Results 11 to 20 of about 31,766 (260)

Safety and Effectiveness of Molnupiravir (LAGEVRIO®) Capsules in Japanese Patients with COVID-19: Interim Report of Post-marketing Surveillance in Japan

Infectious Diseases and Therapy, 2023
Introduction Molnupiravir is an oral antiviral drug that received special approval for emergency use in Japan on December 24 2021 for infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Masahiro Kimata, Asuka Watanabe, Yukiko Yanagida, Daisuke Kinoshita, Shinichiroh Maekawa   +4 more
doaj   +1 more source

Identification of International Society on Thrombosis and Haemostasis major and clinically relevant non-major bleed events from electronic health records: a novel algorithm to enhance data utilisation from real-world sources

International Journal of Population Data Science, 2023
Introduction In randomised controlled trials (RCTs), bleeding outcomes are often assessed using definitions provided by the International Society on Thrombosis and Haemostasis (ISTH).
Alexander Hartenstein, Khaled Abdelgawwad, Frank Kleinjung, Stephen Privitera, Thomas Viethen, Tatsiana Vaitsiakhovich   +5 more
doaj   +1 more source

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

Frontiers in Drug Safety and Regulation, 2023
Background: Pregnant women have a higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection. COVID-19 vaccination can prevent (severe) infection.
M. de Feijter, L. C. M. Vissers, L. Davidson, A. C. Kant, A. C. Kant, P. J. Woestenberg   +5 more
doaj   +1 more source

Pharmacovigilance

International Journal of Pharmaceutical Sciences Review and Research, 2021
Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefit ratio of drugs, improving patient’s safety and the quality of life.
Adiba Nousheen, Asra Asra, Hasnat Fatima, Nashra Nizami, Sarah Noureen, Syed Amair Ali, B. Tazneem Tazneem, Syeda Zuleqaunnisa Begum   +7 more
  +5 more sources

Clinical characteristics and risk factors for cefaclor-induced immediate hypersensitivity: a retrospective observation at two university hospitals in Korea

Allergy, Asthma & Clinical Immunology, 2021
Background Cefaclor, a second-generation oral cephalosporin, is widely prescribed to treat infectious diseases. Immediate hypersensitivity (HS) reactions to cefaclor have continuously been reported and are expected to increase with its greater use.
Hyo-In Rhyou, Go-Eun Doo, Jiwon Yoon, Chae-Yeon Ha, Hee-Joo Nam, Sung-Dae Woo, Youngsoo Lee, Young-Hee Nam, Young-Min Ye   +8 more
doaj   +1 more source

Evaluation of Pharmacovigilance System in Iran [PDF]

International Journal of Health Policy and Management, 2022
BackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems ...
Malahat Khalili, Hamid Sharifi, Bita Mesgarpour, Mehrnaz Kheirandish, Sten Olsson, Naghmeh Javidnikou, Ali Akbar Haghdoost   +6 more
doaj   +1 more source

Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees

BMC Medical Ethics, 2021
Background This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review ...
G. Benfatto, Regulatory Group, Ethics Committee Catania 1 (Group), F. Drago   +3 more
doaj   +1 more source

Correction to: Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees

BMC Medical Ethics, 2021
An amendment to this paper has been published and can be accessed via the original article.
G. Benfatto, Regulatory Group, Ethics Committee Catania 1 (Group), F. Drago   +3 more
doaj   +1 more source

Pharmacovigilance

International journal of health sciences, 2022
The World Health Organization (WHO) defines Pharmacovigilance as the science & activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The National Pharmacovigilance Programme (NPVP) was launched in 2004 with World Bank funding till 2009, which was renamed as Pharmacovigilance
Shruti Brahmbhatt, Mahavirsingh Rajput
openaire   +1 more source

An evaluation of postmarketing reports of hyperglycaemia associated with dolutegravir for treatment of HIV in Eswatini

AIDS Research and Therapy, 2022
Background Dolutegravir (DTG) is an Integrase Strand Transfer Inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV infection.
Alemayehu L. Duga, Sibongile Magongo, Siphesihle Nhlabatsi, Denis O. Ladwar, Linda Härmark, Leàn Rolfes   +5 more
doaj   +1 more source