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New Chemical Entity (NCE)

A drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. An NCE is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Synthesis of an NCE is the first step in the process of drug development.
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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
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Argentina: ANMAT - new regulatory update   by  on 2010-05-01 01:40:32
 Subject :Cell Based Reporter Assays vs. Animal Studies in Drug Discovery .. 2012-01-16 12:43:43 
Tonny Johnson
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Cell Based Reporter Assays vs. Animal Studies in Drug Discovery- Potential Limitations, Risks and Liabilities

This blog critically analyzes the potential scientific limitations, risks and liabilities of cell based reporter assays, including non-natural protein based reporter assays (e.g. circularly permuted firefly luciferase or GFP based reporter assays) and stem cell based assays, in drug discovery and development.  Scientific arguments have been put forward to suggest that current format of cell based reporter assays may not be ideal for replacing animal studies. This blog also analyzes the potential negative impact of patents and intellectual property (IP) rights in fostering innovations in cell based assays. Finally, this blog warrants imposing accountability, tighter regulations and demanding higher standards in cell based assays that are used in drug discovery and development. Please follow this link to read the full blog article: http://sciclips.wordpress.com/2012/01/16/cell-based-reporter-assays-vs-animal-studies-in-drug-discovery-potential-limitations-risks-and-liabilities/

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