Results 111 to 120 of about 7,897,516 (385)

Public feedback to FDA on regulatory considerations for AI in drug manufacturing

AAPS Open
FDA’s Center for Drug Evaluation and Research (CDER) established the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to establish a regulatory framework to support the adoption of advanced manufacturing technologies that ...
Jayanti Das, Thomas F. O’Connor, Adam C. Fisher, Manuel Osorio, Johnny Lam, Riley C. Myers   +5 more
doaj   +1 more source

Evaluation of optic neuritis following human papillomavirus vaccination

Human Vaccines & Immunotherapeutics, 2017
To assess the relationship between human papillomavirus (HPV) vaccination and occurrence of optic neuritis (ON) and to evaluate a claims-based algorithm for identification of ON. Females of 9–26 year olds in the HealthCore's Integrated Research Database (
Gayathri Sridhar, Fang Tian, Richard Forshee, Martin Kulldorff, Nandini Selvam, Andrea Sutherland, Wilson Bryan, Samuel Barone, Lei Xu, Hector S. Izurieta   +9 more
doaj   +1 more source

Extracting adverse drug reactions and their context using sequence labelling ensembles in TAC2017 [PDF]

Text Analytics Conference 2017, 2019
Adverse drug reactions (ADRs) are unwanted or harmful effects experienced after the administration of a certain drug or a combination of drugs, presenting a challenge for drug development and drug administration. In this paper, we present a set of taggers for extracting adverse drug reactions and related entities, including factors, severity, negations,
arxiv  

Diffusion of treatment in social networks and mass drug administration

Nature Communications, 2017
Information, behaviors, and technologies spread when people interact. Understanding these interactions is critical for achieving the greatest diffusion of public interventions.
Goylette F. Chami, A. Kontoleon, Erwin Bulte, A. Fenwick, N. Kabatereine, E. Tukahebwa, D. Dunne   +6 more
semanticscholar   +1 more source

Cellular liquid biopsy provides unique chances for disease monitoring, preclinical model generation and therapy adjustment in rare salivary gland cancer patients

Molecular Oncology, EarlyView.
We quantified and cultured circulating tumor cells (CTCs) of 62 patients with various cancer types and generated CTC‐derived tumoroid models from two salivary gland cancer patients. Cellular liquid biopsy‐derived information enabled molecular genetic assessment of systemic disease heterogeneity and functional testing for therapy selection in both ...
Nataša Stojanović Gužvić, Florian Lüke, Steffi Treitschke, Andrea Coluccio, Martin Hoffmann, Giancarlo Feliciello, Adithi Ravikumar Varadarajan, Xin Lu, Kathrin Weidele, Catherine Botteron, Silvia Materna–Reichelt, Felix Keil, Katja Evert, Florian Weber, Thomas Schamberger, Michael Althammer, Jirka Grosse, Dirk Hellwig, Christian Schulz, Stephan Seitz, Peter Ugocsai, Anke Schlenska‐Lange, Roman Mayr, Ulrich Kaiser, Wolfgang Dietmaier, Bernhard Polzer, Jens Warfsmann, Kamran Honarnejad, Tobias Pukrop, Daniel Heudobler, Christoph A. Klein, Christian Werno   +31 more
wiley   +1 more source

Effects of oral, smoked, and vaporized cannabis on endocrine pathways related to appetite and metabolism: a randomized, double-blind, placebo-controlled, human laboratory study. [PDF]

, 2020
As perspectives on cannabis continue to shift, understanding the physiological and behavioral effects of cannabis use is of paramount importance. Previous data suggest that cannabis use influences food intake, appetite, and metabolism, yet human research
Abulseoud, Osama A, Farokhnia, Mehdi, Huestis, Marilyn A, Leggio, Lorenzo, McDiarmid, Gray R, Munjal, Vikas, Newmeyer, Matthew N   +6 more
core   +1 more source

REP: Predicting the Time-Course of Drug Sensitivity [PDF]

arXiv, 2019
The biological processes involved in a drug's mechanisms of action are oftentimes dynamic, complex and difficult to discern. Time-course gene expression data is a rich source of information that can be used to unravel these complex processes, identify biomarkers of drug sensitivity and predict the response to a drug.
arxiv  

US Food and Drug Administration

The Palgrave Encyclopedia of Interest Groups, Lobbying and Public Affairs, 2021
Barbara Desanto
semanticscholar   +1 more source

Combined spatially resolved metabolomics and spatial transcriptomics reveal the mechanism of RACK1‐mediated fatty acid synthesis

Molecular Oncology, EarlyView.
The authors analyzed the spatial distributions of gene and metabolite profiles in cervical cancer through spatial transcriptomic and spatially resolved metabolomic techniques. Pivotal genes and metabolites within these cases were then identified and validated.
Lixiu Xu, Jinqiu Li, Junqi Ma, Ayshamgul Hasim   +3 more
wiley   +1 more source

Therapy of pancreatic cancer via an EphA2 receptor-targeted delivery of gemcitabine. [PDF]

, 2016
First line treatment for pancreatic cancer consists of surgical resection, if possible, and a subsequent course of chemotherapy using the nucleoside analogue gemcitabine.
Barile, Elisa, Das, Swadesh K, De, Surya K, Emdad, Luni, Fisher, Paul B, Morvaridi, Susan Kharagh, Pandol, Stephen J, Pellecchia, Maurizio, Quinn, Bridget A, Sarkar, Devanand, Stebbins, John L, Wang, Si   +11 more
core   +2 more sources