Results 51 to 60 of about 48,983 (212)

PHARMACOVIGILANCE IN GERIATRICS [PDF]

International Research Journal of Pharmacy, 2014
Pharmacovigilance has gained significant importance with increased number of drugs molecules entering the market and the increase in the number of drug recalls due to the involvement of high health risks incident. It has become a critical phase in clinical development program to improve patient care and safety in relation to the use of medicines and ...
Vijendra R, Manasa S, Chandrasekhar H R, Kiran Nagaraju   +3 more
openaire   +1 more source

Academic development of advanced therapies—How to foster their future in the clinic

British Journal of Clinical Pharmacology, Volume 91, Issue 4, Page 1080-1083, April 2025.
Ana Hidalgo‐Simon, Caroline Pothet, Emer Cooke, Steffen Thirstrup   +3 more
wiley   +1 more source

Model‐Informed Drug Development Applications and Opportunities in mRNA‐LNP Therapeutics

Clinical Pharmacology &Therapeutics, EarlyView.
The utilization of lipid nanoparticles (LNP) for encapsulating mRNA has revolutionized the field of therapeutics, enabling the rapid development of COVID‐19 vaccines and cancer vaccines. However, the clinical development of mRNA‐LNP therapeutics faces numerous challenges due to their complex mechanisms of action and limited clinical experience.
Jiawei Zhou, Rohit Rao, Monica E. Shapiro, Nessy Tania, Cody Herron, Cynthia J. Musante, Jim H. Hughes   +6 more
wiley   +1 more source

Comorbidities of patients in tiotropium clinical trials : comparison with observational studies of patients with chronic obstructive pulmonary disease [PDF]

, 2015
Acknowledgments The authors are fully responsible for all content and editorial decisions made, were involved at all stages of manuscript development, and have approved the final version for publication.
Celli, Bartolome, Metzdorf, Norbert, Miravitlles, Marc, Price, David, Rabe, Klaus F, Schmidt, Hendrik   +5 more
core   +1 more source

Optimizing Patient Registries for Regulatory Decision Making ‐ Key Learnings From an HMA/EMA Multistakeholder Workshop

Clinical Pharmacology &Therapeutics, EarlyView.
The Joint Heads of Medicines Agencies and European Medicines Agency's (HMA/EMA) big data initiative paves the way for better integration of real‐world data, including data from patient registries, into regulatory decisions on medicines. This article focuses on the outcome of a two‐day multistakeholder workshop organized by EMA in 2024, which explored ...
Kelly Plueschke, Carla Jonker, Hanna Kankanen, Thorsten Vetter, Bruno Sepodes, Lutz Naehrlich, Jan Hillert, Gracy Crane, Sabine Straus, Paolo Foggi, Simona Martin, Christina Kyriakopoulou, Peter Mol, Francesca Day, Kieran Breen, Neil Bennett, Mencia de Lemus Belmonte, Simon Bennett, Patrice Verpillat, Kit C. B. Roes, Ana Cochino, Franz Schaefer, Jesús María Hernández‐Rivas, Patricia McGettigan, Peter Arlett   +24 more
wiley   +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

Hospital doctors' views and concerns about pharmacovigilance [PDF]

, 2015
Purpose: The aim of the study was to evaluate the opinions and concerns of hospital doctors about adverse drug reactions (ADRs) and pharmacovigilance.
Arnau de Bolós, Josep M., Castañeda, P. F., Esterlich, E., Pedrós, Consuelo, Quijada Manuitt, M. Angeles, Quintana, B., Simón, C. P., Vallano Ferraz, Antonio   +7 more
core   +2 more sources

A Large-Scale CNN Ensemble for Medication Safety Analysis

, 2017
Revealing Adverse Drug Reactions (ADR) is an essential part of post-marketing drug surveillance, and data from health-related forums and medical communities can be of a great significance for estimating such effects.
A Sarker, A Sarker, H Gurulingappa, WYS Chou   +3 more
core   +1 more source

Electronic health records to facilitate clinical research [PDF]

, 2016
Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome
Blomster, Juuso I., Cowie, Martin R., Curtis, Lesley H., Duclaux, Sylvie, Ford, Ian, Fritz, Fleur, Goldman, Samantha, Janmohamed, Salim, Kreuzer, Jörg, Leenay, Mark, Michel, Alexander, Ong, Seleen, Pell, Jill P., Southworth, Mary Ross, Stough, Wendy Gattis, Thoenes, Martin, Zalewski, Andrew, Zannad, Faiez   +17 more
core   +2 more sources

Real‐world comparative effectiveness and safety of Pertuzumab in patients with HER2+ metastatic breast cancer: A pan‐Canadian population‐based cohort study

International Journal of Cancer, EarlyView.
What's New? In Canada, complexities surrounding provincial cancer care and data access challenge the collection of robust multijurisdictional real‐world evidence (RWE) on cancer therapies. RWE, however, can provide critical insight into the safety and effectiveness of novel therapies. Here, for the Canadian Real‐world Evidence for Value of Cancer Drugs
Caroline E. Muñoz, Wei Fang Dai, Winson Y. Cheung, Claire de Oliveira, Reka E. Pataky, Philip Q. Ding, David A. Tran, Zeb Aurangzeb, Chenthila Nagamuthu, Ning Liu, Lynn Lethbridge, Carol McClure, Kim Vriends, Hui Xiong, Chris Folkins, Chandy Somayaji, Stuart Peacock, Riaz Alvi, Donna Turner, Carrie O'Conaill, Ted McDonald, Robin Urquhart, Cynthia Kendell, Jeff Dowden, Erin Strumpf, Avram Denburg, Jaclyn M. Beca, Rebecca E. Mercer, Mina Tadrous, Pam Takhar, Kelvin K. W. Chan, on behalf of the CanREValue Collaboration   +31 more
wiley   +1 more source