Results 91 to 100 of about 62,672 (281)

Learning signals of adverse drug-drug interactions from the unstructured text of electronic health records. [PDF]

, 2013
Drug-drug interactions (DDI) account for 30% of all adverse drug reactions, which are the fourth leading cause of death in the US. Current methods for post marketing surveillance primarily use spontaneous reporting systems for learning DDI signals and ...
Bauer-Mehren, Anna, Harpaz, Rave, Iyer, Srinivasan V, Lependu, Paea, Shah, Nigam H   +4 more
core   +5 more sources

A White Paper on Advancing Long‐Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation

Clinical Pharmacology &Therapeutics, EarlyView.
As use cases for long‐acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children—populations with a historical gap in the availability of interventions already approved for use in adults.
Moherndran Archary, Robert Bies, Osei Boateng, Rachel Daley, Pierre Gashema, Mili Karina, Emily Njuguna, Sharon Nachman, Nathaniel Nkrumah, Carolyne Odula, Andrew Owen, Ethel D. Weld, Prajith Venkatasubramanian, Adeniyi Olagunju, on behalf of the Community of Practice for Long‐acting Therapeutics for Maternal and Paediatric Health, Rana Abutaima, Dorothy Akongo, Abdulnaser Alsharaa, Moherndran Archary, Shakir Atoyebi, Benoit Bestgen, Robert Bies, Osei Boateng, Andrew Butler, Edmund Capparelli, Rachel Daley, Layla Davies, Joelle Dountio, Henry Enzama, Pierre Gashema, Katila George, Dan Hawcutt, Rene Holm, Patrick Gad Iradukunda, Elodie Jambert, Mili Karina, Linda Lewis, Grace Miheso, Sebastien Morin, Andrew Morrison, Sharon Nachman, Shadia Nakalema, Emily Njunga, Nathaniel Nkrumah, Carolyne Odula‐Obonyo, Brenda Okware, Adeniyi Olagunju, Andrew Owen, Martina Penazzato, Natella Rakhmanina, Mphako Brighton Ratlabyana, Rachel Scott, Kimberly Struble, Andre‐Marie Tchouatieu, Catherine Unsworth, Prajith Venkatasubramanian, Catriona Waitt, Ethel Weld, Janine Winterbottom, Leena Zino   +59 more
wiley   +1 more source

Pharmacovigilance update [Pharmacovigilance update]

, 2010
Main pharmacovigilance signals and alerts issued in 2009 are reviewed. Efalizumab was withdrawn from the market due to increased risks, including progressive multifocal leukoencephalopathy (PML) and questionable efficacy. New cases of PML are still being reported with rituximab and natalizumab.
Livio, F., Ivanyuk, A., Biollaz, J., Rothuizen, L., Buclin, T.   +4 more
openaire   +1 more source

Artificial Intelligence for Regulatory Evidence: A Systematic Document Analysis of European Medicines Agency Regulatory Advice and Public Reports

Clinical Pharmacology &Therapeutics, EarlyView.
Artificial intelligence (AI) is receiving increasing attention across the entire lifecycle of medicines, from early development to postauthorization use. While various AI tools have been developed in commercial and academic settings, the extent of their use in regulatory contexts within the European Union remains unknown.
Lucina‐May Nollen, Gerard J.P. van Westen, Gabriel Westman, Anna M.G. Pasmooij   +3 more
wiley   +1 more source

Application of real-time global media monitoring and ‘derived questions’ for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines

BMC Medicine, 2017
Background The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear.
Priya Bahri, Julianna Fogd, Daniel Morales, Xavier Kurz, on behalf of the ADVANCE consortium   +4 more
doaj   +1 more source

Long‐term cardiovascular outcomes of immune checkpoint inhibitor‐related myocarditis: A large single‐centre analysis

ESC Heart Failure, Volume 12, Issue 2, Page 1237-1245, April 2025.
Abstract Aims Immune checkpoint inhibitors (ICI) are the cornerstone of modern oncology; however, side effects such as ICI‐related myocarditis (irM) can be fatal. Recently, Bonaca proposed criteria for irM; however, it is unknown if they correlate well with cardiovascular (CV) ICI‐related adverse events.
Lorenzo Braghieri, Ahmad Gharaibeh, Lubika Nkashama, Abdelrahman Abushouk, Osama Abushawer, Amir Mehdizadeh‐Shrifi, Bianca Honnekeri, Cassandra Calabrese, Venu Menon, Pauline Funchain, Patrick Collier, Diego Sadler, Rohit Moudgil   +12 more
wiley   +1 more source

Adverse Drug Reaction Classification With Deep Neural Networks [PDF]

, 2016
We study the problem of detecting sentences describing adverse drug reactions (ADRs) and frame the problem as binary classification. We investigate different neural network (NN) architectures for ADR classification.
He, Yulan, Huynh, Trung, Rüger, Stefan, Willis, Alistair   +3 more
core   +1 more source

Stiripentol: Unpublished results from the first phase 2 clinical trial in Lennox–Gastaut syndrome conducted in the early 1990s

Epilepsia, EarlyView.
Abstract Objective This study was undertaken to present the results of an exploratory phase 2 trial of stiripentol in Lennox–Gastaut syndrome (LGS). Methods This exploratory single‐blind, single‐arm, nonrandomized sequential‐period phase 2 study was conducted at four centers in France between January 1989 and August 1993.
Stéphane Auvin, Benjamin Serraz, Jérémie Lespinasse, Laurent Chancharme   +3 more
wiley   +1 more source

Strengthening Pharmacovigilance System to Capture Safety Data from HIV Clients on ART in Tanzania: Identification of Gaps in Safety Reporting System [PDF]

, 2013
In Tanzania, pharmacovigilance system is implemented by Tanzania Food and Drugs Authority (TFDA) that monitors drug use countrywide. TFDA is the main national custodian for recording, analyzing and disseminating safety information that is generated ...
Baraka, Vito, Fakih, Bakar, Francis, Filbert, Kabanywanyi, Abdulnoor, Maiga, Deo, Makunde, Williams, Massaga, Julius, Mmbando, Bruno, Msovela, Judith, Mushi, Adiel   +9 more
core  

Adverse outcomes among pregnant women with COVID‐19 according to hospitalization status: A prospective individual participant data meta‐analysis in Europe and North America

International Journal of Gynecology &Obstetrics, EarlyView.
Abstract Background Understanding the varied impact of COVID‐19 severity on pregnancy outcomes is crucial for informed clinical management and targeted interventions. Objective To evaluate the impact of COVID‐19 on pregnancy outcomes, distinguishing between pregnant women managed in primary care and those requiring hospitalization.
Odette de Bruin, Emeline Maisonneuve, Eimir Hurley, Hedvig M. E. Nordeng, Anick Bérard, Odile Sheehy, Padma Kaul, Mayura U. Shinde, Austin Cosgrove, Jennifer G. Lyons, Elizabeth Messenger‐Jones, Maria E. Kempner, Sengwee Toh, Wei Hua, José J. Hernández‐Muñoz, Leyla Sahin, Carolyn E. Cesta, David Hägg, Rosa Gini, Olga Paoletti, Beatriz Poblador‐Plou, Sue Jordan, Clara L. Rodríguez‐Bernal, Francisco Sánchez‐Sáez, Régis Lassalle, Marie‐Agnès Bernard, Fariba Ahmadizar, Guillaume Favre, Alice Panchaud, Kitty W. M. Bloemenkamp, Kelly Plueschke, Corinne de Vries, Satu J. Siiskonen, Miriam C. J. M. Sturkenboom, on behalf of the CONSIGN Collaboration Group, Benjamin P. Geisler, Mark Walker, Steven Hawken, Sasha Bernatsky, Sherif Eltonsy, Emma Hoffman, Andrew B. Petrone, Jolene Mosley, Jenice Ko, Claudia Bartolini, Giuseppe Roberto, Giorgio Limoncella, Anna Girardi, Giulia Hyeraci, Antonio Gimeno‐Miguel, Jonás Carmona‐Pírez, Antonio Poncel‐Falcó, Aida Moreno‐Juste, Alexandra Prados‐Torres, Daniel Thayer, Ian Farr, Saira Ahmed, Ieuan Scanlon, Gabriel Sanfélix‐Gimeno, Isabel Hurtado, Anibal Garcia‐Sempere, Salvador Peiro, Jérémy Jové, Dunia Sakr, Cécile Droz‐Perroteau, Ema Alsina, David Baud, Hilde M. Engjom, Judit Riera‐Arnau, Mònica Sabaté Gallego, Elena Ballarín Alins, Cristina Aguilera Martin, Melissa Kampman, Celline Brasil   +73 more
wiley   +1 more source