A Practical Approach, Second Edition=Ronald D. Ho.pdf

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IN VITRO METHODS FOR THE STUDY OF MECHANISMS OF DEVELOPMENTAL TOXICOLOGY 695255. Davis, W.L., Jacoby, B.H., Farmer, G.R., and Cooper, O.J., Changes in cytosolic calcium, blebformation, and cell death in neural crest cells treated with isotretinoin and 4-oxo-isotretinoin, J.Craniofac. Genet. Dev. Biol., 10, 295, 1990.256. Bonnefoi, M.S., Mitochondrial glutathione and methyl iodide-induced neurotoxicity in primary neuralcell cultures, Neuro. Toxicol., 13, 401, 1992.257. Flint, O.P. and Orton, T.C., An in vitro assay for teratogens with cultures of rat embryo midbrain andlimb bud cells, Toxicol. Appl. Pharmacol., 76, 383, 1984.258. Kistler, A. and <strong>Ho</strong>ward, W.B., Testing of retinoids for teratogenicity in vitro: use of micromass limbbud culture, Methods Enzymol., 190, 427, 1990.259. Kistler, A., Limb bud cell cultures for estimating the teratogenic potential of compounds. Validationof the test system with retinoids, Arch. Toxicol., 60, 403, 1987.260. Hansen, J.M., Carney, E.W., Harris, C., Altered differentiation in rat and rabbit limb bud micromasscultures by glutathione modulating agents, Free Radic. Biol. Med., 31, 1582, 2001261. Flint, O.P., Orton, T.C., and Ferguson, R.A., Differentiation of rat embryo cells in culture: responsefollowing acute maternal exposure to teratogens and non-teratogens, J. Appl. Toxicol., 4, 109, 1984.262. Roark, E.F. and Greer, K., Transforming growth factor-beta and bone morphogenetic protein-2 act bydistinct mechanisms to promote chick limb cartilage differentiation in vitro, Dev. Dyn., 200, 103, 1994.263. Lee, Y.S. and Chuong, C.M., Activation of protein kinase A is a pivotal step involved in both BMP-2- and cyclic AMP-induced chondrogenesis, J. Cell Physiol., 170, 153, 1997.264. Boskey, A.L., Paschalis, E.P., Binderman, I., and Doty, S.B., BMP-6 accelerates both chondrogenesisand mineral maturation in differentiating chick limb-bud mesenchymal cell cultures, J. Cell Biochem.,84, 509, 2002.265. Kruger, M., Mennerich, D., Fees, S., Schafer, R., Mundlos, S. and Braun T., Sonic hedgehog is asurvival factor for hypaxial muscles during mouse development, Development, 128, 743, 2001.266. Whittaker, S.G., Wroble, J.T., Silbernagel, S.M. and Faustman, E.M. Characterization of cytoskeletaland neuronal markers in micromass cultures of rat embryonic midbrain cells, Cell. Biol. Toxicol., 9,359,1993.© 2006 by Taylor & Francis Group, LLC
CHAPTER 17Statistical Analysis for Developmental andReproductive ToxicologistsJames J. ChenCONTENTSI. Introduction ........................................................................................................................697II. Analysis of Continuous Response Data ............................................................................699A. Litter-Based ANOVA Method ...................................................................................699B. Linear Mixed-Effects Models....................................................................................700C. Example-Fetal Body Weight Data.............................................................................700III.Analysis of Binary Response Data....................................................................................701A. Independent Binary Response Data ..........................................................................701B. Correlated Binary Response Data .............................................................................7031. Litter-Based ANOVA Method .............................................................................7032. Likelihood and Quasi-Likelihood <strong>Approach</strong>es ...................................................7033. Example — Hydroxyurea Data...........................................................................704IV. Analysis of Count Data .....................................................................................................705A. Likelihood and Quasi-likelihood Methods................................................................706B. Example .....................................................................................................................706V. Quantitative Risk Assessment and Benchmark Dose........................................................707A. Dose-Response Model and Benchmark Dose...........................................................707B. Example .....................................................................................................................709VI. Discussion ..........................................................................................................................709References ......................................................................................................................................710I. INTRODUCTIONReproductive and developmental toxicity experiments are conducted in laboratory animals for theevaluation of potential adverse effects of chemical compounds on fertility, reproduction, and fetaldevelopment. Depending on the study design, a test compound is administered to either parentprior to conception, to the female during gestation, or postnatally. Various reproductive and developmentalendpoints are measured, recorded, and analyzed. These endpoints can be divided intotwo categories: (1) parental and (2) embryonic or fetal endpoints. Parental endpoints used to assessreproductive effects include: body weight and weight gain, mating index, fertility index, changes697© 2006 by Taylor & Francis Group, LLC
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Second EditionDEVELOPMENTALandREPRO
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Published in 2006 byCRC PressTaylor
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Chapter 12Chapter 13Chapter 14Chapt
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The EditorRonald D. Hood, Ph.D., is
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Alan M. HobermanArgus ResearchHorsh
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APPENDIX ATerminology of Anatomical
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TERMINOLOGY OF ANATOMICAL DEFECTS 9
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Organ/StructureCodeNumberObservatio
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Organ/Structure10145 Ocular colobom
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Organ/StructurePulmonaryarteryPulmo
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Terminology of developmental abnorm
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Organ/StructureCervicalcentrumCodeN
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Organ/Structure10689 Misshapen thor
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Organ/StructureSacralcentrumSacralv
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968 DEVELOPMENTAL REPRODUCTIVE TOXI
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1000 DEVELOPMENTAL REPRODUCTIVE TOX
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Table 1Human Non-human Primate Rat
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Table 1 (continued)Sertoli CellsHum
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Table 2 (continued) Landmarks in th
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Table 2 (continued) Landmarks in th
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POSTNATAL DEVELOPMENTAL MILESTONES
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PART IPrinciples and Mechanisms© 2
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4 DEVELOPMENTAL REPRODUCTIVE TOXICO
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10 DEVELOPMENTAL REPRODUCTIVE TOXIC
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Table 2.6Receptor(Official Name a )
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Clearly, more research needs to be
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CHAPTER 6Comparative Features of Ve
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COMPARATIVE FEATURES OF VERTEBRATE
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Table 6.2Comparative reproductive a
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Maturation andRelease ofGametesSper
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Amniotic cavity 9.5 1.5 1-4 1-4,6,9
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Posteriorcardinal veinsestablishedT
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PosteriorcardinaldegenerationRight
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StomachappearsThirdpharyngealpouch;
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Table 6.6DescriptionComparative ges
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ParathyroidParathyroids 12.5 6.2 41
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Table 6.8DescriptionComparative ges
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Formation ofchoroid plexusof latera
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Optic nervefibers presentDifferenti
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Table 6.10DescriptionMuscular Syste
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Distalphalanges offingersseparatedF
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Table 6.11DescriptionIntermediateme
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Table 6.12DescriptionComparative ge
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CHAPTER 7Developmental Toxicity Tes
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DEVELOPMENTAL TOXICITY TESTING —
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Female 0.00-0.69 0.004-0.39 0.00-0.
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Figure 8.11775Pott DescribesScrotal
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The underlying physiology of juveni
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Table 8.5Total body composition by
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Table 8.6Serum chemistry values for
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Table 8.7Parameter bHematology valu
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CHAPTER 9Significance, Reliability,
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DEVELOPMENTAL AND REPRODUCTIVE TOXI
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Prior to the early 1980s, numerous
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Figure 9.51906Food andDrugs Act2000
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Table 9.18Selected comparison point
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Table 9.33Selected comparison point
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Table 9.48What do regulatorswant to
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CHAPTER 10Testing for Reproductive
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TESTING FOR REPRODUCTIVE TOXICITY 4
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We would like to acknowledge the ef
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CHAPTER 12Role of Xenobiotic Metabo
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ROLE OF XENOBIOTIC METABOLISM IN DE
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y ESR spectrometry. 122 Further ESR
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CHAPTER 13Use of Toxicokinetics in
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USE OF TOXICOKINETICS IN DEVELOPMEN
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PERSPECTIVES ON THE DEVELOPMENTAL A
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Guideline OECD 415 (One Generation)
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The Office of Prevention, Pesticide
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CHAPTER 20Human Studies — Epidemi
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HUMAN STUDIES 801I. INTRODUCTIONEpi
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HUMAN STUDIES 803is actively trying
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HUMAN STUDIES 805100908070Induced a
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HUMAN STUDIES 813A distinction is s
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HUMAN STUDIES 829B. The Formation o
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HUMAN STUDIES 837with spina bifida
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CHAPTER 21Developmental and Reprodu
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There are six factors that may affe
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