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The FDA issued a black box warning in September 2010, for tigecycline regarding an increased risk of death compared to other appropriate treatment. [ 26 ] [ 3 ] [ 28 ] As a result of increase in total death rate (cause is unknown) in individuals taking this drug, tigecycline is reserved for situations in which alternative treatment is not suitable.
Glycylcycline antibiotics have a similar mechanism of action as tetracycline antibiotics. They block protein synthesis hence preventing bacterial reproduction. Both classes of antibiotics bind to the 30S ribosomal subunit to prevent the amino-acyl tRNA from binding to the A site of the ribosome.
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports. [1]
Although tigecycline is one of the first lines of defense against carbapenemase-producing isolates, negative clinical outcomes with tigecycline have occurred. Both urinary tract and primary blood infections can make tigecycline ineffective, because it has limited penetration and rapid tissue diffusion after being intravenously infused ...
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
Report generation functionality is almost always present in database systems, [citation needed] where the source of the data is the database itself. It can also be argued that report generation is part of the purpose of a spreadsheet. Standalone report generators may work with multiple data sources and export reports to different document formats.
Easytrieve is a report generator, sold by CA Technologies. [1] [2] Easytrieve Classic and Easytrieve Plus are two available versions of this programming language primarily designed to generate reports and are used by large corporations operating in mainframe (z/OS, z/VM, z/VSE), UNIX, Linux, and Microsoft Windows environments.
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.