The National Gene Vector Biorepository's Pharm/Tox Database.
نویسندگان
چکیده
continuation of the Pharmacology/Toxicology (Pharm/Tox) Database formerly maintained by the National Gene Vector Laboratory. The purpose of the database is to provide gene therapy investigators with a catalog of gene therapy biodistribution and toxicology studies on file with the US Food and Drug Administration (FDA). Pharm/tox refers to any in vitro or animal study that seeks to determine the therapeutic or toxic effect of a drug product (including gene therapy). Pharm/tox studies are designed to estimate the dose and dosing schedule as well as to identify the potential toxicity of drug products before they are administered to humans. These studies, which are required by the FDA, are submitted in an Investigational New Drug (IND) application-the established mechanism for FDA oversight of investigational drug development. The IND application must outline what is known about the drug, how the drug wil be manufactured, the clinical protocol under which the d rug will be administered, and how the patients wil be informed about potential risks; in addition, it must include the results of pharm/tox studies. The type and scope of a pharm/tox study wil depend on several factors,
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عنوان ژورنال:
- Molecular therapy : the journal of the American Society of Gene Therapy
دوره 17 4 شماره
صفحات -
تاریخ انتشار 2009