How are drugs tested?

Guided by U.S.A. laws and regulations, 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 with 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 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. If these rigorous screening steps are passed successfully, a new medication enters the third phase of testing – advanced clinical trials. In phase III studies, a large number of patients with the targeted condition are given the investigational treatment to evaluate its effectiveness, dosage and side effects. After all these phases of research are successfully completed, a new drug is prepared and submitted for review by the US Food and Drug Administration (FDA). If the drug is determined to be safe and effective, it is given FDA marketing approval. Before a clinical research study can be initiated at a hospital or an institution, the protocol which describes the procedures by which it will be conducted must first by reviewed by the FDA and an Institutional Review Board (IRB). And IRB is a group of both medical and non medical representatives of the community who review proposed research studies to assess potential benefits and risks and to insure that the study is safe, that participants are protected and fully informed.