Results 51 to 60 of about 812,951 (357)

Drug Recall Monitoring and Trend Analysis: A Multidimensional Study [PDF]

open access: yesGlobal Journal on Quality and Safety in Healthcare, 2019
Background: Control of the quality of pharmaceutical and healthcare products in the market is mandatory to ensure the safety and efficacy of the delivered product to the final consumers. The United States Food and Drug Administration (FDA) is providing a
Mostafa E. Eissa
doaj   +1 more source

Development of a sensitive and rapid method for the measurement of total microbial activity using fluorescein diacetate (FDA) in a range of soils [PDF]

open access: yes, 2001
Fluorescein diacetate (FDA) hydrolysis is widely accepted as an accurate and simple method for measuring total microbial activity in a range of environmental samples, including soils.
Battin   +19 more
core   +1 more source

A comparative study of circulating tumor cell isolation and enumeration technologies in lung cancer

open access: yesMolecular Oncology, EarlyView.
Lung cancer cells were spiked into donor blood to evaluate the recovery rates of the following circulating tumor cell (CTC) enrichment technologies: CellMag™, EasySep™, RosetteSep™, Parsortix® PR1, and Parsortix® Prototype systems. Each method's advantages and disadvantages are described.
Volga M Saini   +11 more
wiley   +1 more source

Co-Pulsing FDA Radar [PDF]

open access: yesarXiv, 2022
Target localization based on frequency diverse array (FDA) radar has lately garnered significant research interest. A linear frequency offset (FO) across FDA antennas yields a range-angle dependent beampattern that allows for joint estimation of range and direction-of-arrival (DoA).
arxiv  

Considerations for the design and conduct of externally controlled trials for drug and biological products

open access: yesРеальная клиническая практика: данные и доказательства, 2023
This guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product.
A. S. Motrinchuk, D. Yu. Belousov
doaj   +1 more source

\u3ci\u3eUnited States v. Caronia\u3c/i\u3e: Off-Label Drug Promotion and First Amendment Balancing [PDF]

open access: yes, 2018
Off-label drug promotion is commonplace in the United States, but it is not without its dangers. While the Food, Drug, and Cosmetic Act does not explicitly ban off-label promotion, the Food & Drug Administration (FDA)— in order to protect consumers from ...
Rabinowitz, Daniel P.
core   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

open access: yes, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

Circulating tumor DNA (ctDNA) trajectories predict survival in trifluridine/tipiracil‐treated metastatic colorectal cancer patients

open access: yesMolecular Oncology, EarlyView.
The authors applied joint/mixed models that predict mortality of trifluridine/tipiracil‐treated metastatic colorectal cancer patients based on circulating tumor DNA (ctDNA) trajectories. Patients at high risk of death could be spared aggressive therapy with the prospect of a higher quality of life in their remaining lifetime, whereas patients with a ...
Matthias Unseld   +7 more
wiley   +1 more source

Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. [PDF]

open access: yes, 2008
BackgroundPrevious studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results.
Bacchetti, Peter   +2 more
core   +3 more sources

Inhibition of acyl‐CoA synthetase long‐chain isozymes decreases multiple myeloma cell proliferation and causes mitochondrial dysfunction

open access: yesMolecular Oncology, EarlyView.
Triacsin C inhibition of the acyl‐CoA synthetase long chain (ACSL) family decreases multiple myeloma cell survival, proliferation, mitochondrial respiration, and membrane potential. Made with Biorender.com. Multiple myeloma (MM) is an incurable cancer of plasma cells with a 5‐year survival rate of 59%.
Connor S. Murphy   +12 more
wiley   +1 more source

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