Professor: Matthew Maddox
By: Lisa Brockman
In my paper I will be discussing a few different types of New Pharmaceuticals on the market today. I will also be discussing how the drugs are tested, made, and how much of a cost it is to make a new drug. We start with the FDA who created CDER (Center for Drug Evaluation and Research). Their Purpose is to make sure drugs are safe and effectively. They do not actually do the testing themselves but are responsible for the research on the drug to test quality, safeness, and effectiveness.
To actually bring a new drug to market it can take up to 12 years, and there is actually only a 1 in 5,000 chance that it will make it ...view middle of the document...
Usually lasting around two years.
Our next step is Phase III Clinical Trials, which is where they find around 1,000 to 3,000 volunteers who are found in clinics and hospitals. It is a more extensive phase than phase II was. They take all that they have learned from the earlier phases to determine if there is any effectiveness in the drug at all. All volunteers are to report any side effects. Phase III can last up to three years to complete.
Now that Phase I to III have been completed the company must now file a New Drug Application (NDA). This form is filled with information containing the results of the Clinical Trials. They then turn it into the FDA for review, and they ultimately decide on whether or not the drug can come to pass. This form can take around two to two and a half years to process.
Our last and final step is Phase IV Studies This consists of data gathered from patients, who get to share their own experience and symptoms with the FDA themselves. Making a New Pharmaceutical is very costly. (Donald Light, a Professor and expert on the pharma business model, sand that while companies claim each drug costs them $1.2 billion, the...