Killer Disease on Campus

Student Handout

Development Steps

A: Phase One Clinical Studies
This step is the introduction of a new drug into human subjects, and includes looking at how the drug acts in the human system and what, if any, side effects occur at increasing doses. A very small number of 20-80 people are involved.

B: Synthesis and Purification
Hundreds, or even thousands, of chemical compounds are created and tested to find one that has the desired effect. Modifications continue to take part during later stages.

C: Legally Marketed in United States
After the product labeling has been checked and—if necessary—the manufacturing site visited, if all is in order, approval is given and the drug can be marketed in the United States.

D: New Drug Application
The company developing the drug submits an application including all research and development data.

E: Short-term Animal Testing
In this step, a new drug is tested on animals. This is a short-term method of testing.

F: Phase Two Clinical Studies
During this step scientists decide whether a drug is useful for treatment of the disease being investigated. They want to know what short-term side effects or risks the drug might bring about. Relatively small numbers of people (about 300) are involved.

G: Review Process
The Center for Drug Evaluation and Research reviews all applications. Teams of reviewers include physicians, statisticians, microbiologists, and chemists.

H: Long-term Animal Testing
This step is a long-term test of a new drug on animals in which concerns over birth defects and cancer are investigated.

I: Phase Three Clinical Studies
During this step, researchers collect more information about the effectiveness and safety of the drug to evaluate its risks and benefits. At this level, many people (from about 300 to 3,000) take part in the clinical trials.