NAPSR/CNPR Exam 2023 with 100% correct answers

Pharma companies must submit 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 Sales Team Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. True 3,070 new meds are in development for cancer. True 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 or symptoms Clinical Pharmacology The study of the effects and movement of drugs in the human body Anatomy The study of basic structures of the body Physiology The study of how those body structures function Basic clinical pharmacology involves 3 main concepts Pharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics Study of the biochemical and physiological effects of drugs and their mechanisms of action i.e. the study of what a drug does to the body. It describes the therapeutic effects of drugs (pain relief, blood pressure reduction, their side effects and their sites of action.