Results 201 to 210 of about 3,602,513 (298)

Pharmacokinetics, safety, tolerability and fluorescence imaging of nizaracianine triflutate administered in three divided doses to healthy volunteers

British Journal of Clinical Pharmacology, EarlyView.
Aim Fluorescence‐guided surgery enhances intraoperative visualization of anatomical structures. Nizaracianine is a near‐infrared fluorescent agent that is exclusively renally cleared in animal models. It enables real‐time ureteral imaging and identification, potentially reduces risk of injury and facilitates assessment before surgical closure.
Lisanne K. A. Neijenhuis, Cedric M. W. Pesch, John V. Frangioni, Alexander L. Vahrmeijer, Jacobus Burggraaf, Naomi B. Klarenbeek   +5 more
wiley   +1 more source

Constructing a single market for pharmaceuticals in the EU: what's the price? [PDF]

Health Econ Policy Law
Kleinhout-Vliek T, Geiger S, Hagendijk R, Hilberg E, Martin P, Perehudoff K, Wadmann S, Wested J.   +7 more
europepmc   +1 more source

Long‐term impact of Elexacaftor/Tezacaftor/ivacaftor on pulmonary, nutritional and metabolic outcomes in homozygous F508del cystic fibrosis patients: A real‐world cohort study

British Journal of Clinical Pharmacology, EarlyView.
Aim Elexacaftor/tezacaftor/ivacaftor (ETI) has markedly improved cystic fibrosis (CF) outcomes. However, its long‐term impact on nutrition, metabolism and liver health remains underexplored. We assessed 30‐month changes in pulmonary, nutritional, metabolic and inflammatory markers in people with CF (PwCF) homozygous for F508del.
Nicola Perrotta, Luigi Angelo Fiorito, Roberta Vescovo, Anna Virgilio, Giulia Amato, Giuseppe Cimino   +5 more
wiley   +1 more source

Children's drug research and development incentives and market pricing optimization based on medical imaging. [PDF]

Sci Rep
Mu X, Wu L.
europepmc   +1 more source

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

Assessment of some factors that influence the productiveness and competitive performance of local pharmaceutical manufacturing companies in a low-income country setting: The case of Ethiopia. [PDF]

PLOS Glob Public Health
Anley Y, Kerie Anagaw Y, Mekete Alemu F, Ashenef A.   +3 more
europepmc   +1 more source

Community pharmacists' practices and perspectives on deprescribing high‐risk psychotropic medicines: National survey findings

British Journal of Clinical Pharmacology, EarlyView.
Aim To explore the practices, confidence and perspectives of community pharmacists in deprescribing high‐risk psychotropic medicines, including opioid analgesics, benzodiazepine, gabapentinoids and medicinal cannabis. Methods An anonymous, cross‐sectional national online survey was conducted between January and April 2025 among Australian community ...
Monica Jung, Louisa Picco, Aili V. Langford, Rose Laing, Jana Dostal, Suzanne Nielsen   +5 more
wiley   +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

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

Equitable access to essential medicines to treat neglected tropical diseases: Latest developments from the World Health Organization (WHO). [PDF]

PLoS Negl Trop Dis
Fattah F, Lester R, Kalua K, Sharp B, Wasan KM.   +4 more
europepmc   +1 more source