Results 221 to 230 of about 192,929 (363)

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

open access: yesBritish 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   +5 more
wiley   +1 more source

European Company Law Experts' Response to the European Commission’s Green Paper 'The EU Corporate Governance Framework'

open access: green, 2011
Paul Davies   +7 more
openalex   +1 more source

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

open access: yesBritish 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   +3 more
wiley   +1 more source

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

open access: yesBritish 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   +4 more
wiley   +1 more source

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