Results 191 to 200 of about 1,676,195 (294)

Unintended Pregnancies and Breastfeeding Studies during Central Nervous System Drug Development: How Are they Handled, Is There Room for Improvement?: Maintaining the Gap: Pregnancy and Breastfeeding in CNS Clinical Trials. [PDF]

Clin Pharmacol Ther
Pregnant and breastfeeding individuals are routinely excluded from clinical drug development, creating persistent evidence gaps in pharmacology, safety, and dosing. Despite mandatory contraception and pregnancy testing, unintended pregnancies occur, particularly during the development of central nervous system (CNS) medicines used by women of ...
Schoenmakers S, Bakker C, Ganev A, Butlen-Ducuing F, de Vries CS.   +4 more
europepmc   +2 more sources

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source

Can time-lapse culture combined with artificial intelligence improve ongoing pregnancy rates in fresh transfer cycles of single cleavage stage embryos? [PDF]

Front Endocrinol (Lausanne)
Wang X, Wei Q, Huang W, Yin L, Ma T.
europepmc   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Dose‐related propofol resistance in COVID‐19 patients: Altered drug plasma levels, mechanistic insights from neuronal‐derived extracellular vesicles and miRNA analysis

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Critical care for COVID‐19 patients presents unique challenges, particularly in sedation management. Patients demonstrate notable dose‐related resistance to propofol, potentially due to complex pharmacokinetic alterations. Emerging evidence suggests that plasma extracellular vesicle‐associated miRNA represents valuable predictive ...
Debora Curci, Carlotta Bidoli, Marco Gerdol, Charisse Winston, Robert A. Rissman, Giuliana Decorti, Antonella Fabretto, Andrea Taddio, Gabriele Stocco, Erik Roman‐Pognuz, Marianna Lucafò   +10 more
wiley   +1 more source

CYP3A5 genetic variability influences sildenafil and metabolite in pulmonary hypertension

British Journal of Clinical Pharmacology, EarlyView.
Aim Interindividual variability in sildenafil response among pulmonary hypertension patients (PH) may be influenced by CYP3A5 polymorphisms. CYP3A5*3 allele reduces CYP3A5 activity and affects sildenafil metabolism. This study investigated the associations between CYP3A5 genotype and plasma concentrations of sildenafil and N‐desmethyl sildenafil, as ...
Pranisa Wongwien, Burabha Pussadhamma, Sirimas Kanjanawart, Thikhumporn Areesinpitak, Nontaya Nakkam, Chingching Foocharoen, Wichittra Tassaneeyakul, Suda Vannaprasaht   +7 more
wiley   +1 more source

Lithium‐related adverse drug reactions in children: A case–control study comparing lithium to second‐generation antipsychotics in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to improve the understanding of lithium's safety profile by analysing the frequency and distribution of reported adverse drug reactions (ADRs) compared to second‐generation antipsychotics (SGAs). Methods Individual case safety reports from VigiBase (1968–October 2023) involving individuals older than 2 years, with lithium or SGAs ...
Lisa T. Ringeling, Ravish N. Gangapersad, Lillian Lieuw, Patrick C. Souverein, Eibert R. Heerdink, Pilar Garcia‐Gomez, Manon H. J. Hillegers, Birgit C. P. Koch, Bram Dierckx   +8 more
wiley   +1 more source

Analysis of clinical investigation (device) initial submissions received by the Medicines and Healthcare products Regulatory Agency between January 2022 and December 2025

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to analyse clinical investigation‐device initial submissions received by the MHRA between January 2022 and December 2025. Methods Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not included. The predefined primary end‐point was submission type.
Andrea Manfrin, Mark Grumbridge, Daniel Hill, Crina Cacou, Graham Warren, James Pound, Jacob George, Alejandro F. Frangi   +7 more
wiley   +1 more source

Prevalence of pregnancy and birth outcomes following biologic exposure in immune‐mediated inflammatory diseases: A population‐based study

British Journal of Clinical Pharmacology, EarlyView.
Aims Almost 5% of pregnancies are affected by immune‐mediated inflammatory diseases (IMIDs). As treatments become available, understanding their use during pregnancy is important. We aimed to describe maternal, pregnancy and infant outcomes among IMID pregnancies exposed to biologic therapies. Methods Using the Merative™ MarketScan® Commercial Database,
Leah K. Flatman, Lisiane F. Leal, Gabra Nohmie, Anick Bérard   +3 more
wiley   +1 more source

Selective feticide in dichorionic diamniotic (DCDA) twins complicated with previable premature rupture of membrane before 24 weeks may be a safe therapeutic alternative to ongoing pregnancy. [PDF]

BMC Pregnancy Childbirth
Zhu C, Liu H, Zhu H, Huang L.
europepmc   +1 more source