Results 261 to 270 of about 648,282 (342)
Correction to "A disease model predicting placebo response and remission status of patients with ulcerative colitis using modified Mayo score". [PDF]
Clin Transl Scieuropepmc +1 more source
Clinical Pharmacology in Drug Development, EarlyView.Abstract Votoplam is a novel, orally bioavailable, small molecule HTT gene splicing modifier that is being developed for the treatment of Huntington's disease. This was a single dose, open‐label, two‐period, crossover food effect study that evaluated the effect of high‐ and low‐fat meals on 20 mg votoplam in healthy participants. There was a washout of
Lucy Lee +5 more
wiley +1 more source
Real‐World Edoxaban Concentrations in Older Patients Receiving Reduced‐Dose Regimens
Clinical Pharmacology &Therapeutics, EarlyView.Real‐world edoxaban concentrations in older patients receiving reduced‐dose regimens. Low trough concentrations (< 12 ng/mL) were associated with an increased risk of thromboembolism. Among patients meeting the ELDERCARE‐AF criteria, low drug levels were more frequent with the 15 mg regimen than with the 30 mg regimen.
Sung‐Chun Tang +8 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.This manuscript describes the scope of implementation and impact of a regulatory agency‐qualified panel of six urine biomarkers on drug development, the process for which was conducted and funded by the Critical Path Institute, the Foundation for the National Institutes of Health, and the United States Food and Drug Administration.
Tanja S. Zabka +7 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Verekitug, a novel, high‐affinity, fully human monoclonal antibody targeting thymic stromal lymphopoietin receptor (TSLPR), is in development as a potential treatment for severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic obstructive pulmonary disease (COPD).
Dave Singh +9 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Straight to Phase III: Model‐informed approach speeds depemokimab clinical development in interleukin‐5‐driven diseases. IL‐5, a key mediator of type 2 inflammation, underlies various diseases, including severe asthma, CRSwNP, EGPA, and HES. Reduction in blood eosinophil count (BEC), a biomarker of IL‐5 activity, is commonly used to evaluate the ...
Chiara Zecchin +6 more
wiley +1 more source
Delayed clinical improvement is frequently dismissed as placebo, regression to the mean, or nonspecific fluctuation. This interpretation assumes that effective treatment should produce early and clearly attributable responses. This paper challenges that assumption by reframing delayed response as a physiologically plausible outcome in dynamically ...
openaire +1 more source