The FDA regulates the introduction of new drugs and enforces U.S. drug laws. True Pharma companies mustsubmit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. True Average review time for a new drug 18 months Define Off-label Usage of a medication for purposes other than the specific ones appearing on the label Toxicity The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) A committee of physicians,staticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin. Placebo Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema Swelling Asymptomatic Without signs orsymptoms Clinical Pharmacology The study of the effects and movement of drugs in the human body Basic clinical pharmacology involves 3 main concepts Pharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics