PCV2 POSTMARKETING SAFETY EVALUATION OF ALISKIREN HEMIFUMARATE, A NEW MOLECULAR ENTITY
نویسندگان
چکیده
منابع مشابه
Pharmacovigilance analysis of adverse event reports for aliskiren hemifumarate, a first-in-class direct renin inhibitor
BACKGROUND The purpose of this study was to examine the postmarketing safety profile of aliskiren hemifumarate, a first-in-class direct renin inhibitor. METHODS The US Adverse Event Reporting System (AERS) was utilized to conduct a retrospective pharmacovigilance analysis by applying the Multi-item Gamma Poisson Shrinker data mining algorithm to calculate empiric Bayes geometric mean (EBGM) v...
متن کاملPostmarketing Evaluation of Drugs
Round table no. 2 was devoted to the postmarketing evaluation of drugs. The debates involved both the questions posed by postmarketing evaluation and the methods for responding to them. The major categories of questions likely to be posed are as follows: efficacy in actual situations; safety in actual situations; prognostic factors and patients responding; place in the therapeutic strategy; imp...
متن کاملPostmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies
Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we addr...
متن کاملMonitoring product safety in the postmarketing environment.
The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the develo...
متن کاملAliskiren: A New Harbinger of Hypotension?
We present a case of significant, persistent, and relatively refractory hypotension during general anesthesia in a reasonably healthy 50-year-old man thought to be caused by a direct rennin inhibitor. This case is of particular significance because the medication thought responsible for the hemodynamic abnormalities is a relatively novel antihypertensive agent and remains largely unknown to cli...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Value in Health
سال: 2010
ISSN: 1098-3015
DOI: 10.1016/s1098-3015(10)72724-8