Results 61 to 70 of about 953,056 (326)

Transparency and Innuendo: An Alternative to Reactive Over-Disclosure [PDF]

open access: yes, 2006
Lassman examines the tension between transparency and other public health interests in the context of the FDA\u27s proposed Drug Watch web site. He argues that although the FDA proposal seeks to achieve a laudable goal--the prompt communication of ...
Lassman, Scott M.
core   +1 more source

Dual PI3K/AKT and CDK4/6 inhibition reveals selective sensitivity in an SHH medulloblastoma stem cell model

open access: yesMolecular Oncology, EarlyView.
Targeted therapy was evaluated in SHH medulloblastoma using neuroepithelial stem cell (NES) and tumor‐derived NES‐like (tNES) models in 2D monolayers and 3D spheroids. PI3K, AKT, and CDK4/6 inhibitors had minimal effects in NES but markedly reduced viability and growth and induced apoptosis in tNES cells, revealing distinct therapeutic vulnerabilities.
Monika Lukoseviciute   +4 more
wiley   +1 more source

Current regulatory approaches for accessing potential COVID-19 therapies

open access: yesJournal of Pharmaceutical Policy and Practice, 2020
This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials.
Vesa Halimi   +6 more
doaj   +1 more source

The Last Mile: DSCSA Solution Through Blockchain Technology: Drug Tracking, Tracing, and Verification at the Last Mile of the Pharmaceutical Supply Chain with BRUINchain

open access: yesBlockchain in Healthcare Today, 2020
Purpose: As part of the FDA’s DSCSA Pilot Project Program, UCLA and its solution partner, LedgerDomain (collectively referred to as the team hereafter), focused on building a complete, working blockchain-based system, BRUINchain, which would meet all the
William Chien   +6 more
doaj   +1 more source

Nudging the FDA [PDF]

open access: yes, 2014
[Excerpt] The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice.
Cohen, I. Glenn, Price, W. Nicholson, II
core   +1 more source

Evaluation of in vitro toxicity of common phytochemicals included in weight loss supplements using 1H NMR spectroscopy

open access: yesFEBS Open Bio, EarlyView.
We investigated the toxicity of 12 active compounds commonly found in herbal weight loss supplements (WLS) using human liver and colon cell models. Epigallocatechin‐3‐gallate was the only compound showing significant toxicity. Metabolic profiling revealed protein degradation, disrupted energy and lipid metabolism suggesting that the inclusion of EGCG ...
Emily C. Davies   +3 more
wiley   +1 more source

Ethical Issues in the Drug Approval Process [PDF]

open access: yes, 2013
The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for ...
McInnis, Meghan
core   +1 more source

The role of lipid metabolism in neuronal senescence

open access: yesFEBS Open Bio, EarlyView.
Disrupted lipid metabolism, through alterations in lipid species or lipid droplet accumulation, can drive neuronal senescence. However, lipid dyshomeostasis can also occur alongside neuronal senescence, further amplifying tissue damage. Delineating how lipid‐induced senescence emerges in neurons and glial cells, and how it contributes to ageing and ...
Dikaia Tsagkari   +2 more
wiley   +1 more source

Proteomic insights into dual-species biofilm formation of E. coli and E. faecalis on urinary catheters

open access: yesScientific Reports
Infections associated with urinary catheters are often caused by biofilms composed of various bacterial species that form on the catheters’ surfaces.
Kidon Sung   +5 more
doaj   +1 more source

The human experience with intravenous levodopa

open access: yesFrontiers in Pharmacology, 2016
Objective: To compile a comprehensive summary of published human experience with levodopa given intravenously, with a focus on information required by regulatory agencies.Background: While safe intravenous (IV) use of levodopa has been documented for ...
Shan H Siddiqi   +13 more
doaj   +1 more source

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