Results 21 to 30 of about 802 (167)

Post-marketing stability surveillance: Amoxicillin

South African Family Practice, 2006
Background: To ensure the successful treatment of infectious disease using antimicrobial therapy, a sufficient concentration of the stable, active drug is required at the site of infection.
K.K. Naidoo, P. Nompuku, S.N. Mkalali, K. Shabangu, L. Nkabinde, V. Singh   +5 more
doaj   +1 more source

A Machine Learning-Aided Framework to Predict Outcomes of Anti-PD-1 Therapy for Patients With Gynecological Cancer on Incomplete Post-Marketing Surveillance Dataset

IEEE Access, 2021
Post-marketing surveillance of antineoplastic agents is performed to evaluate the efficacy and safety in patients aiming at expanding drug indications and discovering potential adverse events.
Xiaomei Liu, Zhifeng Xiao, Yang Song, Ruizhe Zhang, Xiuqin Li, Zhenhua Du   +5 more
doaj   +1 more source

Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance

Frontiers in Psychiatry, 2022
Schizophrenia is an unexplained, complex and serious mental illness. Blonanserin (BNS) is a new antipsychotic drug widely used in the treatment of schizophrenia. However, large-scale clinical studies have not been conducted in China.
Haishan Wu, Xijin Wang, Xuejun Liu, Hong Sang, Qijing Bo, Xiaodong Yang, Zhiyuan Xun, Keqing Li, Ruiling Zhang, Meijuan Sun, Duanfang Cai, Huaili Deng, Guijun Zhao, Juhong Li, Xianglai Liu, Guilai Zhan, Jindong Chen   +16 more
doaj   +1 more source

Low Incidence of Relapses After Vaccination in Anti‐Aquaporin‐4 Antibody‐Positive NMOSD

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Patients with neuromyelitis optica spectrum disorder (NMOSD) may experience increased signs and symptoms of their underlying disease when vaccinated against meningococcal disease before receiving complement component 5 inhibitor therapies. This retrospective analysis indicated an overall low relapse incidence (mean [range], 3.3% [0.7%–10.6 ...
Sean J. Pittock, Jin Nakahara, Becky Parks, Kerstin Allen, Sami Fam   +4 more
wiley   +1 more source

Safety Profile of Oxaliplatin in 3,687 Patients With Cancer in China: A Post-Marketing Surveillance Study

Frontiers in Oncology, 2021
BackgroundOxaliplatin (OXA), a third-generation platinum derivative, has become one of the main chemotherapeutic drugs for colorectal cancer and other cancers, but reports of adverse reactions are also increasing with the extensive application of OXA. In
Zaoqin Yu, Rui Huang, Li Zhao, Ximin Wang, Xiaofang Shangguan, Wei Li, Min Li, Xianguo Yin, Chengliang Zhang, Dong Liu   +9 more
doaj   +1 more source

Onasemnogene Abeparvovec in Patients With SMA: Interim Results of the RESTORE Registry in Japan

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective There are limited real‐world data regarding the safety and effectiveness of onasemnogene abeparvovec (OA; Zolgensma) infusion, a one‐time gene replacement therapy, for Japanese patients with spinal muscular atrophy (SMA). We aimed to improve understanding of the real‐world outcomes for OA in Japan.
Kayoko Saito, Kamal Benguerba, Ken Tsuchida, Kazushige Yazawa, Isao Tsumiyama, Hiromitsu Kayama, Sandra P. Reyna, Farid Khan, Richard S. Finkel   +8 more
wiley   +1 more source

Six‐Year Trends in Real‐World Data Use for Post‐Marketing Surveillance of New Medical Products in Japan

Clinical and Translational Science
The Ministerial Ordinance on Good Post‐Marketing Study Practice for Drugs was amended by the Ministry of Health, Labour and Welfare (MHLW) in 2018 to clearly define post‐marketing database studies (DBS) as a measure of pharmacovigilance activities for ...
Suguru Okami, Kako Shimotsumagari, Yasunari Sadatsuki   +2 more
doaj   +1 more source

Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future

Therapeutic Advances in Drug Safety, 2020
Background: To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an ...
Muaed Alomar, Ali M Tawfiq, Nageeb Hassan, Subish Palaian   +3 more
doaj   +1 more source

Biologics for Inflammatory Bowel Disease in Clinical Practice: A Calabria (Southern Italy) Prospective Pharmacovigilance Study

Pharmaceutics, 2022
Background: The use of immune-modifying biological agents has markedly changed the clinical course and the management of Inflammatory bowel diseases (IBDs).
Martina Tallarico, Caterina Palleria, Livia Ruffolo, Rocco Spagnuolo, Maria Diana Naturale, Adele Emanuela De Francesco, Caterina De Sarro, Rossella Romeo, Rita Citraro, Patrizia Doldo, Ludovico Abenavoli, Luca Gallelli, Francesco Luzza, Antonio Leo, Giovambattista De Sarro   +14 more
doaj   +1 more source

Translational Considerations for Injectable Biomaterials and Bioscaffolds to Repair and Regenerate Brain Tissue

Advanced Healthcare Materials, EarlyView.
The repair and regeneration of brain tissue faces both biological and technical challenges. Injectable bioscaffolds offer new opportunities to stimulate tissue regrowth in the brain by recruiting neural stem cells. Here, the translational issues are reviewed that need to be address to advance this promising new therapeutic approach from the bench to ...
Michel Modo, Alena Kisel
wiley   +1 more source