Results 41 to 50 of about 27,419 (207)

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

Clinics, 2014
OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify ...
Fabiana Rossi Varallo, Helaine Carneiro Capucho, Cleópatra da Silva Planeta, Patrícia de Carvalho Mastroianni   +3 more
doaj   +1 more source

Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study [PDF]

Diabetes & Metabolism Journal
Background To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM). Methods This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park   +5 more
doaj   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Postmarketing drug surveillance: an epidemiologic approach.

Clinical Therapeutics, 1998
Postmarketing surveillance refers to any means of gathering information about a product after it has been approved for public use. Postmarketing surveillance studies address assorted aspects of beneficial and detrimental adverse drug effects, including ...
S. Hennessy
semanticscholar   +1 more source

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

Collagen‐membrane‐covered matrix‐associated chondrocyte implantation improves safety over periosteum‐covered MACI for large knee cartilage defects: A real‐world data analysis in the registry study

Knee Surgery, Sports Traumatology, Arthroscopy, EarlyView.
Abstract Purpose This registry study aimed to evaluate the safety and effectiveness of collagen membrane‐covered matrix‐associated autologous chondrocyte implantation (cMACI) versus periosteum‐covered MACI (pMACI) for large knee cartilage defects (Outerbridge III–IV, ≥4 cm²) in the femorotibial and/or patellofemoral joints with a minimum 2‐year follow ...
Yuji Uchio, Ryosuke Kuroda, Yasuo Niki, Katsura Sugawara, Yasuyuki Ishibash   +4 more
wiley   +1 more source

Real‐World Safety and Effectiveness of Glatiramer Acetate in Patients With Multiple Sclerosis: Final Results of Post‐Marketing Surveillance in Japan

Neurology and Clinical Neuroscience, EarlyView.
ABSTRACT Background Glatiramer acetate is an injectable disease‐modifying therapy indicated for multiple sclerosis (MS). Aim To evaluate the real‐world safety and effectiveness of glatiramer acetate for MS in Japan. Methods A prospective, multicenter, observational, all‐case post‐marketing survey was conducted in Japan between November 2015 and March ...
Masaaki Niino, Eriko Hayashi, Mai Itani, Jun‐ichi Kira   +3 more
wiley   +1 more source

Traceability of biologicals: present challenges in pharmacovigilance [PDF]

, 2015
Introduction: Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks.
Vermeer, NS, Giezen, TJ, Mantel-Teeuwisse, AK, Egberts, TCG (Toine), Spierings, I, Straus, Sabine, de Bruin, ML (Marie), Leufkens, HGM   +7 more
core   +2 more sources

Avaliação do sistema brasileiro de vigilância de eventos adversos pós-vacinação Evaluation of the Brazilian surveillance system for adverse events following vaccination

Revista Brasileira de Epidemiologia, 2011
OBJETIVOS: Descrever e avaliar o Sistema brasileiro de vigilância passiva de eventos adversos pós-vacinação (SPVEAPV). MÉTODOS: A descrição e avaliação do SPVEAPV fundamentaram-se nas notificações de eventos adversos pós-vacina Tetravalente ou DTwP/Hib -
Sandra Aparecida Moreira Gomes Monteiro, Olga Akiko Takano, Eliseu Alves Waldman   +2 more
doaj   +1 more source

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

Journal of Analytical Science and Technology, 2020
Venetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies.
Dhruvisha Pokar, Amit Kumar Sahu, Pinaki Sengupta   +2 more
doaj   +1 more source