Results 191 to 200 of about 326,864 (305)

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

Early-stage environmental impact forecasting of chemicals and processes with machine learning and data analytics tools. [PDF]

Clean Technol Environ Policy
Appiah HD, Conway M, Patel J, McMahon M, Hesketh R, Yenkie KM.   +5 more
europepmc   +1 more source

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Impact of secured prescription implementation on ambulatory pregabalin use in France: A regional assessment in the French Nouvelle‐Aquitaine

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The French authorities mandated the use of secure prescriptions for pregabalin on May 2021. This study aimed to evaluate the impact of this measure on pregabalin use and misuse in Nouvelle‐Aquitaine, a southwestern French region with around six million inhabitants.
Maika Munech‐Herran, Véronique Moysan, Bruno Lescarret, Clément Mathieu, Antoine Pariente, Nicolas Rousselot   +5 more
wiley   +1 more source

Modeling of antibody waning after heterologous boosting with Ad5-nCoV in individuals primed with two-dose CoronaVac previously. [PDF]

Hum Vaccin Immunother
Shen R, Jin L, Peng X, Zhou Y, Jin P, Li J.   +5 more
europepmc   +1 more source

Use of antiemetics in early pregnancy 2012–2022: A cross‐sectional study

British Journal of Clinical Pharmacology, EarlyView.
Aim Nausea and vomiting in pregnancy impact quality of life, yet many pregnant women feel dismissed by healthcare professionals, despite the safety of first‐line antiemetic treatments for both mother and fetus. Therefore, this study aims to describe the prevalence of patient‐reported antiemetic use in early pregnancy in Copenhagen, Denmark, the changes
Katrine Bak Wraae, Nanna Roed Ballegaard, Mie Lærkeholm Hede, Line Buchgreitz, Ane Lilleøre Rom, Hanne Kristine Hegaard, Nina Olsén Nathan   +6 more
wiley   +1 more source

Drivers and strategies to combat substandard and falsified medicines in low- and middle-income countries: A systematic review of qualitative evidence. [PDF]

J Med Access
Mekasha YT, Tilahun M, Tegegne AA, Abraham M, Mekonnen AW, Feleke MG.   +5 more
europepmc   +1 more source

Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

British Journal of Clinical Pharmacology, EarlyView.
Christina Gao, Ashley M. Hopkins, Andrew Rowland, Stephen Bacchi   +3 more
wiley   +1 more source

A phase 1 evaluation of inhaled oxytocin: Physiologically‐based pharmacokinetic model informed dosing of a novel heat‐stable oxytocin delivery system

British Journal of Clinical Pharmacology, EarlyView.
Aim To develop and validate a physiologically‐based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non‐pregnant female participants.
Pete Lambert, Carl M. J. Kirkpatrick, Rory Marriott, Siladitya Ray Chaudhuri, David Polidori, Bart Remmerie, Michelle P. McIntosh   +6 more
wiley   +1 more source

Undergraduate students' perception of problem-based learning at the University of Tripoli Alahlia, Libya. [PDF]

J Educ Health Promot
Atia A, Alsherif E, Khamis S, Abdo M, Elfard S, Njaim S.   +5 more
europepmc   +1 more source