Results 141 to 150 of about 740,134 (361)

An Analysis of the U.S. Department of Agriculture's Proposal to Allow Irradiation of Meat [PDF]

Foodborne pathogens in the United States kill thousands and sicken millions each year, despite major efforts by federal agencies and industry to combat the problem.
Lutter, Randall
core   +1 more source

An Exploratory Study of Suboxone (Buprenorphine/ Naloxone) Film Splitting: Cutting Methods, Content Uniformity, and Stability [PDF]

, 2019
Suboxone films are U.S. Food and Drug Administration approved to treat opioid dependence. While the package insert states that films should not be cut, physicians often prescribe film fractions for treatment and tapering. There is no data to support this
Conn, Kelly, Corigliano, Anthony, DeAngelis, Michael J., Ferrara, Alexander S., Phillips, Elizabeth, Reindel, Kristin L., Zhao, Fang   +6 more
core   +1 more source

Through the looking glass: understanding non-inferiority [PDF]

, 2011
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United ...
BL Wiens, DB Petitti, EMA Committee for Medicinal Products for Human Use (CHMP), EMA Committee for Proprietary Medicinal Products (CPMP), J Wittes, Janet T Wittes, Jennifer Schumi, KK Teo, M Rothmann, MD Rothmann, N Mantel, R DerSimonian, R Temple, S Snappin, S Snappin, S Yusuf, SS Ellenberg, TR Fleming, TR Fleming, United States Food and Drug Administration   +19 more
core   +3 more sources

Novel (Q)SAR models for prediction of reversible and time-dependent inhibition of cytochrome P450 enzymes

Frontiers in Pharmacology
The 2020 FDA drug-drug interaction (DDI) guidance includes a consideration for metabolites with structural alerts for potential mechanism-based inhibition (MBI) and describes how this information may be used to determine whether in vitro studies need to ...
Sadegh Faramarzi, Arianna Bassan, Kevin P. Cross, Xinning Yang, Glenn J. Myatt, Donna A. Volpe, Lidiya Stavitskaya   +6 more
doaj   +1 more source

Nanofillers Reinforcing Biopolymer Composites for Sustainable Food Packaging Applications: A State‐of‐the‐Art Review

Advanced Functional Materials, EarlyView.
Biopolymers are sustainable, biodegradable alternatives to petroleum‐based plastics for food packaging. Its adoption is often limited by poor mechanical strength, barrier properties, and improved thermal stability through the incorporation of nanofillers.
Himakshi Baishya, Joydeep Dutta, Santosh Kumar   +2 more
wiley   +1 more source

Food Safety and Security: What Tragedy Teaches Us about Our 100-Year-Old Food Laws [PDF]

, 2007
The United States food safety system is antiquated and failing. The laws that form the foundation of our food protection and govern the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) were enacted over 100 years ...
DeWaal, Caroline S.
core   +1 more source

Bioinspired Shape Reconfigurable, Printable, and Conductive “E‐Skin” Patch with Robust Antibacterial Properties for Human Health Sensing

Advanced Functional Materials, EarlyView.
In this article, Hojin Kim, Sayan Deb Dutta, and co‐workers report a shape‐reconfigurable, 3D printable, and highly adhesive slime‐like ‘electronic skin’ or ‘E‐skin’ patch for human health sensing and tissue engineering applications. The dual reinforcement of hydrogel patch with carbon nanotubes (CNTs) and cellulose nanocrystals (CNCs) improve the ...
Hojin Kim, Sayan Deb Dutta, Myoung Joon Jeon, Jieun Lee, Hyeonseo Park, Youjin Seol, Ki‐Taek Lim   +6 more
wiley   +1 more source

The Unfinished Business of US Drug Safety Regulation [PDF]

, 2006
Posted with permission from FDLI ; Food and Drug Law Journal Various proposals have been advanced in response to recent problems with the safety of Food and Drug Administration (FDA)-approved drugs.
Evans, Barbara J., Flockhart, David A.
core  

United States Food and Drug Administration Approves Distribution of 10-Minute Flu Test to All Doctors [PDF]

, 2000
M. T. Osterholm
openalex   +1 more source

Embedded 3D‐Coaxial Bioprinting of Stenotic Brain Vessels with a Mechanically Enhanced Extracellular Matrix Bioink for Investigating Hemodynamic Force‐Induced Endothelial Responses

Advanced Functional Materials, EarlyView.
In this study, a physically enhanced vascular dECM bioink and used 3D‐coaxial bioprinting are developed to fabricate mature brain blood vessels for cerebral atherosclerosis research. This model demonstrates that vascular geometry‐induced hemodynamic changes trigger vascular inflammation, ensuring its potential for cerebrovascular research.
Wonbin Park, Min‐Ju Choi, Jae‐Seong Lee, Minjun Ahn, Wonil Han, Ge Gao, Dong‐Woo Cho, Byoung Soo Kim   +7 more
wiley   +1 more source