Results 21 to 30 of about 600,282 (299)

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
MORETTI, Ugo, De Ponti F., Sturkenboom, M, Sturkenboom, M.C.J.M. (Miriam), De Ponti, F, Behr, E.R. (Elijah), Koci A, Spina, E, Sturkenboom M, Ariola Koci, Poluzzi E, Spina E, Raschi, E. (Emanuel), Ponti, F. (Fabrizio) de, Ugo Moretti, Spina, E. (Edoardo), Poluzzi, E, POLUZZI, ELISABETTA, Koci, A. (Ariola), Behr ER, Koci, A, Elijah R. Behr, Elisabetta Poluzzi, Poluzzi, E. (Elisabetta), Sturkenboom, MCJM, Moretti, U. (Ugo), Fabrizio De Ponti, KOCI, ARIOLA, Moretti, U, Emanuel Raschi, Raschi, E, Miriam Sturkenboom, DE PONTI, FABRIZIO, Moretti U, RASCHI, EMANUEL, Behr, ER, Raschi E, Edoardo Spina   +37 more
core   +2 more sources

Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research

Frontiers in Medicine, 2017
Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration’s ...
Marc Kusinitz, Emily Braunstein, Carolyn A. Wilson   +2 more
doaj   +1 more source

A review of new drugs approved by the food and drug administration in 2022

Journal of Family Medicine and Primary Care, 2023
Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects.
Arjun Swaminathan, AE Vijayakumar, P Nikhithaa   +2 more
doaj   +1 more source

Alchemical Analysis of FDA Approved Drugs [PDF]

, 2023
Chemical space maps help visualize similarities within molecular sets. However, there are many different molecular similarity measures resulting in a confusing number of possible comparisons.
Markus, Orsi, Jean-Louis, Reymond, Daniel, Probst, Philippe, Schwaller   +3 more
core   +1 more source

Antibody affinity maturation and plasma IgA associate with clinical outcome in hospitalized COVID-19 patients

Nature Communications, 2021
SARS-CoV2 infection has been linked to a wide range of clinical severities and the immunopathology is still under intense scrutiny. Here, the authors uncover an association of antibody affinity maturation and plasma IgA levels with clinical outcome in ...
Juanjie Tang, Supriya Ravichandran, Youri Lee, Gabrielle Grubbs, Elizabeth M. Coyle, Laura Klenow, Hollie Genser, Hana Golding, Surender Khurana   +8 more
doaj   +1 more source

Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making

Реальная клиническая практика: данные и доказательства, 2023
In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions.
Ksenia S. Radaeva, M. V. Pchelintsev
doaj   +1 more source

FDA-approved compounds that show inhibition of osteosarcoma cell proliferation.

, 2018
FDA-approved compounds that show inhibition of osteosarcoma cell proliferation.
Melinda Broward (3233358), Douglas H. Thamm (311291), Joy M. Fulbright (5007380), Tyce Bruns (5007389), Tomoo Iwakuma (508731), Megan Ottomeyer (5007383), Alejandro Parrales (5007377), Anuradha Roy (630348), Scott J. Weir (2069470), Kathleen A. Neville (280552), Frank J. Shoenen (5007386), Peter McDonald (1580623)   +11 more
core   +1 more source

Pediatric Idiopathic Multicentric Castleman Disease Is Often Severe But Responsive to Siltuximab

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Idiopathic multicentric Castleman disease (iMCD) is a potentially fatal immunologic disorder marked by widespread lymphadenopathy and inflammation. Siltuximab, an interleukin‐6 (IL‐6) inhibitor, is the only FDA‐approved treatment for adult patients with iMCD.
Bridget Austin, Sheila K. Pierson, Kelley C. Dacus, Mateo Sarmiento Bustamante, Saishravan Shyamsundar, Larissa Borys, Kayla McHugh, Abiola Irvine, Yoojin Jo, Adam Bagg, Mary Jo Lechowicz, Daisy Alapat, Amy Chadburn, Megan S. Lim, Gordan Srkalovic, Frits van Rhee, David C. Fajgenbaum, Joshua D. Brandstadter   +17 more
wiley   +1 more source

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

GAA-UAM/scikit-fda: Functional Data Analysis in Python

, 2019
What's Changed Fix packaging. Fix FPCA grid implementation with regularization by @Ddelval in https://github.com/GAA-UAM/scikit-fda/pull/485 Hotfix: Correct the order of the parameters for the FPCA in Mahalanobis by @m5signorini in https://github.com ...
Castillo, Álvaro, Hong, Yujian, Torrecilla, José Luis, Ramos-Carreño, Carlos, Pérez Manso, Pablo, García Fernández, David, Marcos Manchón, Pablo, Petrunina, Elena, Hidalgo, Rafael, Hernando Bernabé, Amanda, Sánchez Romero, Álvaro, Carbajo Berrocal, Miguel, Serna, Diego, Suárez, Alberto, Rodríguez-Ponga Eyriès, Pedro Martín   +14 more
core   +1 more source