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Glial Derived Neurotrophic Factor - Essay Example

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The life of a drug from conception to FDA approval can be a rigorous test and is continually subjected to many unknown vulnerabilities. The mechanism of the drug's action is considered and the results of animal tests are evaluated. Small-scale human trials are conducted to measure tolerance, dosage, safety, and side effects…
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Glial Derived Neurotrophic Factor
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Download file to see previous pages Glial Derived Neurotrophic Factor (GDNF) is a naturally occurring protein found in the brain and there is evidence that GDNF is necessary for normal neuromuscular development and survival. In 1994 Amgen Inc. acquired the patent for synthetic GDNF. After a series of animal trials and pre-clinical trials, Phase-I trials began in 2001-2002 in the UK and at the University of Kentucky. These trials showed significant improvement for the participants and researchers at Bristol UK remarked, "Within a couple of months, patients were noticing dramatic improvements in their ability to move". Similar results were reported from the Kentucky trials, which noted, "...there appeared to be bilateral improvements, including improved postural stability [...] evidence of improved affect and fine motor control and speed". GDNF appeared to be a promising breakthrough.
Based on the previous favorable results, Amgen initiated Phase-II trials involving 34 patients in 2003. However, by 2004 GDNF had been shown to cause brain lesions in primate tests and Amgen immediately halted the testing. It was noted by researchers that the primates had been given a dose 10 times that of the human participants and there was overwhelming evidence that the lesions were caused by the sudden withdrawal of GDNF. ...Download file to see next pagesRead More
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