of cleared specimens with alizarin red S. Stain Technol 1:123-124
31. Zieske JD, 2004. Corneal development associated with eyelid opening. Int J Dev Biol 48:903-911
32. Calamandrei G, 2004. Ethological and methodological considerations in the use of newborn rodents in biomedical research. Ann Ist Super Sanita 40:195-200
33. Pedersen PE, Stewart WB, Greer CA, Shepherd GM, 1983. Evidence for olfactory function in utero. Science 221:478-480
34. Amsel A, Burdette DR, and Letz R, 1976. Appetitive learning, patterned alternation, and extinction in 10-d-old rats with non-lactating suckling as reward. Nature 262:816-818
35. Bourdois PS, Junghani J, Perraud J, and Reinert H, 1975. Transplacental effects of drugs on hearing, vision and behaviour. Poster 87. 14th Meeting of the Society of Toxicology, Williamsburg.
36. Prusky GT, Silver BD Tschetter WW et al., 2008. Experience-dependent plasticity from eye opening enables lasting, visual cortex dependent enhancement of motion vision. J Neurosci 28: 9817-9827
37. Prusky GT, Alam NM, Beekman S, and Douglas RM, 2004. Rapid quantification of adult and developing mouse spatial vision using a virtual optomotor system. Invest Ophthalmol Vis Sci 45:4611-4616
38. Douglas RM, Alam NM, Silver BD et al., 2005. Independent visual threshold measurements in the two eyes of freely moving rats and mice using a virtual-reality optokinetic system. Vis Neurosci 22:677-684
39. Sokolic L, Laing DG, and McGregor IS, 2007. Asymmetric suppression of components in binary aldehyde mixtures: behavioral studies in the laboratory rat. Chem Senses 32:191- 199
40. Vorhees CV, Reed TM, Acuff-Smith KD et al., 1995. Long-term learning deficits and changes in unlearned behaviors following in utero exposure to multiple daily doses of cocaine during different exposure periods and maternal plasma cocaine concentrations. Neurotoxicol Teratol 17:253-264
41. Zoetis T and HurttM, 2003. Species comparison of lung development. Birth Defects Res Part B: Dev Reprod Toxicol 68:121-124
42. Chevalier G, Forster R, and Bouchez C, 2009. Evaluation of the feasibility of juvenile toxicity study in the Göttingen Minipig. Toxicol Lett 189:S144
43. Diehl KH, Hull R, Morton D, Pfister R et al., 2001. A good practice guide to the administration of substances and removal of blood, including routes and volumes, J Appl Toxicol 21:15-23
44. Beck MJ, Padgett EL, Bowman CJ et al., 2006. Nonclinical juvenile toxicity testing. In: RD Hood, editor. Developmental and Reproductive Toxicology: A Practical Approach, 2nd ed. Boca Raton, FL: CRC Press. pp. 263-328
45. Barrow P, 2007. Toxicology testing for products intended for pediatric populations. In: WK Sietsema and R Schwen, editors. Nonclinical drug safety assessment: practical considerations for successful registration. Washington DC: FDA News. pp. 411-440
46. Makris SL, Solomon HM, Clark, C., et al., 2009. Terminology of developmental abnormalities in common laboratory mammals (version 2). Birth Defects Res B 86:227-327
47. Chahoud, I. Buschmann J, Clark, C., R et al., 1999. Classification terms in developmental toxicology: need for harmonisation. Reprod Toxicol 13:77-82
48. Solecki R, Bergmann B, Bürgin H et al., 2003. Conference [roceedings: Harmonization of rat fetal external and visceral terminology and classification. Report of the Fourth Workshop on the Terminology in Developmental Toxicology, Berlin, 18-20 April 2002. Reprod Toxicol 17:625-637
49. U.S. Food and Drug Administration, 2001. Draft reviewer guidance integration of study results to assess concerns about human reproductive and developmental toxicities. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079240.pdf
50. European Medicines Agency, 2008. EMEA/CHMP/203927/2005. Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labeling. http://www.ema.europa.eu/pdfs/human/swp/20392705enfin.pdf