Results 131 to 140 of about 226,969 (309)

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

British 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, Ida Björkgren, Jenny Svedenkrans, Helena Backman, Jarl Hellman, Linda Englund‐Ögge, Mikaela Magnusson, Inger Lindström, Andrea Wutte, Erica Sundell, Pawel Baranczewski, Laura Shaughnessy   +11 more
wiley   +1 more source

Trends and variation in the use of andexanet alfa for the reversal of direct oral anticoagulants in NHS trusts in England

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Andexanet alfa was recommended by the National Institute for Health and Clinical Excellence (NICE) as an option in the management of life‐threatening gastrointestinal bleeding in patients taking apixaban or rivaroxaban in May 2021. A recent UK‐wide survey of local hospital protocols for the use of andexanet alfa suggested that practice ...
Louis Fisher, Richard Buka, Rosalind Byrne, Stephen Black, Helen J. Curtis, Christopher Wood, Andrew Brown, Sebastian Bacon, Richard Croker, Ben Goldacre, Brian MacKenna, Victoria Speed   +11 more
wiley   +1 more source

Immunogenicity of fractional and standard dose COVID-19 vaccine boosters among healthy adults in Indonesia: twenty four month follow-up from a randomised controlled trial

Nature Communications
Although many high-income countries have regular COVID-19 vaccine booster schedules, there are limited data on the protective effects of some heterologous booster combinations.
John D. Hart, Eddy Fadlyana, Nadia Mazarakis, Nina Dwi Putri, Emma Watts, Kerryn A. Moore, Eleanor F. G. Neal, Djatnika Setiabudi, Muhammad Gilang Dwi Putra, Cattram Nguyen, Aqila Sakina Zhafira, Pratama Wicaksana, Robert Sinto, Dwi Oktavia, Rini Fajarani, Agnes Rengga Indrati, Chrysanti Murad, Yovita Hartantri, Hendarsyah Suryadinata, Yulia Sofiatin, Kusnandi Rusmil, Hindra I. Satari, Sri Rezeki. Hadinegoro, Cissy B. Kartasasmita, Julitasari Sundoro, Paul V. Licciardi, Claire von Mollendorf, Edward K. Mulholland   +27 more
doaj   +1 more source

Pharmacokinetic‐pharmacodynamic modelling of risankizumab using chronic plaque psoriasis real‐world data

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Risankizumab is a high‐cost biologic treatment for chronic plaque psoriasis, an immune‐mediated inflammatory disease presenting with painful red scaly skin lesions. Inter‐individual heterogeneity in treatment response may be better addressed with personalised rather than fixed dosing. We sought to develop a pharmacokinetic/pharmacodynamic (
Charlotte M. Thomas, Jessica Ruoheng Wei, David Baudry, Zehra Arkir, Bola Coker, Tejus Dasandi, Kingsley Powell, Monica Arenas‐Hernandez, Jenny Leung, Krystal Rawstron, Chioma Nwaogu, Richard Woolf, Andrew E. Pink, Jonathan Barker, Joseph F. Standing, Catherine H. Smith, Satveer K. Mahil   +16 more
wiley   +1 more source

Early clinical pharmacology evaluation of the novel anti‐inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims This work assessed the pharmacokinetics (PK), safety and tolerability of glasmacinal (EP395, an oral anti‐inflammatory macrolide with negligible antimicrobial activity in development for COPD treatment) in two healthy participant trials: ‘first‐in‐human’ (FIH) and ‘drug–drug‐interaction’ (DDI).
Dave Singh, Kate Hanrott, Olof Breuer, Johan Bylund, Björn Schultze, Virginia Norris   +5 more
wiley   +1 more source

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

Accuracy of human epidermal growth factor receptor 2 (HER2) immunohistochemistry scoring by pathologists in breast cancer, including the HER2-low cutoff

Diagnostic Pathology
Background Breast cancer was previously categorized as human epidermal growth factor receptor 2 (HER2)-positive (immunohistochemistry [IHC] 3+, IHC 2+ / in situ hybridization [ISH]–positive) or HER2-negative (IHC 0, IHC 1+, IHC 2+/ISH−).
Agata Wróbel, Michel Vandenberghe, Marietta Scott, Frances Jones, Tsuyoshi Matsuo, Anne-Marie Boothman, Jessica Whiteley, Craig Barker   +7 more
doaj   +1 more source

Therapeutic drug monitoring of antimicrobials in a paediatric setting: A retrospective single‐centre study

British Journal of Clinical Pharmacology, EarlyView.
Aims Paediatric pharmacokinetics differ significantly from adults due to age‐related physiological changes, necessitating precise dose adjustments. However, data on therapeutic drug monitoring (TDM) implementation in paediatric setting remain limited.
Gianluca Gazzaniga, Stefano Agliardi, Riccardo Giossi, Alice Schianchi, Alessandra Romandini, Thomas Virdis, Silvia Nerini Molteni, Maria Luisa De Angelis, Stefania Paccagnini, Cecilia Gechtman, Alice Proto, Marco Fossati, Silvia Oliveri, Giulia Angela Pattarino, Elena Altieri, Agnese Graziosi, Arianna Pani, Romano Danesi, Stefano Martinelli, Costantino De Giacomo, Francesco Scaglione   +20 more
wiley   +1 more source

Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium‐glucose cotransporter 2 inhibitor users

British Journal of Clinical Pharmacology, EarlyView.
Abstract Introduction Active surveillance of adverse events using healthcare data is emerging as complementary to the monitoring of spontaneous reports and stand‐alone pharmacoepidemiologic studies. The risk of urinary tract infections (UTIs) was listed as a special warning for sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) when marketed in Europe
Haoxin Le, Dilsad Simay Peker, Lukas Frederic Westphal, Nikolai Brun, Christine Erikstrup Hallgreen, Morten Andersen   +5 more
wiley   +1 more source

Increasing the reporting of adverse drug reaction‐related hospitalizations using an ICD‐10‐based identification workflow: A multicentre study from Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Background Reporting adverse drug reactions (ADRs) is essential for drug safety. In Switzerland, healthcare professionals are legally required to report serious and unlabelled ADRs, yet under‐reporting remains widespread. We tested a novel method to increase reporting of ADR‐related hospitalizations.
Georgia Anita Weber, Sophie‐Charlotte Bartel, Michael Boch, Christoph Rosen, Michael Bodmer, Balthasar Luzius Hug, Thomas Stammschulte, Patrick E. Beeler   +7 more
wiley   +1 more source