Birth Defects Research Part B: Developmental and Reproductive Toxicology This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Exposure to High ‐Concentration Oxygen in the Neonatal Period Induces Abnormal Retinal Vascular Patterning in Mice
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 ...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - July 31, 2016 Category: Perinatology & Neonatology Authors: Akane Morita, Hiroko Ushikubo, Asami Mori, Kenji Sakamoto, Tsutomu Nakahara Tags: Research Article Source Type: research

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(Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - July 31, 2016 Category: Perinatology & Neonatology Tags: Issue Information Source Type: research

Effect of fructose on the phosphorylation of AMP ‐activated protein kinase and acetyl‐CoA carboxylase in HepG2 cells stimulated with placental lactogen
CONCLUSIONOur results suggest that fructose treatment reduces triacylglycerol levels via AMPK/ACC signaling in PL‐stimulated hepatocytes. These findings suggest that high fructose intake during pregnancy might impair lipid metabolism in the maternal liver. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 31, 2016 Category: Perinatology & Neonatology Authors: Yuuka Mukai, Fumika Hoshi, Shin Sato Tags: Research Article Source Type: research

Reproductive and neurobehavioral effects of maternal exposure to piperonyl butoxide (PBO) in F1 ‐generation mice
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. With respect to behavioral developmental parameters, swimming direction of female offspring on P...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 31, 2016 Category: Perinatology & Neonatology Authors: Toyohito Tanaka, Akiko Inomata Tags: Research Article Source Type: research

Goldilocks ’ Determination of What New In Vivo Data are “Just Right” for Different Common Drug Development Scenarios, Part 1
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 e...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 31, 2016 Category: Perinatology & Neonatology Authors: Christopher J Bowman, Robert E Chapin Tags: Original Article Source Type: research

TGF ‐β1 monoclonal antibody: Assessment of embryo‐fetal toxicity in rats and rabbits
In conclusion, TGF‐β1 mab produced no adverse maternal or embryo‐fetal findings in rats when administered ≤50 mg/kg on GDs 6, 10, and 14. TGF‐β1 mab did not demonstrate maternal toxicity or embryo‐fetal lethality at doses as high as 30 mg/kg when administered on GDs 7, 12, 14, 16, and 18 in rabbits. Fetal growth and morphology were affected only at 30 mg/kg; thus, the no observed adverse effect level was 3 mg/kg in rabbits. The margin of safety for both rats and rabbits was ≥37‐fold the clinical exposure level. (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 31, 2016 Category: Perinatology & Neonatology Authors: Kim G. Hilbish, Jennifer A. Martin, Anja J. Stauber, Tammye L. Edwards, William J. Breslin Tags: Research Article Source Type: research

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(Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - May 31, 2016 Category: Perinatology & Neonatology Tags: Issue Information Source Type: research

Ovarian Stimulators, Intrauterine Insemination, and Assisted Reproductive Technologies Use and the Risk of Major Congenital Malformations—The AtRISK Study
CONCLUSIONSThe use of ART and IUI was associated with an increased risk of major musculoskeletal and urogenital malformations. ART was associated with a higher risk of MCM compared to ovarian stimulators used alone. Even the adjustment, a contribution of the underlying subfertility problems cannot completely ruled out given the differences in the severity of subfertility (Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 31, 2016 Category: Perinatology & Neonatology Authors: Sonia Chaabane, Odile Sheehy, Patricia Monnier, François Bissonnette, Jacquetta M. Trasler, William Fraser, Anick Bérard Tags: Research Article Source Type: research

Gestational and Early Postnatal Exposure to an Environmentally Relevant Mixture of Brominated Flame Retardants: General Toxicity and Skeletal Variations
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....
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 31, 2016 Category: Perinatology & Neonatology Authors: 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 Tags: Research Article Source Type: research

Preclinical Reproductive and Developmental Toxicity Profile of a Glycine Transporter Type 1 (Glyt1) Inhibitor
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. Brain levels of bitopertin in t...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 31, 2016 Category: Perinatology & Neonatology Authors: Paul Barrow, Neil Parrott, Daniela Alberati, Axel Paehler, Annette Koerner Tags: Research Article Source Type: research

Retinoic Acid and Pitx2 Regulate Early Neural Crest Survival and Migration in Craniofacial and Ocular Development
Congenital eye and craniofacial anomalies are associated with the dysregulation of retinoic acid (RA) levels during embryogenesis. In the present study, we observed that RA and pitx2a cooperatively regulate early cranial neural crest migration from the rhombencephalon to the pharyngeal arches and from the mesencephalon and prosencephalon to the periocular mesenchyme and frontonasal processes. The cranial neural crest tracked toward areas of high RA activity (i.e., developing eye) and circumvented areas of low RA activity (i.e., mesencephalon). Although previous studies have shown that RA increased pitx2a expression at late...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 31, 2016 Category: Perinatology & Neonatology Authors: Bahaar Chawla, Elisa Schley, Antionette L. Williams, Brenda L. Bohnsack Tags: Research Article Source Type: research

Issue Information
(Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology)
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - March 31, 2016 Category: Perinatology & Neonatology Tags: Issue Information Source Type: research

Developmental Toxicity Studies with Pregabalin in Rats: Significance of Alterations in Skull Bone Morphology
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. Subsequent inv...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - January 31, 2016 Category: Perinatology & Neonatology Authors: Dennis C. Morse, Judith W. Henck, Steven A. Bailey Tags: Original Article Source Type: research

An Evaluation of the Impact of PD‐1 Pathway Blockade on Reproductive Safety of Therapeutic PD‐1 Inhibitors
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. PD‐1/PD‐L1‐blocking agents enhance functional activity of the target lymph...
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - January 31, 2016 Category: Perinatology & Neonatology Authors: Frederique M. Poulet, Jayanthi J. Wolf, Danuta J. Herzyk, Joseph J. DeGeorge Tags: Review Article Source Type: research