Results 271 to 280 of about 648,282 (342)

Quantitative Systems Toxicology Modeling with DILIsym to Support Phase 3 Dose Selection for Fezolinetant

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Fezolinetant is a first‐in‐class, selective, non‐hormonal, neurokinin 3 receptor antagonist that is approved for the treatment of moderate to severe vasomotor symptoms due to menopause. In a phase 2b clinical study (n = 352), nine study participants experienced elevations in serum transaminases exceeding three times the upper limit of normal.
Jace C. Nielsen   +11 more
wiley   +1 more source

Population Pharmacokinetics of Clesrovimab in Preterm and Full‐Term Infants

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Clesrovimab is a half‐life extended monoclonal antibody targeting the respiratory syncytial virus fusion protein. Three studies (phase Ib/IIa [MK‐1654‐002], phase IIb/III [CLEVER], and phase III [SMART]) were conducted to evaluate the efficacy, safety, and pharmacokinetics (PK) of clesrovimab in infants.
Ziheng Hu   +8 more
wiley   +1 more source

Population Pharmacokinetic and Exposure‐Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post‐Exposure Prophylaxis in Children

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Baloxavir acid (baloxavir), the active metabolite of the prodrug baloxavir marboxil, is a selective inhibitor of the influenza virus cap‐dependent endonuclease. The population pharmacokinetic (popPK) profile of baloxavir in adults/adolescents has been described previously.
Sylvie Retout   +6 more
wiley   +1 more source

Longitudinal Tumor Size and Survival Modeling for Exposure–Response Analysis of Drugs with Frequent Dose Reductions: Dose Justification of Abemaciclib in Patients with Metastatic Breast Cancer

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Abemaciclib is an oral anticancer drug indicated for treatment of HR+ HER2‐ breast cancer. Dose modifications due to side effects are frequent, thus drug exposures change over time as a result of altering the dose or temporarily withholding abemaciclib treatment.
Emmanuel Chigutsa   +2 more
wiley   +1 more source

Mandated ESG Disclosure and Its Effects on Earnings Quality and Cost of Capital: Evidence From European Stock Markets

open access: yesCorporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT This study investigates the causal effects of mandated ESG disclosure on two key corporate financial outcomes: earnings quality and cost of capital. Using a panel dataset of 210 publicly listed firms from eight European Union countries between 2015 and 2024, the study exploits cross‐country variation in the timing and intensity of ESG ...
Isik Akin, Meryem Akin
wiley   +1 more source

Role of selenium in the pathophysiology of cardiorenal anaemia syndrome

open access: yesESC Heart Failure, Volume 12, Issue 2, Page 770-780, April 2025.
Abstract Chronic kidney disease (CKD) and cardiovascular disease (CVD) have multiple bidirectional mechanisms, and anaemia is one of the critical factors that are associated with the progression of the two disorders [referred to as cardiorenal anaemia syndrome (CRAS)].
Shigeyuki Arai   +2 more
wiley   +1 more source

Gut microbiota‐related modulation of immune mechanisms in post‐infarction remodelling and heart failure

open access: yesESC Heart Failure, Volume 12, Issue 2, Page 942-954, April 2025.
Abstract The immune system has long been recognized as a key driver in the progression of heart failure (HF). However, clinical trials targeting immune effectors have consistently failed to improve patient outcome across different HF aetiologies. The activation of the immune system in HF is complex, involving a broad network of pro‐inflammatory and ...
Johann Roessler   +4 more
wiley   +1 more source

Transthyretin amyloid cardiomyopathy: Literature review and red‐flag symptom clusters for each cardiology specialty

open access: yesESC Heart Failure, Volume 12, Issue 2, Page 955-967, April 2025.
Abstract Wild‐type transthyretin amyloid cardiomyopathy (ATTRwt‐CM) is a progressive and infiltrative cardiac disorder that may cause fatal consequences if left untreated. The estimated survival time from diagnosis is approximately 3–6 years. Because of the non‐specificity of initial symptom manifestation and insufficient awareness among treating ...
Yasuhiro Izumiya   +9 more
wiley   +1 more source

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