Results 31 to 40 of about 25,471 (263)

Materiovigilance: An Indian perspective

Perspectives in Clinical Research, 2018
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences.
Bikash Ranjan Meher
doaj   +1 more source

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

Clinical and Translational Science, 2022
Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases.
Julie Hsieh, Martina Sahre, Xinning Yang, Rajanikanth Madabushi, Anuradha Ramamoorthy   +4 more
doaj   +1 more source

Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance

Life, 2020
There are several different proposed data mining methods for the postmarketing surveillance of drug safety. Adverse events are often classified into a hierarchical structure. Our objective was to compare the performance of several of these different data
Goeun Park, Heesun Jung, S. Heo, I. Jung
semanticscholar   +1 more source

Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland

Swiss Medical Weekly, 2021
AIM OF THE STUDY In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and ...
Beat Müllhaupt, David Semela, Lisa Ruckstuhl, Lorenzo Magenta, Olivier Clerc, Ralph Torgler, Francesco Negro, Nasser Semmo   +7 more
doaj   +1 more source

The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. [PDF]

, 2016
PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were ...
Andrews, Elizabeth B, Deapen, Dennis M, Gilsenan, Alicia W, Harris, David H, Hornicek, Francis J, Midkiff, Kirk D, Schymura, Maria J   +6 more
core   +1 more source

Glycoprotein IIb/IIIa Inhibitors Use and Outcome after Percutaneous Coronary Intervention for Non-ST Elevation Myocardial Infarction [PDF]

, 2014
Aims. We investigate the effect of glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors on long-term outcomes following percutaneous coronary intervention (PCI) after non-ST elevation myocardial infarction (NSTEMI). Meta-analyses indicate that these agents are
Antoniou, S, Gallagher, S, Howard, JP, Jones, DA, Knight, C, Mathur, A, Rathod, K, Weerackody, R, Wragg, A, Wright, P   +9 more
core   +9 more sources

Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital

Journal of Research in Pharmacy Practice, 2019
Objective: Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction.
Jair Antonio Ruiz-Garzon, Camilo Andrés Rojas-Velandia, Carlos-Alberto Calderon-Ospina   +2 more
doaj   +1 more source

Edoxaban: an update on the new oral direct factor Xa inhibitor. [PDF]

, 2014
Edoxaban is a once-daily oral anticoagulant that rapidly and selectively inhibits factor Xa in a concentration-dependent manner. This review describes the extensive clinical development program of edoxaban, including phase III studies in patients with ...
A. John Camm, AC Skanes, AG Turpie, AJ Camm, AK Kakkar, AT Cohen, B Laulicht, BF Gage, BI Eriksson, BI Eriksson, BI Eriksson, BI Eriksson, BS Stambler, C Kearon, CB Granger, CT Ruff, DE Salazar, G Agnelli, G Agnelli, G Lu, G Raskob, G Raskob, H Masumoto, H Zahir, Henri Bounameaux, J Mendell, J Mendell, J Mendell, J Mendell, J Mendell, J Mendell, J Stampfuss, JH Alexander, JI Weitz, JL Mega, K Ogata, KL Furie, LT Grip, M Crowther, M Hori, M Pirmohamed, MR Lassen, MR Lassen, MR Lassen, MR Lassen, MR Patel, MS Bathala, MU Zafar, N Chung, N Matsushima, R Caterina De, R Caterina De, RP Giugliano, S Kaatz, S Schulman, S Schulman, S Schulman, SE Kimmel, SJ Connolly, SJ Connolly, SJ Connolly, SZ Goldhaber, T Fuji, T Fuji, T Fukuda, T Hulle van der, T Mikkaichi, T Wilke, T Yamashita, TI Verhoef, W Mueck, Y Falck-Ytter, Y Kuroda   +72 more
core   +1 more source

Antidepressants and movement disorders: a postmarketing study in the world pharmacovigilance database

BMC Psychiatry, 2020
Background Antidepressants-induced movement disorders are rare and imperfectly known adverse drug reactions. The risk may differ between different antidepressants and antidepressants’ classes.
A. Revet, F. Montastruc, A. Roussin, J. Raynaud, M. Lapeyre-Mestre, Thi Thu Ha Nguyen   +5 more
semanticscholar   +1 more source

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

BMC Medicine, 2019
Background Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation.
Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva, Jennifer E. Miller, Joseph S. Ross   +4 more
doaj   +1 more source