Subscribe / Unsubscribe for KRC Inc. Newsletters Frequently asked questions Question: Samples of good answers?
Samples of good answers: In order to give you some idea what do we expect from you, let me show some samples of good answers: WhyPhaseIIisNotEnough: Why completion of phase II is not sufficient to gain permission to place the drug on the market? The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people: PHASE I studies are primarily concerned with assessing the drug’s safety. 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 will investigate side effects that occur as dosage levels are increased. PHASE II studies are also designed to evaluate the effectiveness of the drug. One group of patients will receive the experimental drug, while a second “control” group will receive a standard treatment or placebo. The study can provide the pharmaceutical company and the FDA comparative information about the relative safety of th
