Results 191 to 200 of about 489,387 (266)

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

Main factors associated with variability in the assessment of the objective response rate. A re‐analysis of the PHEREXA phase 3 clinical trial

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Local investigators (LIs) overestimate the objective response rate (ORR) in comparison to Blinded Independent Central Reviewers (BICR) in oncology. In this study, we re‐analysed data obtained in the PHEREXA trial (NCT01026142) with the following aims: i) to confirm at the single‐patient level the discrepancy observed by analysing ...
Gennaro Daniele   +3 more
wiley   +1 more source

Alkaline Phosphatase Supplementation During Hypothermic and Normothermic Machine Perfusion Improves Metabolic Dysfunction in a Porcine Model of Donor Kidney Preservation. [PDF]

open access: yesTransplant Direct
Steenvoorden TS   +8 more
europepmc   +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

Pharmacokinetic‐pharmacodynamic modelling of risankizumab using chronic plaque psoriasis real‐world data

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Risankizumab is a high‐cost biologic treatment for chronic plaque psoriasis, an immune‐mediated inflammatory disease presenting with painful red scaly skin lesions. Inter‐individual heterogeneity in treatment response may be better addressed with personalised rather than fixed dosing. We sought to develop a pharmacokinetic/pharmacodynamic (
Charlotte M. Thomas   +16 more
wiley   +1 more source

GLP‐1 agonists and the gut microbiome: A bidirectional relationship

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Glucagon‐like peptide‐1 (GLP‐1) receptor agonists have transformed the management of type 2 diabetes mellitus (T2DM) and obesity, yet their interactions with the gut microbiome remain an emerging frontier in pharmacological and metabolic research.
Srinivas Kamath   +2 more
wiley   +1 more source

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