Results 181 to 190 of about 222,638 (263)

Interaction of the Gut Microbiota and the Enteric Nervous System: Implications in Gastrointestinal Disorders Associated With Autism Spectrum Disorder

open access: yesAutism Research, EarlyView.
ABSTRACT Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by impairments in social interaction, restricted interests, and repetitive behaviors. In addition to these core behavioral symptoms, gastrointestinal (GI) disorders are frequently reported, ranging from severe constipation to diarrhea.
Baptiste Ganachaud   +9 more
wiley   +1 more source

Setting up mother–infant pair lactation studies with biobanking for research according to regulatory requirements

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Within the ConcePTION project we set out to design two mother–infant pair studies collecting breast milk and plasma from the mother and plasma from the infant (for metformin and prednisolone) in order to demonstrate the premises and conditions for investigating potential drug transfer in association with breastfeeding.
Mats Hansson   +11 more
wiley   +1 more source

Zuranolone: A case study in (regulatory) rush to judgement?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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

A phase 1 evaluation of inhaled oxytocin: Physiologically‐based pharmacokinetic model informed dosing of a novel heat‐stable oxytocin delivery system

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim To develop and validate a physiologically‐based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non‐pregnant female participants.
Pete Lambert   +6 more
wiley   +1 more source

PrEP at the site of action in cisgender and transgender women: A pharmacology study of blood and rectal CD4+ lymphocytes

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Background Female sex hormones used in feminizing hormone therapy (FHT) may influence activation and persistence of HIV pre‐exposure prophylaxis (PrEP) medications. The clinical relevance of this interaction remains unclear, particularly for transgender and cisgender women (TGW and CGW).
Elizabeth Hastie   +10 more
wiley   +1 more source

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink   +9 more
wiley   +1 more source

Editorial: Plasticity and flexibility in the parental brain

open access: yesFrontiers in Behavioral Neuroscience
Natalia Uriarte, Mariana Pereira
doaj   +1 more source

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