Results 1 to 10 of about 22,850 (157)

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

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   +2 more sources

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   +3 more sources

Digital Therapeutics in Perspective: From Regulatory Challenges to Post-Marketing Surveillance

Frontiers in Drug Safety and Regulation, 2022
Digital therapeutics (DTx) are innovative therapeutic interventions, in which the therapeutic activity is carried out by algorithms and software. They represent a new opportunity especially for the treatment of chronic pathologies associated with ...
Salvatore Crisafulli, Eugenio Santoro, Giuseppe Recchia, Giuseppe Recchia, Gianluca Trifirò   +4 more
doaj   +3 more sources

Real-World Safety and Effectiveness of Evolocumab in Korean Patients with Atherosclerotic Cardiovascular Disease or Familial Hypercholesterolemia: A Post-Marketing Surveillance Study [PDF]

Cardiology and Therapy
Introduction The efficacy and safety of evolocumab have been established in clinical trials. This post-marketing surveillance (PMS) study investigated the real-world safety and effectiveness of evolocumab in patients with atherosclerotic cardiovascular ...
Donggyu Moon, Seung-Ho Hur, Sang-Rok Lee, Myung Ho Jeong, Kyung Hoon Cho, Osung Kwon, JinSeon Jeong, Ki Dong Yoo, Evolocumab Post-Marketing Surveillance Research Group   +8 more
doaj   +2 more sources

Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus treated in real‐world clinical practice: Results of a 36‐month post‐marketing surveillance study (J‐STEP/LT)

Journal of Diabetes Investigation, 2021
Aims/Introduction Tofogliflozin is a sodium–glucose cotransporter 2 (SGLT2) inhibitor that lowers plasma glucose levels by enhancing urinary glucose excretion.
Kazunori Utsunomiya, Ryusuke Koshida, Seigo Kakiuchi, Masayuki Senda, Shoko Fujii, Yuji Kurihara, Ryoji Gunji, Kohei Kaku   +7 more
doaj   +1 more source

Correction to: Safety and efficacy of ripasudil in Japanese patients with glaucoma or ocular hypertension: 12-month interim analysis of ROCK-J, a post-marketing surveillance study

BMC Ophthalmology, 2020
An amendment to this paper has been published and can be accessed via the original article.
Hidenobu Tanihara, Takahiko Kakuda, Tetsuro Sano, Takashi Kanno, Ryoji Gunji   +4 more
doaj   +1 more source

Safety and efficacy of ripasudil in Japanese patients with glaucoma or ocular hypertension: 12-month interim analysis of ROCK-J, a post-marketing surveillance study

BMC Ophthalmology, 2020
Background Ripasudil is approved in Japan for glaucoma or ocular hypertension (OH) when other treatments are ineffective or cannot be administered. Its long-term safety and efficacy are being examined in a post-marketing surveillance study; 12-month data
Hidenobu Tanihara, Takahiko Kakuda, Tetsuro Sano, Takashi Kanno, Ryoji Gunji   +4 more
doaj   +1 more source

Postmarketing observational study on the safety of 2021/2022 and 2022/2023 influenza vaccination campaigns in Italy: TheShinISS-Vax|Flu study protocol

BMJ Open, 2023
Introduction The purpose of TheShinISS-Vax|Flu study is to examine the association between influenza vaccines and adverse events requiring hospital admission or emergency care during the influenza vaccination campaigns 2021/2022 and 2022/2023 in Italy ...
Roberto Da Cas, Marco Massari, Stefania Spila Alegiani, Francesca Menniti-Ippolito, Cristina Morciano, Patrizia Felicetti, Pasquale Marchione, Fiorella Petronzelli, Anna Rosa Marra   +8 more
doaj   +1 more source

Disentangling a Thorny Issue: Myocarditis and Pericarditis Post COVID-19 and Following mRNA COVID-19 Vaccines

Pharmaceuticals, 2022
Considering the clinical significance for myocarditis and pericarditis after immunization with mRNA COVID-19 vaccines, the present pharmacovigilance study aimed to describe these events reported with mRNA COVID-19 vaccines in the Vaccine Adverse Events ...
Concetta Rafaniello, Mario Gaio, Alessia Zinzi, Maria Giuseppa Sullo, Valerio Liguori, Marialuisa Ferraro, Fiorella Petronzelli, Patrizia Felicetti, Pasquale Marchione, Anna Rosa Marra, Francesco Rossi, Antonella De Angelis, Annalisa Capuano   +12 more
doaj   +1 more source

Single‐pill combination of cilnidipine, an l‐/n‐type calcium channel blocker, and valsartan reduces the day‐by‐day variability of morning home systolic blood pressure in patients with treated hypertension: A sub‐analysis of the HOPE‐combi survey

The Journal of Clinical Hypertension, 2021
We examined the effects of a fixed‐dose single‐pill combination of cilnidipine (10 mg), an L‐/N‐type calcium channel blocker, and valsartan (80 mg) (SPC of Cil/Val) on the day‐by‐day variability of morning home systolic blood pressure (MHSBP) in 616 ...
Kazuomi Kario, Saori Matsuda, Shinobu Nagahama, Yoshiki Kurose, Hitoshi Sugii, Tsukasa Teshima, Noriyuki Suzuki   +6 more
doaj   +1 more source