Results 121 to 130 of about 1,107,201 (376)

Regulatory controls for direct-to-consumer genetic tests: a case study on how the FDA exercised its authority

open access: yesNew Genetics and Society, 2017
In February 2015, 23andMe received clearance from the United States Food and Drug Administration (FDA) for a carrier status test for a gene linked to Bloom syndrome.
Margaret Curnutte
doaj   +1 more source

Development of Luciferase Immunoprecipitation Systems (LIPS) Assay to Detect IgG Antibodies against Human Respiratory Syncytial Virus G-Glycoprotein

open access: yesVaccines, 2019
Respiratory syncytial virus (RSV) causes severe lower respiratory tract disease in infants and the elderly. Although there is no licensed vaccine, RSV-F and -G glycoproteins are targets for vaccine development and therapeutics. We developed an assay that
Roberta Lynne Crim   +5 more
doaj   +1 more source

Preferences for post‐traumatic osteoarthritis prevention strategies in individuals with anterior cruciate ligament injury

open access: yesArthritis Care &Research, Accepted Article.
Objectives There is growing interest in evaluating new strategies to delay or prevent post‐traumatic osteoarthritis (PTOA) in individuals who have sustained anterior cruciate ligament (ACL) injury. This study sought to determine characteristics of potential treatments that are acceptable to patients with ACL injury.
Kevin Kennedy   +9 more
wiley   +1 more source

Bridging organ transcriptomics for advancing multiple organ toxicity assessment with a generative AI approach

open access: yesnpj Digital Medicine
Translational research in toxicology has significantly benefited from transcriptomic profiling, particularly in drug safety. However, its application has predominantly focused on limited organs, notably the liver, due to resource constraints.
Ting Li, Xi Chen, Weida Tong
doaj   +1 more source

Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis Under the Sherman Act and the Noerr-Pennington Doctrine [PDF]

open access: yes, 2017
The Hatch-Waxman Act of 1984 regulates approval by the Food and Drug Administration (“FDA”) of generic counterparts to patented drugs. In a series of recent cases, large pharmaceutical companies have been accused of exploiting Hatch-Waxman in violation ...
Resek, John F., Ph.D.
core   +1 more source

Temporal Trends in and Associations With Nonsteroidal Anti‐inflammatory Drug Prescription in Adult and Pediatric Patients With Inflammatory Bowel Disease

open access: yesArthritis Care &Research, EarlyView.
Objective Recent inflammatory bowel disease (IBD) treatment guidelines have recommended against nonsteroidal anti‐inflammatory drug (NSAID) use despite prevalent musculoskeletal symptoms and opioid overuse in this population. Given the discordance between changing national guidelines and potential clinical utility, we sought to assess national temporal
Adam S. Mayer   +5 more
wiley   +1 more source

Bioactivity of nanosilver in Caenorhabditis elegans: Effects of size, coat, and shape

open access: yesToxicology Reports, 2014
The in vivo toxicity to eukaryotes of nanosilver (AgNP) spheres and plates in two sizes each was assessed using the simple model organism Caenorhabditis elegans.
Piper Reid Hunt   +6 more
doaj   +1 more source

Functional Regression [PDF]

open access: yes, 2014
Functional data analysis (FDA) involves the analysis of data whose ideal units of observation are functions defined on some continuous domain, and the observed data consist of a sample of functions taken from some population, sampled on a discrete grid ...
Morris, Jeffrey S.
core  

Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Belimumab in Pediatric Patients with Systemic Lupus Erythematosus: A Multicenter, Open‐Label Trial

open access: yesArthritis Care &Research, Accepted Article.
Objective This study aimed to characterize the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of subcutaneous belimumab in pediatric patients with active systemic lupus erythematosus (SLE) receiving standard therapy. Methods This single‐arm, multicenter, open‐label trial (GSK study 200908; NCT04179032) used three‐weight‐band ...
Hermine I. Brunner   +14 more
wiley   +1 more source

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