Results 141 to 150 of about 787,943 (334)

A NOVEL AND SIMPLE RULE OF THUMB FOR MULTIPLICITY CONTROL IN EQUIVALENCE TESTING USING TWO ONE-SIDED TESTS [PDF]

open access: yes, 2008
Equivalence testing is growing in use in scientific research outside of its traditional role in the drug approval process. Largely due to its ease of use and recommendation from the United States Food and Drug Administration guidance, the most common ...
Caffo, Brian S., Lauzon, Carolyn
core   +1 more source

Implementation of Drug‐Induced Rhabdomyolysis and Acute Kidney Injury in Microphysiological System

open access: yesAdvanced Functional Materials, EarlyView.
A modular Muscle–Kidney proximal tubule‐on‐a‐chip integrates 3D skeletal muscle and renal proximal tubule tissues to model drug‐induced rhabdomyolysis and acute kidney injury. The coculture system enables dynamic tissue interaction, functional contraction monitoring, and quantification of nephrotoxicity, revealing drug side effect‐induced metabolic ...
Jaesang Kim   +4 more
wiley   +1 more source

FDA Enforcement and the Constitution: The Validity of FDA Seizures under the Due Process and Just Compensation Clauses [PDF]

open access: yes, 2012
This paper explores the way in which enforcement actions by the Food and Drug Administration (FDA) interact with certain constitutional rights, and it queries whether the system does its most to protect those rights while preserving the public interest ...
Shane, Andrew L.
core  

Smart, Bio‐Inspired Polymers and Bio‐Based Molecules Modified by Zwitterionic Motifs to Design Next‐Generation Materials for Medical Applications

open access: yesAdvanced Functional Materials, EarlyView.
Bio‐based and (semi‐)synthetic zwitterion‐modified novel materials and fully synthetic next‐generation alternatives show the importance of material design for different biomedical applications. The zwitterionic character affects the physiochemical behavior of the material and deepens the understanding of chemical interaction mechanisms within the ...
Theresa M. Lutz   +3 more
wiley   +1 more source

Population structure analysis of Salmonella serovar Muenchen to redefine geno-serotyping using genome indexing approaches

open access: yesFrontiers in Microbiology
Accurate identification of Salmonella serovars for source attribution in foodborne illness outbreaks. Traditional serotyping, which relies on antigenic properties, continues to serve as gold standard; however, advances in whole-genome sequencing (WGS ...
Padmini Ramachandran   +6 more
doaj   +1 more source

Is Tobacco a Drug? Administrative Agencies as Common Law Courts [PDF]

open access: yes, 2014
Professor Cass Sunstein argues that the FDA has the authority to regulate tobacco products. He considers the text of the Federal Food, Drug, and Cosmetic Act, which supports the FDA assertion, and the context of its enactment, which argues against the ...
Sunstein, Cass Robert
core  

A Bespoke Programmable Interpenetrating Elastomer Network Composite Laryngeal Stent for Expedited Paediatric Laryngotracheal Reconstruction

open access: yesAdvanced Functional Materials, EarlyView.
A programmable interpenetrating double‐network architecture, created via 3D‐TIPS printing and resin infusion, synergistically combines thermoplastic and thermosetting elastomers to balance structural rigidity and surface softness—crucial for paediatric laryngeal stents.
Elizabeth F. Maughan   +14 more
wiley   +1 more source

Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS)

open access: yesJournal of Bone and Mineral Research, 2016
Xiaoyan Zhang   +7 more
semanticscholar   +1 more source

EMPIRICAL INVESTIGATION OF THE IMPACT OF THE 2007 RECALL ON THE DEMAND FOR PEANUT BUTTER BRANDS [PDF]

open access: yes
The US Food and Drug Administration confirmed in February 2007 that a major foodborne illness outbreak was caused by two peanut butter brands, Peter Pan and Great Value, manufactured by ConAgra Foods Inc. at its Sylvester, Georgia, processing plant. As a
Bakhtavoryan, Rafael   +2 more
core   +1 more source

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