NAPSR/CNPR Certification Exam study guide

NAPSR/CNPR Certification Exam study guide 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 act