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 through all 7 steps to becoming a reality. Each step is carefully gone through to make sure that the drugs will do good for the population. The First Step in bring a new pharmaceutical to market is called the Preclinical Testing. This is where they will test the drug on animals in labs in order to show its biologically ready, for human trials. They have to figure out dosage amounts, and how the drug itself is actually absorbed into the body.
Now Step two in making a new pharmaceutical is called the Investigational New Drug Application. This form is sent to the FDA after Preclinical Testing, which is a request to start human trial testing. It shows the FDA all the research that was done from the time it was born to the present. If the FDA does not respond within 30 days, they can automatically start with the next step.
Step three is called Phase I Clinical Trials this is where they find 20 to 80 volunteers who are physically healthy to take the medication to report any side effects that they have and determine their safe dosage amounts. This step can actually take about a year to complete. Step four is called Phase II Clinical Trials and on this phase they actually find around 100 to 300 patients that actually suffer from the disease, and are done in a controlled environment....