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Appendix B: Workshop on Potential Case Studies for Unraveling Endocrine-Related Low-Dose Toxicity
Pages 166-171

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From page 166...
... 1:30 Case Example 3: Bisphenol A and Female Reproductive Effects Moderators: Weihsueh Chiu, Katrina Waters, Karen Robinson Panelists:  Joseph Braun, Brown University  Daniel Doerge, U.S. Food and Drug Administration  Jodi Flaws, University of Illinois at Urbana-Champaign (via teleconference)
From page 167...
... Secondary outcomes: Indicators of male reproductive effects, including altered levels of endocrine or biochemical signaling molecules (fetal testosterone, fetal testis steroidogenic or cholesterologenic proteins, and insulin-like factor 3) , receptors, or mRNAs; and changes in cell proliferation.
From page 168...
... ; and changes in anogenital distance. Secondary outcomes: Indicators of male reproductive effects, including altered levels of endocrine or biochemical signaling molecules (fetal testosterone, fetal testis steroidogenic or cholesterologenic proteins, and insulin-like factor 3)
From page 169...
... Male nonhuman mammalian populations exposed to vehicle-only treatment in experimental Comparators studies or lower levels of TCDD in wildlife studies Primary outcomes: Male reproductive effects, including alterations in fertility; effects on sperm production, maturation, transport, morphology, or motility; malformations (hypospadias or cryptorchidism) or alterations in size, weight, morphology, histology, or function of male reproductive organs (testis, epididymis, seminal vesicle, prostate, vas deferens, or gubernaculum)
From page 170...
... ; altered age at puberty; adverse effects on lactation; premature reproductive senescence; female-associated Outcomes reproductive behaviors; and altered mammary gland development. Secondary outcomes: Indicators of female reproductive effects, including altered levels of endocrine or biochemical signaling molecules (androstenedione, dehydroepiandrosterone sulfate, estradiol, estrone, insulin-like growth factor-1, luteinizing hormone, sex hormone-binding globulin, and testosterone)
From page 171...
... b. In general, the primary outcomes are indicators of clinical effects that would be considered adverse whereas the secondary outcomes are considered surrogate measures (e.g., laboratory tests)


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