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How are drugs tested?

Drug testing is guided by U.S. laws and regulations. Availing to such guidelines, a drug must go through a number of different testing phases to prove that it is both effective for the targeted medical condition and is safe for use in patients. The first step in a drug’s development process is laboratory investigation, where extensive chemical and animal studies are conducted to gain an understanding of how the drug works. Next, the medication is evaluated for safety in a small group of healthy human volunteers. If test results prove satisfactory, the drug is tested on a small number of patients with the targeted condition, to determine actual benefit.

Medication Testing: Advanced Clinical Trials

If these rigorous screening steps are passed successfully, a new medication enters the third phase of human drug testing – advanced clinical trials. In Phase III studies, a significant number of patients with the targeted condition are given the investigational treatment to evaluate its effectiveness, dosages and side effects on a large-scale basis. After all of these phases of research are successfully completed, a new drug application is prepared and submitted for review by the U.S. Food and Drug Administration (FDA). If the drug or treatment is determined to be safe and effective, it is given FDA marketing approval.

Medication Testing: The Final Steps

Before a clinical research study can be initiated at a hospital or institution, the way, or protocol, by which it will be conducted must first be reviewed by the FDA and an Institutional Review Board (IRB). An IRB is a group of both medical and non-medical representatives of the community who review human medical research studies to assess potential benefits and risks and to ensure that participants are fully informed. The drug testing process ultimately ensures the efficacy and safety of medications as treatments for human conditions.

Common Questions:

What are Clinical Research Trials?
Why Participate in a Clinical Study?
What’s the difference between a Clinical Trial and Treatment?

Learn About Clinical Studies:

Florida Clinical Research Resources
Types of Clinical Research Trials
Phase I Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials
Phase IV Clinical Trials
Clinical Trial Glossary
Clinical Trials History

Understand Your Rights:

Patient Rights
Patient Privacy
Informed Consent
NIH Patient Bill of Rights
Legal, Ethical & Safety Issues