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Drug Development Process - Essay Example
Pages 6 (1506 words)
Drug development is the process by which new therapies are created and brought to market to treat diseases. Drug should undergo a process before it will be able to approve by the Food and Drug Administration (FDA) and before it will be marketed. The Food and Drug Administration ensures the safety and efficacy of the drug being marketed…
Each step should follow the guidelines provided by the Food and Drug Administration. Product for development which has been marketed or studied previously will undergo the same steps. According to the February 1993 report by the Congressional Office of Technology Assessment, one company costs $359 million in U.S. To be able to get one new medicine from the laboratory testing to the pharmacist's shelf, the process usually takes 12 years on the average and only 5 in 5,000 will make it to human testing. And only one of the 5 will be approved.(FDAreview.org)..
The first step is to analyze the target to be developed. Before developing a drug, you must identify first the state of the disease and the symptoms to which the development of drug will be base to. It is important to identify the target. The key decision if whether the target for therapeutic intervention is one that will have a positive effect on managing the disease in question. There are some companies who want to further develop their product. For example, a drug for diabetes will be developed; the company should specify what would be the added pharmacological action on their drug. This will be the basis for the clinical testing that the new product should undergo.
Metabolic pathway is a new approach in addressing and developing enhanced disease, understanding platforms with the potential to design si ...
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