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Birth Defects Research. Part B, Developmental and Reproductive Toxicology

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https://www.readbyqxmd.com/read/27792858/exposure-to-high-concentration-oxygen-in-the-neonatal-period-induces-abnormal-retinal-vascular-patterning-in-mice
#1
Akane Morita, Hiroko Ushikubo, Asami Mori, Kenji Sakamoto, Tsutomu Nakahara
The interruption of vascular development could cause structural and functional abnormalities in tissues. We have previously reported that short-term treatment of newborn mice with vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitors induces abnormal retinal vascular growth and patterns. An exposure of neonatal mice to high-concentration oxygen disturbs normal retinal vascular development. The present study aimed to determine (1) whether vascular abnormalities are observed in the retina of newborn mice exposed to high concentrations of oxygen, and (2) how astrocyte network formation is affected following the exposure to hyperoxia...
October 28, 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27669115/effect-of-fructose-on-the-phosphorylation-of-amp-activated-protein-kinase-and-acetyl-coa-carboxylase-in-hepg2-cells-stimulated-with-placental-lactogen
#2
Yuuka Mukai, Fumika Hoshi, Shin Sato
BACKGROUND: High fructose intake induces disruption of lipid metabolism via AMP-activated protein kinase (AMPK) signaling in the liver and peripheral tissues. Maternal lipid metabolism is physiologically altered by the activity of pregnancy hormones such as human placental lactogen (PL). To elucidate the influence of high fructose intake on hepatic lipid metabolism during pregnancy, we examined the effects of fructose on lipid metabolism via the AMPK pathway in hepatocytes stimulated with PL...
August 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27643382/reproductive-and-neurobehavioral-effects-of-maternal-exposure-to-piperonyl-butoxide-pbo-in-f1-generation-mice
#3
Toyohito Tanaka, Akiko Inomata
Female mice were exposed maternally to piperonyl butoxide (PBO) through diet to provide levels of 0 (control), 0.015, 0.03, and 0.06% during gestation and lactation periods, and selected reproductive and neurobehavioral parameters were measured in F1 generation. There was no adverse effect of PBO on litter size, litter weight, or sex ratio at birth. The average body weights of offspring showed no significant effects of PBO treatment through the lactation period in both sexes except for the low-dose group of females on PND 21...
August 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27601206/goldilocks-determination-of-what-new-in-vivo-data-are-just-right-for-different-common-drug-development-scenarios-part-1
#4
Christopher J Bowman, Robert E Chapin
As alternative models and scientific advancements improve the ability to predict developmental toxicity, the challenge is how to best use this information to support safe use of pharmaceuticals in humans. While in vivo experimental data are often expected, there are other important considerations that drive the impact of developmental toxicity data to human risk assessment and product labeling. These considerations include three key elements: (1) the drug's likelihood of producing off-target toxicities, (2) risk tolerance of adverse effects based on indication and patient population, and (3) how much is known about the effects of modulating the target in pregnancy and developmental biology...
August 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27519584/tgf-%C3%AE-1-monoclonal-antibody-assessment-of-embryo-fetal-toxicity-in-rats-and-rabbits
#5
Kim G Hilbish, Jennifer A Martin, Anja J Stauber, Tammye L Edwards, William J Breslin
A humanized monoclonal antibody targeting transforming growth factor β1 (TGF-β1 mab) has been used in development for the treatment of chronic kidney disease. Embryo-fetal development studies were conducted in rats and rabbits using 30 and 25 animals per group, respectively. The TGF-β1 mab was administered subcutaneously to rats at 0, 2, or 50 mg/kg/dose on gestation days (GDs) 6, 10, and 14 and intravenously to rabbits at 0 or 3 mg/kg/dose on GDs 7, 12 to 19, and at 30 mg/kg/dose on GDs 7, 12, 14, 16, and 18...
August 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27295407/ovarian-stimulators-intrauterine-insemination-and-assisted-reproductive-technologies-use-and-the-risk-of-major-congenital-malformations-the-atrisk-study
#6
Sonia Chaabane, Odile Sheehy, Patricia Monnier, François Bissonnette, Jacquetta M Trasler, William Fraser, Anick Bérard
OBJECTIVE: To quantify the risk of major congenital malformations (MCMs) associated with the use of ovarian stimulators alone, intrauterine insemination (IUI), and assisted reproductive technologies (ARTs). METHODS: We conducted a case-control analysis using a birth cohort, built with the linkage of data obtained by a self-administered questionnaire, medical, pharmaceutic, and birth databases. Cases were pregnancies with at least one live birth with an MCM. Controls were pregnancies that did not result in major or minor congenital malformations...
June 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27286044/gestational-and-early-postnatal-exposure-to-an-environmentally-relevant-mixture-of-brominated-flame-retardants-general-toxicity-and-skeletal-variations
#7
Emily W Y Tung, Han Yan, Pavine L C Lefèvre, Robert G Berger, Dorothea F K Rawn, Dean W Gaertner, Alice Kawata, Marc Rigden, Bernard Robaire, Barbara F Hales, Michael G Wade
Brominated flame retardants (BFRs) are stable environmental contaminants known to exert endocrine-disrupting effects. Developmental exposure to polybrominated diphenyl ethers (PBDEs) is correlated with impaired thyroid hormone signaling, as well as estrogenic and anti-androgenic effects. As previous studies have focused on a single congener or technical mixture, the purpose of the current study was to examine the effects of gestational and early postnatal exposure to an environmentally relevant mixture of BFRs designed to reflect house dust levels of PBDEs and hexabromocyclododecane on postnatal developmental outcomes...
June 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27221585/preclinical-reproductive-and-developmental-toxicity-profile-of-a-glycine-transporter-type-1-glyt1-inhibitor
#8
Paul Barrow, Neil Parrott, Daniela Alberati, Axel Paehler, Annette Koerner
Bitopertin is a glycine type 1 (GlyT1) inhibitor intended for the treatment of psychiatric disorders. The principle adverse effect in the regulatory reproductive toxicity studies was peri-natal pup death when rat dams were treated during parturition at a dose resulting in five-times the human therapeutic exposure (AUC). Cessation of dosing two days before parturition prevented the pup deaths. Investigatory experiments and pharmacokinetic modelling suggested that the neonatal mortality was related to transplacental passage of bitopertin leading to high systemic levels in the newborn pups...
June 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27175943/retinoic-acid-and-pitx2-regulate-early-neural-crest-survival-and-migration-in-craniofacial-and-ocular-development
#9
Bahaar Chawla, Elisa Schley, Antionette L Williams, Brenda L Bohnsack
No abstract text is available yet for this article.
June 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27074409/developmental-toxicity-studies-with-pregabalin-in-rats-significance-of-alterations-in-skull-bone-morphology
#10
Dennis C Morse, Judith W Henck, Steven A Bailey
Pregabalin was administered to pregnant Wistar rats during organogenesis to evaluate potential developmental toxicity. In an embryo-fetal development study, compared with controls, fetuses from pregabalin-treated rats exhibited increased incidence of jugal fused to maxilla (pregabalin 1250 and 2500 mg/kg) and fusion of the nasal sutures (pregabalin 2500 mg/kg). The alterations in skull development occurred in the presence of maternal toxicity (reduced body weight gain) and developmental toxicity (reduced fetal body weight and increased skeletal variations), and were initially classified as malformations...
April 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27062127/an-evaluation-of-the-impact-of-pd-1-pathway-blockade-on-reproductive-safety-of-therapeutic-pd-1-inhibitors
#11
REVIEW
Frederique M Poulet, Jayanthi J Wolf, Danuta J Herzyk, Joseph J DeGeorge
This report discusses the principles of reproductive toxicity risk assessment for biopharmaceuticals blocking the PD-1/programmed cell death ligand 1 (PD-L1) pathway, which have been developed for the treatment of patients with advanced malignancies. The PD-1/PD-L1 pathway is a T-cell co-inhibitory pathway that normally maintains immune tolerance to self. Its role in pregnancy is to maintain immune tolerance to the fetal allograft. In cancer patients, this signaling pathway is hijacked by some neoplasms to avoid immune destruction...
April 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27044003/embryo-fetal-developmental-toxicity-studies-with-pregabalin-in-mice-and-rabbits
#12
Dennis C Morse
Pregabalin was evaluated for potential developmental toxicity in mice and rabbits. Pregabalin was administered once daily by oral gavage to female albino mice (500, 1250, or 2500 mg/kg) and New Zealand White rabbits (250, 500, or 1250 mg/kg) during organogenesis (gestation day 6 through 15 [mice] or 6 through 20 [rabbits]). Fetuses were evaluated for viability, growth, and morphological development. Pregabalin administration to mice did not induce maternal or developmental toxicity at doses up to 2500 mg/kg, which was associated with a maternal plasma exposure (AUC0-24 ) of 3790 μg•hr/ml, ≥30 times the expected human exposure at the maximum recommended daily dose (MRD; 600 mg/day)...
April 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/27038066/a-probability-analysis-of-historical-pregnancy-and-fetal-data-from-dutch-belted-and-new-zealand-white-rabbit-strains-from-embryo-fetal-development-studies
#13
Lorraine M Posobiec, Estella M Cox, Howard M Solomon, Elise M Lewis, Kai-fen Wang, Dinesh Stanislaus
Embryo-fetal development (EFD) studies, typically in pregnant rats and rabbits, are conducted prior to enrolling females of reproductive age in clinical trials. Common rabbit strains used are the New Zealand White (NZW) and Dutch Belted (DB). As fetal abnormalities can occur in all groups, including controls, Historical Control Data (HCD) is compiled using data from control groups of EFD studies, and is used along with each study's concurrent control group to help determine whether fetal abnormalities are caused by the test article or are part of background incidences...
April 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/26865470/mechanism-of-developmental-effects-in-rats-caused-by-an-n-phenylimide-herbicide-transient-fetal-anemia-and-sequelae-during-mid-to-late-gestation
#14
Satoshi Kawamura, Takafumi Yoshioka, Nobuaki Mito, Noriyuki Kishimoto, Masanao Nakaoka, Alan G Fantel
BACKGROUND: Rat developmental toxicity including embryolethality and teratogenicity (mainly ventricular septal defects [VSDs] and wavy ribs) was produced by an N-phenylimide herbicide that inhibits protoporphyrinogen oxidase (PPO) common to chlorophyll and heme biosynthesis. Major characteristics of the developmental toxicity included species difference between rats and rabbits, compound-specific difference among structurally similar herbicides, and sensitive period. Protoporphyrin accumulation in treated fetuses closely correlated with the major characteristics...
February 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/26848810/numeric-estimates-of-teratogenic-severity-from-embryo-fetal-developmental-toxicity-studies
#15
L David Wise
A developing organism exposed to a toxicant will have a response that ranges from none to severe (i.e., death or malformation). The response at a given dosage may be termed teratogenic (or developmental toxic) severity and is dependent on exposure conditions. Prenatal/embryo-fetal developmental (EFD) toxicity studies in rodents and rabbits are the most consistent and definitive assessments of teratogenic severity, and teratogenesis screening assays are best validated against their results. A formula is presented that estimates teratogenic severity for each group, including control, within an EFD study...
February 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/26762583/investigation-on-toxicity-and-teratogenicity-in-rats-of-a-retinoid-polyamine-conjugate-with-potent-anti-inflammatory-properties
#16
Theodoros Petridis, Dimitra Giannakopoulou, Vassiliki Stamatopoulou, Katerina Grafanaki, Christos G Kostopoulos, Helen Papadaki, Christina J Malavaki, Nikos K Karamanos, Stathianna Douroumi, Dionysios Papachristou, George E Magoulas, Dionissios Papaioannou, Denis Drainas
Previous studies have shown that N(1),N(12)-bis(all-trans-retinoyl)spermine (RASP), a retinoid analog, inhibits RNase P activity and angiogenesis in the chicken embryo chorioallantoic membrane, demonstrates anti-tumor activity on prostate cancer cells, and acts as anti-inflammatory agent, being more effective and less toxic than all-trans retinoic acid. In an attempt to further characterize the biological profile of RASP, we tested its effects on organ toxicity and teratogenicity by daily oral gavage of RASP at a level of 50 mg/Kg of body weight in two generations of rats...
February 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/26748987/diabetes-in-the-cohen-rat-intensifies-the-fetal-pancreatic-damage-induced-by-the-diabetogenic-high-sucrose-low-copper-diet
#17
Zivanit Ergaz, Meytal Neeman-Azulay, Liza Weinstein-Fudim, Sarah Weksler-Zangen, Dana Shoshani-Dror, Moshe Szyf, Asher Ornoy
Intrauterine hyperglycemic environment could harm the fetus making it more susceptible to develop postnatal glucose intolerance. A possible mechanism is compromise of the fetal pancreatic development. We previously found that a high sucrose low copper diabetogenic diet induces type 2 diabetes in the Cohen diabetic sensitive rats, but not in the Sabra control rats. However, oxidative stress was observed in the placenta and term fetal liver of diabetic and nondiabetic controls. We now investigated whether the fetal pancreas is affected by this diet and whether the effects result from oxidative stress, maternal hyperglycemia, or both...
February 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/26729651/a-developmental-toxicology-assay-platform-for-screening-teratogenic-liability-of-pharmaceutical-compounds
#18
Karen Augustine-Rauch, Cindy X Zhang, Julieta M Panzica-Kelly
Increasing need for proactive safety optimization of pharmaceutical compounds has led to generation and/or refinement of in vitro developmental toxicology assays. Our laboratory has developed three in vitro developmental toxicology assays to assess teratogenic liability of pharmaceutical compounds. These assays included a mouse molecular embryonic stem cell assay (MESCA), a dechorionated zebrafish embryo culture (ZEC) assay, and a streamlined rat whole embryo culture (rWEC) assay. Individually, the assays presented good (73-82%) predictivity...
February 2016: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/26663788/advanced-paternal-age-and-risk-of-musculoskeletal-congenital-anomalies-in-offspring
#19
Stine Kjaer Urhoj, Laust Hvas Mortensen, Anne-Marie Nybo Andersen
OBJECTIVE: Previous research suggests that advanced paternal age increases the risk of musculoskeletal congenital anomalies (CAs) in offspring, but findings are inconsistent. This study aims to investigate the risk of musculoskeletal CAs according to paternal age at birth in an unselected population covering cohort of children. STUDY DESIGN: A register-based prospective study of 1,605,885 children born in Denmark, 1978-2004, using information from record-linked health and administrative registers...
December 2015: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
https://www.readbyqxmd.com/read/26663754/visualizing-compound-distribution-during-zebrafish-embryo-development-the-effects-of-lipophilicity-and-dmso
#20
Coco de Koning, Manon Beekhuijzen, Marysia Tobor-Kapłon, Selinda de Vries-Buitenweg, Dick Schoutsen, Nico Leeijen, Beppy van de Waart, Harry Emmen
The predictability of the zebrafish embryo model is highly influenced by internal exposure of the embryo/larva. As compound uptake is likely to be influenced by factors such as lipophilicity, solvent use, and chorion presence, this article focuses on investigating their effects on compound distribution within the zebrafish embryo. To visualize compound uptake and distribution, zebrafish embryos were exposed for 96 hr, starting at 4 hr postfertilization, to water-soluble dyes: Schiff's reagent (logP -4.63), Giemsa stain (logP -0...
December 2015: Birth Defects Research. Part B, Developmental and Reproductive Toxicology
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