Works matching IS 26740869 AND DT 2024

Results: 70

Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1497116

By:

Mestres, Jordi

Publication type:

Article

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the "ilmiovaccinoCOVID19 collaborating group".

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1363086

By:

Luxi, Nicoletta;
Bellitto, Chiara;
Ciccimarra, Francesco;
Cappello, Emiliano;
L'Abbate, Luca;
Bonaso, Marco;
Ajolfi, Chiara;
Baldo, Paolo;
Bonaiuti, Roberto;
Costantino, Claudio;
De Sarro, Giovambattista;
Di Mauro, Cristina;
Fava, Giuseppina;
Ferri, Marina;
Firenze, Alberto;
Furci, Fabiana;
Gallelli, Luca;
Leonardi, Luca;
Negri, Giovanna;
Pieraccini, Fabio

Publication type:

Article

Measurement error and bias in real-world oncology endpoints when constructing external control arms.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1423493

By:

Ackerman, Benjamin;
Gan, Ryan W.;
Meyer, Craig S.;
Wang, Jocelyn R.;
Zhang, Youyi;
Hayden, Jennifer;
Mahoney, Grace;
Lund, Jennifer L.;
Weberpals, Janick;
Schneeweiss, Sebastian;
Roose, James;
Siddique, Juned;
Nadeem, Omar;
Giri, Smith;
Stürmer, Til;
Ailawadhi, Sikander;
Batavia, Ashita S.;
Sarsour, Khaled

Publication type:

Article

External comparator studies and the joint application of the estimand and target trial emulation frameworks.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1409102

By:

Rippin, Gerd;
Sanz, Héctor

Publication type:

Article

Regulation 2017/745 on medical devices, two major innovations: 1) the physiological action of devices consisting of natural materials such as vegetal matrices; 2) the chemical-physical-mechanical action of devices made of "substances", which as such are artificial derivatives

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1389406

By:

Marletta, Marcella

Publication type:

Article

Application of the target trial emulation framework to external comparator studies.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1380568

By:

Arnold, Kellyn;
Antunes, Luis;
Coles, Briana;
Lee, Hopin

Publication type:

Article

External comparators and estimands.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1332040

By:

Rippin, Gerd

Publication type:

Article

Safety of corticosteroid therapy in sarcoidosis treatment.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1319931

By:

Di Marco Berardino, Alessandro;
Mei, Federico;
Zuccatosta, Lina

Publication type:

Article

A review of the prescribing culture of anti-depressants across government districts in Northern Ireland.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1303572

By:

Ruddock, Mark W.;
Watt, Joanne;
Kurth, Mary Jo;
Lamont, John V.;
Mooney, Laura;
Fitzgerald, Peter

Publication type:

Article

Promising treatment biomarkers in asthma.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1291471

By:

Bonnesen, Barbara;
Jensen, Jens-Ulrik S.;
Mathioudakis, Alexander G.;
Corlateanu, Alexandru;
Sivapalan, Pradeesh

Publication type:

Article

Drug target, class level, and PathFX pathway information share utility for machine learning prediction of common drug-induced side effects.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1287535

By:

Liu, Han Jie;
Wilson, Jennifer L.

Publication type:

Article

Identification of small cell lung cancer patients who are at risk of developing common serious adverse event groups with machine learning.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1267623

By:

Wanika, Linda;
Evans, Neil D.;
Chappell, Michael J.

Publication type:

Article

Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1257732

By:

Hammad, Tarek A.;
Afsar, Salman;
Le-Louet, Herve;
Kugener, Veronique F.

Publication type:

Article

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1445519

By:

Meloni, Marisa;
De Servi, Barbara;
Carriero, Francesco;
Simon O'Brien, Emmanuelle;
Houamel, Dounia;
Deruelle, Philippe;
Castagné, Vincent

Publication type:

Article

Corrigendum: An industry perspective on the use of machine learning in drug and vaccine safety.

Published in:

2024

By:

Painter, Jeffery L.;
Kassekert, Raymond;
Bate, Andrew

Publication type:

Correction Notice

The risk of preterm labor after COVID-19 vaccination before and during pregnancy.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1235051

By:

de Feijter, M.;
Vissers, L. C. M.;
Davidson, L.;
Kant, A. C.;
Woestenberg, P. J.

Publication type:

Article

Mucoadhesive polymers in substance-based medical devices: functional ingredients or what else?

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1227763

By:

Vigani, Barbara;
Rossi, Silvia;
Sandri, Giuseppina;
Bonferoni, Maria Cristina;
Caramella, Carla M.

Publication type:

Article

Editorial: Substance-based medical devices for human health: a challenge of efficacy, safety, and sustainability.

Published in:

2024

By:

Mugelli, Alessandro;
Tamargo, Juan

Publication type:

Editorial

Evaluation of cardiovascular toxicity of the atezolizumab and bevacizumab combination.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1213771

By:

Niimura, Takahiro;
Goda, Mitsuhiro;
Miyata, Koji;
Matsumoto, Jun;
Yoshioka, Toshihiko;
Hamano, Hirofumi;
Aizawa, Fuka;
Yagi, Kenta;
Izawa-Ishizawa, Yuki;
Zamami, Yoshito;
Ishizawa, Keisuke

Publication type:

Article

Signal management and risk minimization strategy: a case study on obinutuzumab and non-overt disseminated intravascular coagulation.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1194683

By:

Valdiserra, Giulia;
Mores, Nadia;
Rocchi, Rosalba Elisabetta;
Sottosanti, Laura;
Felicetti, Patrizia;
Marchione, Pasquale;
Laurenti, Luca;
Fresa, Alberto;
Bucaneve, Giampaolo;
Cappello, Emiliano;
Bonaso, Marco;
Ferraro, Sara;
Convertino, Irma;
Tuccori, Marco

Publication type:

Article

Aspects to consider in causality assessment of safety signals: broadening the thought process.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1193413

By:

Hammad, Tarek A.;
Afsar, Salman;
McAvoy, Laura B.;
Le Louet, Hervé

Publication type:

Article

Editorial: Computational methods and systems to support decision making in pharmacovigilance.

Published in:

2024

By:

Botsis, Taxiarchis;
Ball, Robert;
Norén, G. Niklas

Publication type:

Editorial

Specialty grand challenge editorial innovative approaches for pharmacoepidemiologic research in pregnancy: Shifting the paradigm of Thalidomide's impact on pregnant women.

Published in:

2024

By:

Gerbier, Eva;
Panchaud, Alice

Publication type:

Editorial

Datamama, bringing pregnancy research into the future: design, development, and evaluation of a citizen science pregnancy mobile application.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1187023

By:

Gerbier, Eva;
Vial, Yvan;
Puder, Jardena;
Le Dizès, Olivier;
Andrey, Magali;
Arhab, Amar;
Horsch, Antje;
Avignon, Valérie;
Fort, Déborah;
Deforges, Camille;
Fischer Fumeaux, Céline J.;
Henriot, Isabelle;
Pereira Goncalves, Diana Pinto;
Pomar, Léo;
Favre, Guillaume;
Damnon, Françoise;
Legardeur, Hélène;
Mayor, Gaëlle;
Ceulemans, Michael;
Budry, Nohan

Publication type:

Article

Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1445998

By:

Hammad, Tarek A.;
Davis, Simon;
Afsar, Salman

Publication type:

Article

Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1166963

By:

Sillis, Laure;
Foulon, Veerle;
Allegaert, Karel;
Bogaerts, Annick;
De Vos, Maarten;
Hompes, Titia;
Smits, Anne;
Van Calsteren, Kristel;
Verbakel, Jan Y.;
Ceulemans, Michael

Publication type:

Article

Safety and efficacy of substance-based medical devices: Design of an in vitro barrier effect test.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1124873

By:

Bassetto, Rebecca;
Perin, Stefano;
Amadio, Emanuele;
Zanatta, Samuele;
Nenzioni, Davide;
Bertin, Walter

Publication type:

Article

Natural language processing for automated triage and prioritization of individual case safety reports for case-by-case assessment.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1120135

By:

Lieber, Thomas;
Gosselt, Helen R.;
Kools, Pelle C.;
Kruijssen, Okko C.;
Van Lierop, Stijn N. C.;
Härmark, Linda;
Van Hunsel, Florence P. A. M.

Publication type:

Article

Gastrointestinal functional disorders can benefit from the use of medical devices made of substances.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1119353

By:

Savarino, Vincenzo;
Marabotto, Elisa;
Zentilin, Patrizia;
Furnari, Manuele;
Bodini, Giorgia;
Giovanni Giannini, Edoardo;
Vincenzo Savarino, Edoardo

Publication type:

Article

Balancing the evidence: An update on analgesic use in rheumatic and musculoskeletal diseases.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1117674

By:

Huang, Yun-Ting;
McCarthy, Craig;
Jani, Meghna

Publication type:

Article

An industry perspective on the use of machine learning in drug and vaccine safety.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1110498

By:

Painter, Jeffery L.;
Kassekert, Raymond;
Bate, Andrew

Publication type:

Article

A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2022.992359

By:

Cioeta, Roberto;
Cossu, Andrea;
Giovagnoni, Emiliano;
Rigoni, Marta;
Muti, Paola

Publication type:

Article

Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2022.1089965

By:

Manellari, Sara;
Leone, Maria Grazia;
Casiraghi, Antonella;
Gennari, Chiara Grazia Milena;
Minghetti, Paola

Publication type:

Article

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2022.1071620

By:

Rasi, Guido;
Mugelli, Alessandro

Publication type:

Article

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1477516

By:

Hammad, Tarek A.;
Sabrdaran, Sasan;
Heim, Jean-Marie

Publication type:

Article

Adverse events in rheumatoid arthritis patients under antimalarial treatment—Is there cardiovascular compromise?

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2022.1044696

By:

Santos-Moreno, Pedro;
Ibatá, Linda;
Martínez, Susan;
Rodríguez-Vargas, Gabriel-Santiago;
Villarreal, Laura;
Rodríguez, Pedro;
Rivero, Wilberto;
Rodríguez-Florido, Fernando;
Rojas-Villarraga, Adriana

Publication type:

Article

An open-source platform integrating emerging data sources to support multi-modal active pharmacovigilance.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2022.1016042

By:

Dimitriadis, Vlasios K.;
Dimitsaki, Stella;
Chytas, Achilleas;
Gavriilidis, George I.;
Kakalou, Christine;
Bonotis, Panos;
Natsiavas, Pantelis

Publication type:

Article

Deprescribing as a strategy for improving safety of medicines in older people: Clinical and regulatory perspective.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2022.1011701

By:

Crisafulli, Salvatore;
Poluzzi, Elisabetta;
Lunghi, Carlotta;
Di Francesco, Vincenzo;
Pellizzari, Luca;
Pasina, Luca;
Elli, Chiara;
Trotta, Francesco;
Cangini, Agnese;
Trevisan, Caterina;
Zazzara, Maria Beatrice;
Onder, Graziano;
Trifirò, Gianluca

Publication type:

Article

Assessing the performance of large language models in literature screening for pharmacovigilance: a comparative study.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1379260

By:

Li, Dan;
Wu, Leihong;
Zhang, Mingfeng;
Shpyleva, Svitlana;
Lin, Ying-Chi;
Huang, Ho-Yin;
Li, Ting;
Xu, Joshua

Publication type:

Article

Editorial: Traditional and innovative approaches for signal detection.

Published in:

2024

By:

Tuccori, Marco;
Bate, Andrew;
Moretti, Ugo;
Trifirò, Gianluca

Publication type:

Editorial

Editorial: Treatment of comorbidities of asthma and its safety.

Published in:

2024

By:

Covantsev, Serghei;
Corlateanu, Alexandru

Publication type:

Editorial

Machine learning analysis of patients' perceptions towards generic medication in Greece: a survey-based study.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1363794

By:

Kassandros, Konstantinos;
Saranti, Evridiki;
Misailidou, Evropi;
Tsiggou, Theodora-Aiketerini;
Sissiou, Eleftheria;
Kolios, George;
Constantinides, Theodoros;
Kontogiorgis, Christos

Publication type:

Article

Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data—a ConcePTION project.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1187888

By:

van Rijt-Weetink, Yrea R. J.;
Chamani, Khoezik;
Egberts, Antoine C. G.;
van Hunsel, Florence P. A. M.;
Lewis, David J.;
Yates, Laura M.;
Winterfeld, Ursula;
van Puijenbroek, Eugène P.

Publication type:

Article

Menstrual disorders following COVID-19 vaccination: a review using a systematic search.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1338466

By:

Smaardijk, Veerle R.;
Jajou, Rana;
Kant, Agnes;
van Hunsel, Florence P. A. M.

Publication type:

Article

Progressive multifocal leukoencephalopathy reports in rheumatoid arthritis concerning different treatment patterns-an exploratory assessment using the food and drug administration adverse event reporting system.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1334468

By:

Honma, Takeshi;
Onda, Kenji;
Masuyama, Koichi

Publication type:

Article

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1323057

By:

Cutroneo, Paola Maria;
Sartori, Daniele;
Tuccori, Marco;
Crisafulli, Salvatore;
Battini, Vera;
Carnovale, Carla;
Rafaniello, Concetta;
Capuano, Annalisa;
Poluzzi, Elisabetta;
Moretti, Ugo;
Raschi, Emanuel

Publication type:

Article

External Comparator Cohort studies - clarification of terminology.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2023.1321894

By:

Rippin, Gerd;
Largent, Joan;
Hoogendoorn, Wilhelmina Elisabeth;
Sanz, Héctor;
Bosco, Jaclyn;
Mack, Christina

Publication type:

Article

Artificial intelligence for optimizing benefits and minimizing risks of pharmacological therapies: challenges and opportunities.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1356405

By:

Crisafulli, Salvatore;
Ciccimarra, Francesco;
Bellitto, Chiara;
Carollo, Massimo;
Carrara, Elena;
Stagi, Lisa;
Triola, Roberto;
Capuano, Annalisa;
Chiamulera, Cristiano;
Moretti, Ugo;
Santoro, Eugenio;
Tozzi, Alberto Eugenio;
Recchia, Giuseppe;
Trifirò, Gianluca

Publication type:

Article

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology.

Published in:

2024

By:

Zou, Wen;
Natsiavas, Pantelis;
Gottlieb, Assaf

Publication type:

Editorial

Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review.

Published in:

Frontiers in Drug Safety & Regulation, 2024, p. 1, doi. 10.3389/fdsfr.2024.1428831

By:

Kim, Julie V.;
Davis, Sharon E.;
Matheny, Michael E.;
Smith, Joshua C.

Publication type:

Article