What is the difference between the phases of a study?
A. Phase I Study Phase I studies studies are concerned with the drug’s safety. This phase of testing is performed on a small number of healthy volunteers. The study is designed to determine what happens to the drug in the human body — how it is absorbed, metabolized, and excreted. A Phase I study also investigates side effects as the dosage level is increased. This initial phase of testing generally takes several months. Phase II Study Phase II studies are concerned with the drug efficacy or effectiveness. This phase is only conducted after the drug is shown to be safe. The second phase of testing can involve several hundred patients. Most Phase II studies are randomized trials. One group of patients will receive the experimental drug while the second “control” group will receive the standard treatment or placebo. These studies are often blinded which means neither the patients nor the researchers know who is getting the experimental drug. When a study is blinded it can provide the ph
