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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.
Tigecycline, sold under the brand name Tygacil, is a tetracycline antibiotic medication for a number of bacterial infections. [ 3 ] [ 6 ] [ 7 ] It is a glycylcycline class drug that is administered intravenously.
Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act. Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them.
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]
Version 3.0 was released in 2011. [8] This version contained 1424 approved small molecule drugs and 132 biotech drugs as well as >4000 unique drug targets. Version 3.0 also included drug transporter data, drug pathway data, drug pricing, patent and manufacturing data as well as data on >5000 experimental drugs. Version 4.0 was released in 2014. [4]
Case Report Tabulation Data Definition Specification (CRT-DDS) Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf". Clinical Data Acquisition Standards Harmonization (CDASH) [6] Defines a minimal data collection set for sixteen safety SDTM Domains, harmonizing element names, definitions and ...
Version 8.1.01 Therapeutic Target Database ( TTD ) is a pharmaceutical and medical repository [ 1 ] constructed by the Innovative Drug Research and Bioinformatics Group (IDRB) at Zhejiang University, China and the Bioinformatics and Drug Design Group at the National University of Singapore .
PrecisionFDA is an open-source, cloud-based platform for collaborating and testing bioinformatics pipelines and multi-omics data. [4] [5] PrecisionFDA is available to all innovators in the field of multi-omics, including members of the scientific community, diagnostic test providers, pharmaceutical and biotechnology companies, and other constituencies such as advocacy groups and patients.