Developing New Drugs Essay

1510 Words Nov 30th, 2013 7 Pages
The Business of Developing New DrugsThe Business of Developing New Drugs for Cancer
Larry Cephas
Strayer University
Developing new drugs for cancer and or any other medical purpose is a tedious, complex, expensive process. The process in developing new drugs involves numerous stages of trial and error. According to Mahajan and Gupta (2010) on average it can cost anywhere from US$ 802million to US$ 1billion dollars to successfully develop and market new drugs and, that process can take up to 12years with on average of only 8% of them ever hitting the market. From the beginning of civilization, people have been concerned regarding the quality and safety of medicines, which I do not fault anyone because, some medicines just do not work
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The next step is applying for an Investigational New Drug Application (IND). If the Food and Drug Administration (FDA) approves the IND within thirty days, the IND becomes affective giving pharmaceutical companies the green light to start testing the potential new drugs on humans. Once steps one-four have been accomplished we move to the fifth step which is the clinical trials. Here there are three phases that must take place and be successful. In Phase1 the drug is given to approximately 20-80 healthy volunteers to be studied to see if there is any potential toxicity in the people. Once this process is successful after one year we move on to Phase II. Phase II trials the drug is than given to 100-300 volunteers with the disease so that they can study and determined the drug effectiveness, and Phase II can take up too two years to be completed before moving on to Phase III. After Phase 1 and II are successfully completed Phase III can begin were now 1,000-5,000 volunteers with the disease that are in hospitals and clinics are given the drug. Here doctors monitor closely to determine the effects of the drug and if any the side effects, and Phase III will determine if the drug is safe and ready. After all the clinical phases have been completed successfully the pharmaceutical company than can proceed with the

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