Drug Safety

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Drug-Induced Changes in the T-Wave Morphology
Drug Safety - - 2009
Marek Malík
Monitoring the Safety of Pioglitazone
Drug Safety - Tập 31 - Trang 839-850 - 2013
Rachna Kasliwal, V. Lynda, A. Saad
Background: Pioglitazone is an antidiabetic drug that targets insulin resistance in patients with type 2 diabetes mellitus by stimulating the peroxisome proliferatoractivated receptor (PPAR)-#$. Pioglitazone belongs to a class of drugs called thiazolidinediones (TZDs) and was launched in the UK in November 2000. Objective: To monitor, using prescription-event monitoring, the post-marketing safety ... hiện toàn bộ
HMG-CoA Reductase Inhibitors and Myotoxicity
Drug Safety - Tập 22 - Trang 441-457 - 2012
Memduh Ucar, Tom Mjörndal, Rune Dahlqvist
The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors specifically inhibit HMG-CoA reductase in the liver, thereby inhibiting the biosynthesis of cholesterol. These drugs significantly reduce plasma cholesterol level and long term treatment reduces morbidity and mortality associated with coronary heart disease. The tolerability of these drugs during long term administration is a... hiện toàn bộ
Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India
Drug Safety - Tập 46 - Trang 553-563 - 2023
Upinder Kaur, Zeba Fatima, Kalika Maheshwari, Vikas Sahni, Amol Dehade, Anju KL, Ashish Kumar Yadav, Sangeeta Kansal, Vaibhav Jaisawal, Sankha Shubhra Chakrabarti
Various vaccines for protection against COVID-19 were provided emergency approval in late 2020 to early 2021. There is a scarcity of long-term safety data for many of these. The main aim of this study is to provide the one-year safety results of the ChAdOx1-nCoV-19/AZD1222 vaccine and determine the risk factors of adverse events of special interest (AESIs) and persistent AESIs. This was a prospect... hiện toàn bộ
Validation of Statistical Signal Detection Procedures in EudraVigilance Post-Authorization Data
Drug Safety - Tập 33 - Trang 475-487 - 2012
Yolanda Alvarez, Ana Hidalgo, Francois Maignen, Jim Slattery
Background: Screening large databases of spontaneous case reports of possible adverse drug reactions (ADRs) is an established method of identifying hitherto unknown adverse effects of medicinal products; however, there is a lack of consensus concerning the value of formal statistical screening procedures in guiding such a process. This study was performed to clarify the nature of any added benefit... hiện toàn bộ
Benefits and Risks of Minocycline in Rheumatoid Arthritis
Drug Safety - Tập 22 - Trang 405-414 - 2012
Pnina Langevitz, Avi Livneh, Ilan Bank, Mordechai Pras
Rheumatoid arthritis is a chronic inflammatory disease affecting about 1% of the adult population. The pathophysiology of rheumatoid arthritis remains incompletely understood. An infectious aetiology of the disease has long been postulated, but not proved. Despite insufficient evidence for the infectious nature of this disorder, several antibacterials, such as sulfa compounds, tetracyclines and ri... hiện toàn bộ
Drug Interactions with Grapefruit Juice
Drug Safety - Tập 18 - Trang 251-272 - 2012
Uwe Fuhr
Concomitant intake with grapefruit juice increases the concentrations of many drugs in humans. The effect seems to be mediated mainly by suppression of the cytochrome P450 enzyme CYP3A4 in the small intestine wall. This results in a diminished first pass metabolism with higher bioavailability and increased maximal plasma concentrations of substrates of this enzyme. The effect was most pronounced i... hiện toàn bộ
Development Safety Update Reports and Proposals for Effective and Efficient Risk Communication
Drug Safety - Tập 33 - Trang 341-352 - 2012
Hisashi Urushihara, Koji Kawakami
The periodic safety reporting to regulatory authorities is globally harmonized for postmarketing medicinal products by the International Conference on Harmonisation (ICH) guidelines, and is being extended for investigational drugs. To facilitate effective safety risk communication regarding investigational drugs, and to reduce duplicate periodic reporting to the US and EU by sponsors during develo... hiện toàn bộ
Modified Prescription-Event Monitoring Studies
Drug Safety - Tập 34 - Trang e1-e9 - 2012
Deborah Layton, Lorna Hazell, Saad A.W. Shakir
Prescription-Event Monitoring (PEM) is a well established postmarketing surveillance technique designed to monitor the overall safety of newly marketed medicines as used in real-life clinical practice, usually in cohorts of at least 10000 patients. At the Drug Safety Research Unit in the UK we are now moving towards a more targeted safety surveillance known as Modified PEM (M-PEM). These studies c... hiện toàn bộ
An Intervention to Improve Spontaneous Adverse Drug Reaction Reporting by Hospital Physicians
Drug Safety - Tập 32 Số 1 - Trang 77-83 - 2009
Consuelo Pedrós, Antonio Vallano, Glòria Cereza, Gemma Mendoza-Aran, Antònia Agustí, Cristina Aguilera, Imma Danés, Xavier Vidal, Josep Maria Arnau
Tổng số: 2,730   
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