Results 111 to 120 of about 373,154 (280)

Principles of Use of Biostatistics in Research

open access: green, 2014
Veena Manja, Satyan Lakshminrusimha
openalex   +1 more source

Biomarkers of Drug‐Induced Kidney Injury: Use in Clinical Trials and Recent Examples of Impact on Drug Development

open access: yesClinical 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

Editorial: Bioinformatics and Biostatistics Applications in Tobacco Smoking Research [PDF]

open access: gold, 2018
Mohammed A. I. Al-Obaide   +4 more
openalex   +1 more source

Capability Development in the European Medicines Regulatory Network—A European Learning Needs Analysis and Survey Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
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

open access: yesClinical 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

Biostatistics in Agriculture - Modern Agricultural Statistics Looking at the Roots of Agricultural Data Analysis -

open access: diamond, 2023
Nobuhiro Minaka   +8 more
openalex   +2 more sources

Major Adverse Cardiac Events with Ondansetron: A Systematic Review

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
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
wiley   +1 more source

Maternal Gestational Low‐Grade Inflammation and the Risk of Anorexia Nervosa in Daughters

open access: yesInternational Journal of Eating Disorders, EarlyView.
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
wiley   +1 more source

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