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Goldilocks' Determination of What New In Vivo Data are "Just Right" for Different Common Drug Development Scenarios, Part 1.Maternal-placental insulin-like growth factor (IGF) signaling and its importance to normal embryo-fetal development.Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices.The placenta, transfer of immunoglobulins, and safety assessment of biopharmaceuticals in pregnancy.Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development.Morphologic, stereologic, and morphometric evaluation of the nervous system in young cynomolgus monkeys (Macaca fascicularis) following maternal administration of tanezumab, a monoclonal antibody to nerve growth factor.Estradiol-induced gene expression in largemouth bass (Micropterus salmoides).Induction of gene expression in sheepshead minnows (Cyprinodon variegatus) treated with 17beta-estradiol, diethylstilbestrol, or ethinylestradiol: the use of mRNA fingerprints as an indicator of gene regulation.Placental transfer of Fc-containing biopharmaceuticals across species, an industry survey analysis.Multiple responses in gene expression in fish treated with estrogen.Evaluation of a novel delayed-type hypersensitivity assay to Candida albicans in adult and neonatal rats.Vitellogenin mRNA regulation and plasma clearance in male sheepshead minnows, (Cyprinodon variegatus) after cessation of exposure to 17 beta-estradiol and p-nonylphenol.Effects of in utero exposure to finasteride on androgen-dependent reproductive development in the male rat.The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates.Placental transfer of (125)Iodinated humanized immunoglobulin G2Δa in the Sprague Dawley rat.Developmental toxicity assessment of tanezumab, an anti-nerve growth factor monoclonal antibody, in cynomolgus monkeys (Macaca fascicularis).Object discrimination reversal as a method to assess cognitive impairment in nonhuman primate enhanced pre- and postnatal developmental (ePPND) studies: statistical power analysis.Contrasting effects of estrogen on transthyretin and vitellogenin expression in males of the marine fish, Sparus aurata.Tissue distribution of anidulafungin in neonatal rats.Immunologic effects of chronic administration of tofacitinib, a Janus kinase inhibitor, in cynomolgus monkeys and rats - Comparison of juvenile and adult responses.Juvenile toxicity assessment of anidulafungin in rats: an example of navigating case-by-case study design through scientific and regulatory challenges.Decreased maternal and fetal cholesterol following maternal bococizumab (anti-PCSK9 monoclonal antibody) administration does not affect rat embryo-fetal development.Sensitivity of male reproductive endpoints in nonhuman primate toxicity studies: a statistical power analysis.Reproductive toxicity assessment of sunitinib, a multitargeted receptor tyrosine kinase inhibitor, in male and female rats.Developmental toxicity of lersivirine in rabbits when administered throughout organogenesis and when limited to sensitive windows of axial skeletal development.Developmental toxicity study of lersivirine in mice.Estrogen-induced vitellogenin mRNA and protein in sheepshead minnow (Cyprinodon variegatus)Induction of tyrosine hydroxylase by forskolin: modulation with ageComparative estrogenicity of estradiol, ethynyl estradiol and diethylstilbestrol in an in vivo, male sheepshead minnow (Cyprinodon variegatus), vitellogenin bioassayEmbryo-fetal distribution of a biopharmaceutical IgG2 during rat organogenesisEmbryo-fetal transfer of bevacizumab (Avastin) in the rat over the course of gestation and the impact of neonatal Fc receptor (FcRn) bindingApplying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals
P50
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P50
description
researcher
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wetenschapper
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name
C J Bowman
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C J Bowman
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type
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C J Bowman
@en
C J Bowman
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prefLabel
C J Bowman
@en
C J Bowman
@nl
P106
P31
P496
0000-0002-2425-2603