Results 141 to 150 of about 2,586,015 (308)

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 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

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

Safety and pharmacokinetics of inhaled aloxistatin: A first‐in‐human phase 1 dose escalation trial

British Journal of Clinical Pharmacology, EarlyView.
Aims Aloxistatin (E64d) is a membrane‐permeable cysteine protease inhibitor prodrug that is converted by esterases to the active metabolite E64c (loxistatin). This first‐in‐human study evaluated the safety, tolerability and pharmacokinetics of single ascending doses of inhaled E64d in healthy volunteers.
Sebastian Fähndrich, Franziska Friedrich, Daniel Soriano, Jona Gjeloshi, Björn C. Frye, Xuan Phuoc Nguyen, Lydia Herbstritt, Caroline von Spee‐Mayer, Britta Lang, Fabrice Nollevaux, Andreas Hoheisel, Dorothee Winterberg, Armin Braun, Thomas Epting, Christine Contini, Karl Winkler, Thomas Reinheckel, Franziska C. Trudzinski, Gernot Rohde, Daiana Stolz, Robert Bals, Martin J. Hug, Sebastian Wirtz, Christoph Peters, Carolin Jenkner   +24 more
wiley   +1 more source

The global extent of polypharmacy in neonatal intensive care: A systematic review

British Journal of Clinical Pharmacology, EarlyView.
Aims Pharmaceutical treatment in the neonatal intensive care unit (NICU) is challenging, with neonates often receiving multiple drugs during hospitalization. Given their physiological immaturity, polypharmacy raises concerns about potential adverse effects, drug–drug interactions and the risk of supratherapeutic or subtherapeutic treatment.
Mia Finserås Bretun, Ditte Resendal Gotfredsen, Aase Merethe Raddum, Charlotte Vermehren, Jón Þór Trærup Andersen, Ulrik Lausten‐Thomsen, Christina Gade   +6 more
wiley   +1 more source