Results 181 to 190 of about 399,874 (258)

A scoping review of thresholds for responder and time‐to‐event analysis of patient‐reported outcomes in breast cancer trials

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Patient‐reported outcomes (PROs) are essential for assessing clinical benefit and tolerability from the patient's perspective. In oncology trials, PRO data analysis often involves responder and time‐to‐event analyses, which depend on predefined thresholds to determine clinically meaningful change.
Anna Margarete Maria Thurner   +5 more
wiley   +1 more source

Blood pressure effects of SGLT2 inhibitors and GLP‐1 receptor agonists: Mechanisms, trial evidence and Real‐world data

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
SGLT2 inhibitors and GLP‐1 receptor agonists modestly lower blood pressure across diverse patient populations, including those without diabetes. These effects appear largely independent of glycaemic control and offer additive value in high‐risk patients with overlapping comorbidities.
Andrej Belančić   +7 more
wiley   +1 more source

An open‐label, single‐arm, dose‐escalating concentration–QT study to investigate the cardiac effects and safety of paroxetine in healthy adults

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Paroxetine is a selective serotonin reuptake inhibitor (SSRI), approved for treatment of major depressive disorder and anxiety disorders. Some SSRIs are known to prolong the QT interval; however, clinical evidence to establish a lack of association between paroxetine and corrected QT interval (QTc) prolongation is limited. Therefore, this
Sven C. van Dijkman   +6 more
wiley   +1 more source

Low‐intervention clinical trials in Spain: Do they progress?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza   +4 more
wiley   +1 more source

Hypnotic doses of fazamorexant induced less impairment on balance and cognition than zolpidem in healthy younger and elderly individualse

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Fazamorexant is a dual orexin receptor antagonist being developed for the treatment of insomnia. This study aims to determine the dose‐exposure‐response relationship of single‐dose fazamorexant vs. zolpidem in young adult and elderly healthy Chinese volunteers. Methods This single‐centre, randomized, double‐blind, double‐dummy, placebo‐ and active‐
Chen Xia   +3 more
wiley   +1 more source

Cannabinoids and drug–drug pharmacokinetic interactions: Deciphering the risks

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
The relationship between cannabinoids and mental health has become a major focus of scientific inquiry and public discourse. Cannabinoids are diverse chemical compounds from the Cannabis species that have been explored for their therapeutic applications in treating chronic pain, psychiatric and neurological conditions, such as depression, schizophrenia,
Paraskevi Papakyriakopoulou   +2 more
wiley   +1 more source

Model‐informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Population pharmacokinetic (popPK) and pharmacokinetic‐pharmacodynamic (PK/PD) models were developed to support clinical development of nemolizumab, a humanized monoclonal antibody targeting the IL‐31 receptor α, in adolescents and adults with moderate‐to‐severe atopic dermatitis (AD).
Floris Fauchet   +17 more
wiley   +1 more source

Risk of cardiac, neuropsychiatric and musculoskeletal adverse events with levothyroxine: Systematic review

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Levothyroxine (LT4) is the standard treatment for hypothyroidism and the most widely prescribed medication worldwide. Although generally safe, regulatory reports list potential cardiac, neuropsychiatric and musculoskeletal adverse events (AEs). Clarifying their clinical relevance is essential.
Bala Swetha Baskaran   +2 more
wiley   +1 more source

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