Post-market drug surveillance projects developing slowly.
نویسنده
چکیده
منابع مشابه
Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
BACKGROUND In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirem...
متن کاملAutomating Pharmaceutical Safety Surveillance process
Pharmaceutical companies invest huge amount of effort and cost in launching a drug into the market, keeping the two aspects in mind i.e. safety and efficacy. Post launching the drugs into the market, the organisations then need to monitor the adverse events from these drugs, and need to take the action accordingly. In this white paper few approaches are discussed for automating the post market ...
متن کاملPharmacovigilance and post-black market surveillance.
Pharmacovigilance can be defined as a set of practices aiming at the detection, understanding and assessment of risks related to the use of drugs in a population, and the prevention of consequential adverse effects. In a narrower sense, the term refers exclusively to postmarket surveillance. This paper briefly outlines how pharmacovigilance has come to play a central role in the regulation of n...
متن کاملStatistics for Drug Development in Big Data Era: Challenges in Design, Analysis and Reproducibility
The statistical methods used for data-mining or signal detection of drug-adverse event combinations from large drug safety databases such as FDA’s Adverse Event Reporting System (FAERS), consisting of spontaneous reports on adverse events for post-market drugs are called passive surveillance methods. On the other hand, the statistical signal detection methods for longitudinal data, as the data ...
متن کاملPost Marketing Surveillance: a Real – Life Effectiveness of Essential Medicines in Indian Population
The aim of the work is the need of post marketing surveillance in India. The objective in Postmarketing surveillance is to estimate the strength of the association between adverse events (AEs) and drug exposures that vary over time. In premarketing testing, the numbers and types of patients used to demonstrate a drug’s efficacy and safety are limited compared with the numbers and types of patie...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
دوره 182 1 شماره
صفحات -
تاریخ انتشار 2010