Results 141 to 150 of about 2,870,899 (307)

Case‐malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy

British Journal of Clinical Pharmacology, EarlyView.
Aim Many women take medications during pregnancy. However, the risk to the fetus from most medications is uncertain. Congenital anomalies are one of the leading causes of infant death and contribute to long‐term disability. Signal detection methods can be used to systematically identify possible medication–anomaly associations that require further ...
Hannah Johnson, Helen Dolk, Maria Loane, Christine Damase‐Michel, Joanne Given, Hedvig Nordeng, Jorieke E. H. Bergman, Iain Carey, Elly Den Hond, Ester Garne, Florence Rouget, Lea Bruneau, Isabelle Monier, Anke Rissmann, Mary O'Mahony, Miriam Gatt, Renée Lutke, Joanna Sichitiu, Elisa Ballardini, Alessio Coi, Clara Cavero Carbonell, David Tucker, Joan Morris   +22 more
wiley   +1 more source

Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.
Anna Lundahl, Jonathan Grigg, Lubna Abuqayyas, Piotr Kuna, Gillian Hunter, Beata Pawlikowska, Jacob Leander, Michael Levin, Atul Gupta, James Paton, Katharine C. Pike, Jane R. Parnes, Gun Almqvist, Stephanie L. Roseti, on behalf of the study investigators   +14 more
wiley   +1 more source

Extrapolation and pharmacokinetic protocol design optimization for ceftriaxone as an exemplar for the development of antibiotics for children

British Journal of Clinical Pharmacology, EarlyView.
Aim Ceftriaxone is a cephalosporin commonly used for the treatment of acute, severe infections; however, there are conflicting data on its disposition properties in children, making it a suitable case study for the evaluation of the appropriateness of extrapolation approaches based on exposure matching principles for paediatric patients and exploring ...
Daniel Valente Neves, Umberto Villani, Salvatore D'Agate, Sean Oosterholt, Ricardo de Carvalho Cavalli, Fabio Carmona, Vera Lucia Lanchote, Oscar Della Pasqua   +7 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

The impact of medication shortages on paediatric care: A retrospective impact analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg, Laurens Christiaan van Rijn, Elisabeth Johanna Ruijgrok, Sinno Henricus Paulus Simons, Brigitta Carolina Maria Witjes, Jan‐Dietert Christoffer Brugma, Robert Bernard Flint   +6 more
wiley   +1 more source

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

British Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang, Daniala L. Weir, Safana Thevasahayam, Vera H. M. Deneer, Arno Siebes, Helga Gardarsdottir   +5 more
wiley   +1 more source

An investigtion of the polymicrobial nature of lower respiratory tract infections in cystic fibrosis patients [PDF]

Cystic fibrosis (CF) is a genetically inherited condition most prevalent amongst Caucasians. In previous studies, it has been demonstrated that bacterial, fungal and viral pathogens cause lung function decline and ultimately result in death due to ...
Nelson, Andrew
core  

Histamine and the mechanisms of nausea and vomiting: Translating the uncertain pharmacology of cyclizine

British Journal of Clinical Pharmacology, EarlyView.
Abstract Cyclizine is a long‐established, short‐acting drug, registered for preventing motion sickness, post‐operative nausea and vomiting (PONV) and ‘vomiting of known cause’. The latter is not defined but may include pregnancy and patients receiving palliative care, historically accepted without large, controlled trials.
Gareth J. Sanger, Paul L. R. Andrews
wiley   +1 more source

Ceftriaxone‐associated immune haemolytic anaemia: A patient‐level systematic review

British Journal of Clinical Pharmacology, EarlyView.
Abstract Ceftriaxone can cause acute haemolysis. Its clinical presentation, risk factors, and outcomes remain incompletely characterized. We conducted a systematic review of published cases with patient‐level data, following international guidelines and with registration in PROSPERO (CRD420261338709). Reports were identified through three bibliographic
Sonja Miotti, Giada Wyttenbach, Mario G. Bianchetti, Camilla Lavagno, Pietro Camozzi, Gregorio P. Milani, Renato Gualtieri, Sebastiano A. G. Lava, Pietro B. Faré, Simone Janett   +9 more
wiley   +1 more source

Eudragit®‐engineered pH‐responsive probiotic microspheres with enhanced gastrointestinal resistance and prolonged storage stability for inflammatory bowel disease therapy

BMEMat, EarlyView.
This study reports the development of AMS@Eud core‐shell microspheres, combining calcium alginate and pH‐responsive Eudragit® L100, which exhibit exceptional gastrointestinal resistance and long‐term storage stability (only 5.28%–9.09% viability loss over 35 days at 4–25°C), and effectively alleviate inflammatory bowel disease via gut microbiota ...
Ming Teng, Xiaomin Luo, Peng Zhang, Chen Yang, Yuniel Ma, Xinhua Liu   +5 more
wiley   +1 more source