Zuranolone: A case study in (regulatory) rush to judgement?
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove +4 more
wiley +1 more source
Objectives To explore the longitudinal associations between maternal sleep, anxiety, depression across pregnancy trimesters and adverse pregnancy outcomes. Methods A prospective cohort study was conducted in a maternal and child health hospitals in China
Qingxiang Zheng +6 more
doaj +1 more source
Bile acids during pregnancy: Trimester variations and associations with glucose homeostasis. [PDF]
Gagnon M +6 more
europepmc +1 more source
Use of antiemetics in early pregnancy 2012–2022: A cross‐sectional study
Aim Nausea and vomiting in pregnancy impact quality of life, yet many pregnant women feel dismissed by healthcare professionals, despite the safety of first‐line antiemetic treatments for both mother and fetus. Therefore, this study aims to describe the prevalence of patient‐reported antiemetic use in early pregnancy in Copenhagen, Denmark, the changes
Katrine Bak Wraae +6 more
wiley +1 more source
Plasma lipids relationship with results of Oral Glucose Challenge Test in pregnancy
Objective: This study aimed to evaluate the correlation between plasma lipid levels at first trimester of pregnancy and results of Oral Glucose Challenge Test (OGCT).
Soraya Salehi Gargari +4 more
doaj
Social Determinants of Smoke Exposure During Pregnancy: Findings From Waves 1 & 2 of the Population Assessment of Tobacco and Health (PATH) Study [PDF]
Maternal smoking during pregnancy (MSDP) and secondhand smoke (SHS) exposure are associated with a myriad of negative health effects for both mother and child.
Do, Elizabeth K. +3 more
core +1 more source
Background Thiopurines are used to maintain remission in inflammatory bowel disease (IBD). These drugs are metabolized into 6‐thioguanine nucleotides (6‐TGN), associated with efficacy, and 6‐methylmercaptopurine ribonucleotides (6‐MMPR), associated with adverse drug reactions. Pregnancy has been linked to a shift in thiopurine metabolism, characterized
Dianne G. Bouwknegt +13 more
wiley +1 more source
Investigating the factors related to the brain executive function change during pregnancy
Objectives Some studies indicate cognitive defects during pregnancy, but the factors affecting these defects have not been addressed. Therefore, the present study aims to determine the impressive factors in executive function during pregnancy.
Saeideh Iranshahi +5 more
doaj +1 more source
Maternal obesity is associated with the formation of small dense LDL and hypoadiponectinemia in the third trimester [PDF]
Context: Maternal obesity is associated with high plasma triglyceride, poor vascular function, and an increased risk for pregnancy complications. In normal-weight pregnant women, higher triglyceride is associated with increased small, dense low-density ...
Brown, E.A. +9 more
core +2 more sources
PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing
Model‐informed drug development is increasingly integrated across the drug development continuum, enabling more efficient, cost‐effective, and targeted trials while reducing reliance on animal studies. Achieving pharmacoequity requires not only equitable access to medicines but also to the data and knowledge that inform drug development and regulatory ...
Shakir Atoyebi +6 more
wiley +1 more source

