Results 211 to 220 of about 6,520,892 (282)

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

Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178). [PDF]

EFSA J
EFSA Panel on Genetically Modified Organisms (GMO), Mullins E, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sanchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Afonso A, Lenzi P, Papadopoulou N, Raffaello T.   +21 more
europepmc   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Plain Language Summary of the Scientific opinion on welfare of horses at slaughter. [PDF]

EFSA J
europepmc   +1 more source

Trends in publicly subsidized and private access to GLP‐1 medicines indicated for type 2 diabetes in Australia, 2020–2025

British Journal of Clinical Pharmacology, EarlyView.
Aims GLP‐1 medicines provide substantial cardio‐renal benefits for type 2 diabetes (T2D) and are increasingly used for weight loss. Most high‐income countries subsidize access for T2D with restrictions; use outside of these restrictions occurs through private prescriptions. Despite strong consumer demand, the extent of private access to GLP‐1 medicines
Michael O. Falster, Juliana de Oliveira Costa, Tamara Y. Milder, Joanne Carson, Cade Shadbolt, Brendon L. Neuen, Clare Arnott, Andrew Wilson, Min Jun, Nicole Pratt, Sallie‐Anne Pearson   +10 more
wiley   +1 more source

The impact of pharmacogenetic‐informed care on medication adherence and psychological factors associated with adherence: A narrative review

British Journal of Clinical Pharmacology, EarlyView.
Improvement in medication adherence is often proposed as a potential advantage of pharmacogenetic‐guided prescribing over a traditional one‐size‐fits‐all approach. This paper provides a review of the published literature and presents the findings of studies that measure adherence to medication as an outcome of pharmacogenetic‐informed care, or that ...
Lucy Galloway, Alison Wright, John Weinman   +2 more
wiley   +1 more source

Scientific opinion on the modification of the terms of authorisation of the preparations of <i>Lactiplantibacillus plantarum</i>CNCM I-3235, <i>Pediococcus acidilactici</i>CNCM I-3237, <i>Pediococcus pentosaceus</i>NCIMB 12455, <i>Acidipropionibacterium acidipropionici</i>CNCM I-4661 and <i>Lentilactobacillus hilgardii</i>CNCM I-4785 as feed additives for all animal species (Danstar Ferment AG). [PDF]

EFSA J
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Villa RE, Azimonti G, Bonos E, Christensen H, Durjava M, Dusemund B, Gehring R, Glandorf B, Kouba M, López-Alonso M, Marcon F, Nebbia C, Pechová A, Prieto-Maradona M, Theodoridou K, Anguita M, Brozzi R, Galobart J, Sandalli S.   +19 more
europepmc   +1 more source

Adaptive imatinib regimens can mitigate cumulative toxicity while sustaining hemodynamic benefit: A model‐based simulation of the positioning imatinib for pulmonary arterial hypertension trial

British Journal of Clinical Pharmacology, EarlyView.
ABSTRACT Aims Imatinib improves hemodynamics in pulmonary arterial hypertension (PAH), but dose‐dependent toxicity has limited its clinical development. We aimed to quantify the dose–efficacy–toxicity relationship and evaluate alternative dosing strategies using data from the PIPAH trial.
Medhat M. Said, Robert B. de Mooij, Dian Jiao, Reitze J. Ovelgonne, Rami Biram, Juan Delgado‐SanMartin, Alexander M. K. Rothman, Sofia S. Villar, Andreas A. Roussakis, Jurjan Aman, Ron A. A. Mathôt, Eleonora L. Swart, Martin R. Wilkins, Imke H. Bartelink   +13 more
wiley   +1 more source

Scientific opinion as regards the specifications of the food additives acetic, lactic, tartaric, mono- and diacetyltartaric, mixed acetic and tartaric acids esters of mono- and diglycerides of fatty acids (E 472a,b,d,e,f). [PDF]

EFSA J
EFSA Panel on Food Additives and Flavourings (FAF), Castle L, Andreassen M, Aquilina G, Bastos ML, Boon P, Fallico B, FitzGerald R, Frutos Fernandez MJ, Grasl-Kraupp B, Gundert-Remy U, Gürtler R, Houdeau E, Kurek M, Louro H, Passamonti S, Fürst P, Karlien C, Mirat M, Tard A, Rincon AM.   +20 more
europepmc   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source