Results 111 to 120 of about 373,154 (280)
Principles of Use of Biostatistics in Research
Veena Manja, Satyan Lakshminrusimha
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Biostatistics - Referees of Manuscripts Submitted Mid-2008 to Mid-2009 [PDF]
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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
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Editorial: Bioinformatics and Biostatistics Applications in Tobacco Smoking Research [PDF]
Mohammed A. I. Al-Obaide +4 more
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The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision‐making.
Naomi Beard +4 more
wiley +1 more source
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
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Major Adverse Cardiac Events with Ondansetron: A Systematic Review
Evidence base: 170 randomized trials, 23,421 adults, predominantly single‐dose IV ondansetron, mean follow‐up 20 days. Observed outcomes: Major adverse cardiac events were rare, no ventricular arrhythmias or torsades de pointes observed. Conclusion: Ondansetron was not associated with increased mortality or serious cardiac arrhythmias in adult ...
Michael Cristian Garcia +11 more
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Maternal Gestational Low‐Grade Inflammation and the Risk of Anorexia Nervosa in Daughters
ABSTRACT Objective Prenatal exposures have been suggested to have a programming effect on neural and metabolic development, which may affect the risk of eating disorders. We investigated the association between prospectively measured maternal gestational high‐sensitivity C‐reactive protein (hs‐CRP), an established inflammatory biomarker, and subsequent
Emma Saure +6 more
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