Results 81 to 90 of about 12,493 (244)

Effectiveness of drug postmarketing all-case surveillance as a safety measure in Japan

Therapeutic Advances in Drug Safety, 2021
Introduction: The drug pharmacovigilance system in Japan is similar to those in the European Union (EU) and the United States. As a unique Japanese pharmacovigilance program, postmarketing all-case surveillance (PMACS) is required. PMACS plays a key role
Hideyuki Kondo, Ken Masamune
doaj   +1 more source

Regulating risks in pharmaceutical law : the need of an optimal interplay between products safety and products liability [PDF]

, 2011
Published online: 7 June 2011The aim of this paper is to call for the need of a theoretical model of pharmaceutical products safety in which the two systems of regulation and liability operate complementarily. The question is why two legal tools that are
RIZZI, Marco
core  

Completeness of spontaneously reported adverse drug reactions in 4 databases

British Journal of Clinical Pharmacology, Volume 91, Issue 12, Page 3389-3400, December 2025.
Aims To assess the completeness of information provided in adverse drug reaction (ADR) reports in 4 spontaneous report databases. Methods The study was conducted using freely accessible ADR reports from the Canada Vigilance Adverse Reaction Online Database, the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, the UK ...
Mohammed Gebre Dedefo, Gizat M. Kassie, Eyob Alemayehu Gebreyohannes, Renly Lim, Elizabeth Roughead, Lisa Kalisch Ellett   +5 more
wiley   +1 more source

Incomplete Resolution of Deep Vein Thromboses during Rivaroxaban Therapy. [PDF]

, 2017
We present the case of a patient with a deep vein thrombosis (DVT) who failed rivaroxaban therapy. Our patient initially presented with left lower extremity edema, erythema, and pain.
Adashek, Jacob, Ben-Zur, Uri M, Nagar, Menachem, Pietras, Richard J, Toomari, Nojan, Yaghoubian, Jonathan M, Yaghoubian-Yazi, Bahareh   +6 more
core   +5 more sources

Evolving Real‐World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan—An Analysis of the 6‐Year Trend

Clinical Pharmacology &Therapeutics, Volume 118, Issue 6, Page 1405-1421, December 2025.
Several regulatory initiatives have been made to clarify the acceptability and requirements of real‐world data and real‐world evidence (RWD/E) for the benefit/risk assessment of new medical products in Japan. The objectives of this review were to characterize the use of RWD/E in regulatory applications of new medical products and to describe the ...
Suguru Okami, Kako Shimotsumagari, Yasunari Sadatsuki   +2 more
wiley   +1 more source

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

Therapeutics and Clinical Risk Management, 2016
Abdel Naser Zaid,1 Masshour Ghanem,2 Dua’a Shweiki,1 Hala Shtewi,1 Raja’ Shaheen,1 Sondos Al Helaly,1 Zeina Khayyat,1 Rowa’a Al Ramahi,1 Sa’ed H Zyoud1 1Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah ...
Zaid AN, Ghanem M, Shweiki D, Shtewi H, Shaheen R, Al Helaly S, Khayyat Z, Al Ramahi R, Zyoud SH   +8 more
doaj  

SAFETY EVALUATION OF STATIN IN YOGYAKARTA, INDONESIA [PDF]

, 2009
Background : The 3-hydroxy-3-methylglutaryl-coenzyme (HMG-Co-A) reductase inhibitors, also known as statins, are the most effective class of drugs for lowering serum Low-Density Lipoprotein cholesterol (LDL-c)concentrations.
Anni, Anni, Labado, R.O., Perwitasari, Dyah Aryani, Udu, W.S.A.   +3 more
core  

Musculoskeletal Diseases: Mechanisms and Therapeutic Advances

MedComm, Volume 6, Issue 12, December 2025.
Musculoskeletal diseases comprise a broad spectrum of inflammatory, degenerative, and neoplastic disorders. Increasing evidence highlights the central role of immune regulation in their pathogenesis, with complex interactions among immune, bone, muscle, and stromal cells.
Xiao Ma, Eloy Yinwang, Xupeng Chai, Fangqian Wang, Zehao Chen, Shengdong Wang, Hao Zhou, Yucheng Xue, Jiangchu Lei, Fanglu Chen, Hengyuan Li, Shixin Chen, Shenzhi Zhao, Kelei Wang, Liang Chen, Junjie Gao, Zhaoming Ye, Nong Lin   +17 more
wiley   +1 more source

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

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

, 2020
Goeun Park, Heesun Jung, Seok‐Jae Heo, Inkyung Jung   +3 more
openalex   +1 more source