Drug Development with Kim Bruce

BY: Coral Opittek

FDA

The FDA is the U.S. Food and Drug administration. The FDA is where the the drug is evaluated before the drug can be sold. CDER makes sure that drugs are safe for humans to use and work correctly. The FDA is most involved in the final phase of drug development by getting approved

How are drugs helpful to humans? Drugs can be used for many things such as killing cancer cells, stopping illnesses/diseases from spreading and or can get rid of the illnesses/diseases, they can help someone recover from an injury, pain medication.

Development The steps to the process:

discovery First scientists have to choose what the drug will be used for such as a specific disease. About 5,000 to 10, 000 molecules are tested/screened. Then the scientists agree that is the leading compound of that particular drug. Last it is reviewed and then one or more compounds are added.

Testing the drug The drug is tested in different ways the second testing the drug is finally being tested by people that are healthy and are volunteers. The third testing is done by a small group of patients the fourth is a big group of patients

Funfacts Development can take up to 15 years! Costs up to billions of dollars to develop a drugvery long processFDA is involved to keep the drug safe

A drug entering the U.S. market

In the U.S. A drug entering the market is a very long process and not every single drug scientists produce comes into the market. A drug coming into the market has a very low percentage.

Conclusion Developing a drug is very time consuming as well as spending a lot of money. The drug goes through many testing stages for humans safety and to make sure that the drug does what the scientists wanted it to do. Once the drug is finally developed it is helpful to all of the people that need it.

Recognition Cancergrace.orgMedicine.uab.edu

Kim Bruce: University of WashingtonChildren’s Hospital