Results 71 to 80 of about 51,036 (300)

Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance

BMC Cancer, 2023
Background This study was conducted to identify factors associated with the safety and effectiveness of pembrolizumab in Japanese patients with unresectable urothelial carcinoma and to confirm the real-world safety and effectiveness of pembrolizumab in ...
Hiroyuki Nishiyama, Yu Tanaka, Masahiro Hamada, Masahiko Ozaki, Toshihiko Minegishi, Yuichiro Ito, Shinichiroh Maekawa, Nobuyuki Yamamoto   +7 more
doaj   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source

Differences Between RSV A and RSV B Subgroups and Implications for Pharmaceutical Preventive Measures

Infectious Diseases and Therapy
Introduction Understanding the differences between respiratory syncytial virus (RSV) subgroups A and B provides insights for the development of prevention strategies and public health interventions.
Charles Nuttens, Juliette Moyersoen, Daniel Curcio, Zuleika Aponte-Torres, Marc Baay, Hilde Vroling, Bradford D. Gessner, Elizabeth Begier   +7 more
doaj   +1 more source

Awareness of the Black Triangle Scheme among healthcare professionals and consumers in Australia: A mixed‐methods study exploring reporting intentions and suggested improvements

British Journal of Clinical Pharmacology, EarlyView.
Aims The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements.
Eyob Alemayehu Gebreyohannes, Sieta T. de Vries, Mohammed Gebre Dedefo, Oliver Frank, Myra Thiessen, Lisa Kalisch Ellett, Christopher Thornton, Renly Lim   +7 more
wiley   +1 more source

A post-marketing surveillance study on the safety and effectiveness of recombinant antithrombin gamma in patients with congenital antithrombin deficiency in Japan

Thrombosis Journal
Background Congenital antithrombin deficiency (CAD) is a serious inherited thrombophilia, classified as a rare disease. According to a study measuring antithrombin (AT) activity in the general Japanese population, approximately one in 650 people (0.15 ...
Hidesaku Asakura, Manabu Iwabuchi, Masaki Fujita, Satoru Ito, Yuka Kanda, Hiroshi Kuwazawa   +5 more
doaj   +1 more source

Effect of Pharmacovigilance on Herbal Medicines

, 2019
Ayurvedic Medicines has major role in treatment of disease, this is originated from India and now it is accepted in other countries. Pharmacovigilance is related to detection, assessment, understanding and prevention of adverse drug reaction of drug and ...
Lovely Chaurasia, Ms. Charu Saxena, Geeta Rawat, Saxena, Ms. Charu, Rawat, Geeta, Chaurasia, Lovely   +5 more
core   +1 more source

Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators

BMC Pharmacology and Toxicology, 2018
Background WHO pharmacovigilance indicators have been recommended as a useful tool towards improving pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of pharmacovigilance at peripheral centres ...
Abimbola O. Opadeyi, Annie Fourrier-Réglat, Ambrose O. Isah   +2 more
doaj   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Safety and Effectiveness of Molnupiravir in Japanese Patients with COVID-19: Final Report of Post-marketing Surveillance in Japan

Infectious Diseases and Therapy
Introduction Molnupiravir is an orally available prodrug of N-hydroxycytidine that received special approval for emergency treatment of coronavirus disease 2019 (COVID-19) in Japan in December 2021 and full approval in April 2023.
Shohei Shinozaki, Asuka Watanabe, Masahiro Kimata, Makoto Miyazaki, Shinichiroh Maekawa   +4 more
doaj   +1 more source

A REVIEW ON PHARMACOVIGILANCE STUDY OF VACCINES

, 2020
Pharmacovigilance systems are needed to safeguard the public health. The pharmacovigilance study of vaccines means science and activities related to detection, assessment, understanding, prevention and communication of adverse events of vaccines.
Kiran Kulkarni, Snehal Shetti and Shrikant Magdum
core   +1 more source