Results 41 to 50 of about 244,160 (267)

A network of regulatory innovations to improve FDA quality assessments of human drug applications

International Journal of Pharmaceutics: X
A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA’s Center for Drug Evaluation and Research (
Russie Tran, Grace Fraser, Adam C. Fisher, Sau L. Lee, Ashley Boam, Stelios Tsinontides, Jennifer Maguire, Lawrence X. Yu, Susan Rosencrance, Steven Kozlowski, Don Henry   +10 more
doaj   +1 more source

Design and analysis strategies for robust microbiome ageing research

FEBS Letters, EarlyView.
The gut microbiome changes with age and associates with age‐related morbidity and mortality, establishing it as a potential biomarker and intervention target for ageing. Realising this potential requires methodological rigour, yet distinguishing biological signals from methodological artefacts remains challenging across cohorts. This review provides an
Mark Olenik, İsmail Güderer, Yi Wang, Tayyaba Alvi, Prasoon Pandey, Handan Melike Dönertaş   +5 more
wiley   +1 more source

Sample Size Determination for Food Sampling

Journal of Food Protection, 2023
Industry and public health agencies sample and test food products for various purposes related to food safety and quality. Methods of sample selection and sample size determination are important in designing an optimal sampling plan.
Shizhen S. Wang, Travis A. Canida, John D. Ihrie, Stuart J. Chirtel   +3 more
doaj   +1 more source

Investigating transcription factor dynamics in health and disease using FRAP

FEBS Letters, EarlyView.
FRAP analysis of GFP‐tagged transcription factors reveals how molecular mobility and target engagement change in response to drug treatment. By combining live‐cell imaging, quantitative model fitting, and statistical analysis, this approach uncovers transcription factor dynamics linked to disease mechanisms, providing a powerful framework for ...
Kannan Govindaraj, Carolina Vazquez Garzon, Jose Joaquin Velasco, Janine N. Post   +3 more
wiley   +1 more source

Developing predictive models for µ opioid receptor binding using machine learning and deep learning techniques

Experimental Biology and Medicine
Opioids exert their analgesic effect by binding to the µ opioid receptor (MOR), which initiates a downstream signaling pathway, eventually inhibiting pain transmission in the spinal cord.
Jie Liu, Jerry Li, Zoe Li, Fan Dong, Wenjing Guo, Weigong Ge, Tucker A. Patterson, Huixiao Hong   +7 more
doaj   +1 more source

Microbiome‐blood–brain barrier interactions in aging — mechanisms and therapeutic potential

FEBS Letters, EarlyView.
Aging reshapes the gut microbiome (↓SCFA‐producing commensals; ↑pro‐inflammatory outputs), shifting circulating metabolites (↓SCFAs; ↑LPS, ↑TMAO, ↑PAA) that act at the BBB to increase nonspecific transcytosis, alter transport, and promote astrocyte reactivity, heightening brain vulnerability.
Daniel Cuervo‐Zanatta, Hari Baskar Balasubramanian, Amir Pasokh, Marietta Zille   +3 more
wiley   +1 more source

Perceptions of nicotine harm among adults who use little cigars and cigarillos: A cross-sectional analysis of wave 7 of the Population Assessment of Tobacco and Health (PATH) Study 2022–2023

Tobacco Induced Diseases
Introduction Little is known about nicotine perceptions among people who use little cigars and cigarillos (LCCs). Nicotine perceptions may influence how people respond to changes in the tobacco marketplace, including changes that would result from ...
Amanda Fidalgo, Michael J. Halenar, Brittany Merson, Apoorva O. Rajan-Sharma   +3 more
doaj   +1 more source

A Comprehensive Evaluation of the Genetic Relatedness of Listeria monocytogenes Serotype 4b Variant Strains

Frontiers in Public Health, 2017
Recently, we have identified a link between four listeriosis incidents/outbreaks to a variant of Listeria monocytogenes (Lm) serotype 4b strains, 4bV.
Laurel S. Burall, Christopher J. Grim, Mark K. Mammel, Atin R. Datta   +3 more
doaj   +1 more source

The United States Food and Drugs Administration Approves a Generic Enoxaparin

Clinical and Applied Thrombosis/Hemostasis, 2010
The Food and Drug Administration (FDA) approved on July 23, 2010, the abbreviated new drug application (ANDA) by Sandoz Inc for a generic enoxaparin (Lovenox) as the FDA is satisfied with the active ingredient ‘‘sameness’’ and the interchangeability of Lovenox with this generic version. Regulatory authorities that consider low-molecular-weight heparins
openaire   +2 more sources

Structure‐forward targeting of claudins with synthetic binders

FEBS Letters, EarlyView.
Claudins form the paracellular barriers between epithelial and endothelial tissues at tight junctions and are targets for molecular binders with the goal of modulating barrier permeability. Claudin‐binding molecules are relevant in drug delivery or in altering claudin interactions with disease‐causing proteins.
Alex J. Vecchio
wiley   +1 more source