Results 21 to 30 of about 5,946 (190)

Safety and effectiveness of edoxaban in Japanese patients with nonvalvular atrial fibrillation: Final report of a two‐year postmarketing surveillance study (ETNA‐AF‐Japan)

Journal of Arrhythmia, 2021
Background Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).
Takeshi Yamashita, Yukihiro Koretsune, Tomoko Nagao, Kazuhito Shiosakai   +3 more
doaj   +1 more source

Postmarketing Surveillance for "Modified-Risk" Tobacco Products [PDF]

Nicotine & Tobacco Research, 2011
The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have "modified-risk" for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of ...
openaire   +2 more sources

Product-to-product differences in plasma concentration-time curves from recommended doses of prolonged-action preparations of theophylline

South African Family Practice, 1985
No abstract available.
R.S. Summers
doaj   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

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

Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]

, 2010
Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y., Fogg, Carole, Layton, D., Shakir, S.   +3 more
core   +1 more source

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada

Therapeutic Advances in Drug Safety, 2019
Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj, Swapnil Fernandes, Narayana R. Charyulu, Akhilesh Dubey, Ravi G. S., Srinivas Hebbar   +5 more
doaj   +1 more source

Trends and characteristics of accidental and intentional codeine overdose deaths in Australia [PDF]

, 2015
Examines trends in codeine-related mortality rates in Australia, and the clinical and toxicological characteristics of codeine-related deaths. Abstract Objectives: To examine trends in codeine-related mortality rates in Australia, and the clinical and ...
Amanda Roxburgh, Eva Saar, Jennifer Pilgrim, Louisa Degenhardt, Lucinda Burns, Suzanne Nielsen, Wayne D Hall   +6 more
core   +1 more source

Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China

Journal of Epidemiology, 2014
China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China.
Cui, Fuqiang, Liang, Xiaofeng, Wang, Fuzhen, Zheng, Hui, Hutin, Yvan J, Yang, Weizhong   +5 more
openaire   +3 more sources

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus: A subgroup analysis of 3‐month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use study

Journal of Diabetes Investigation, 2019
Aims/Introduction Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use is an ongoing postmarketing study of ipragliflozin for long‐term use in Japanese patients with type 2 diabetes mellitus.
Kazuyuki Tobe, Hiroshi Maegawa, Hiromi Tabuchi, Ichiro Nakamura, Satoshi Uno   +4 more
doaj   +1 more source