- Embedding 'Speaking Up' into Systems for Safe Healthcare Product Development and Marketing Surveillance
[作者：Edwards, B; Hugman, B; Tobin, M; Whalen, M,期刊：Drug safety, 页码：265-271 , 文章类型： Article，,卷期：2012年35-4]
- Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most ...
- Safety of Flecainide
[作者：Tamargo, J; Capucci, A; Mabo, P,期刊：Drug safety, 页码：273-289 , 文章类型： Review，,卷期：2012年35-4]
- Flecainide is a class Ic antiarrhythmic agent that has an important role as part of rhythm control strategies in patients with atrial fibrillation (AF). Early clinical data on the use of flecainide showed an increase in ...
- Assessing Opioid Shopping Behaviour A Large Cohort Study from a Medication Dispensing Database in the US
[作者：Cepeda, MS; Fife, D; Chow, W; Mastrogiovanni, G; Henderson, SC,期刊：Drug safety, 页码：325-334 , 文章类型： Article，,卷期：2012年35-4]
- Background: Risks of abuse, misuse and diversion of opioids are of concern. Obtaining opioid prescriptions from multiple prescribers, known as opioid shopping, is a way in which opioids may be abused and diverted. Previo...
- Vaccine-Based Subgroup Analysis in VigiBase Effect on Sensitivity in Paediatric Signal Detection
[作者：de Bie, S; Verhamme, KMC; Straus, SMJM; Stricker, BHC; Sturkenboom, MCJM,期刊：Drug safety, 页码：335-346 , 文章类型： Article，,卷期：2012年35-4]
- Background: Data mining of spontaneously reported adverse drug reactions (ADRs), using measures of disproportionality, is a valuable first evaluation step for drug safety signal detection. Of all ADRs reported for childr...
- Risk Minimization Activities of Centrally Authorized Products in the EU A Descriptive Study
[作者：Zomerdijk, IM; Sayed-Tabatabaei, FA; Trifiro, G; Blackburn, SCF; Sturkenboom, MCJM; Straus, SMJM,期刊：Drug safety, 页码：299-314 , 文章类型： Article，,卷期：2012年35-4]
- Background: Since the new legislation on risk management, which came into force in November 2005, an EU Risk Management Plan (EU-RMP) is a required part of the authorization dossier of innovative drugs licensed in the EU...
- Cardiovascular, Ocular and Bone Adverse Reactions Associated with Thiazolidinediones A Disproportionality Analysis of the US FDA Adverse Event Reporting System Database
[作者：Motola, D; Piccinni, C; Biagi, C; Raschi, E; Marra, A; Marchesini, G; Poluzzi, E,期刊：Drug safety, 页码：315-323 , 文章类型： Article，,卷期：2012年35-4]
- Background: The risk of myocardial infarction, macular oedema and bone fractures associated with thiazolidinediones (TZDs) has been extensively investigated. Objective: The aim of the study was to verify if the analysis ...
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