NAPSR/CNPR Certification Exam study guide

NAPSR/CNPR Exam Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - Ans True Average review time for a new drug - Ans 18 months Sales Team - Ans Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - Ans Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - Ans Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. - Ans True 3,070 new meds are in development for cancer. - Ans True Define Off-label - Ans Usage of a medication for purposes other than the specific ones appearing on the label Toxicity - Ans The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - Ans 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 - Ans Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema - Ans Swelling Asymptomatic - Ans Without signs or symptoms Clinical Pharmacology - Ans The study of the effects and movement of drugs in the human body Anatomy - Ans The study of basic structures of the body Physiology - Ans The study of how those body structures function Basic clinical pharmacology involves 3 main concepts - Ans Pharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics - Ans 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. Pharmacokinetics - Ans Study of how a drug is processed by the body, with emphasis on the time required for absorption, duration of action, distribution, and method of excretion. The study of how the body affects drugs. Drug distribution & elimination - Ans Drug delivery systems, route of administration , modes of excretion.