NAPSR-CNPR Exam QUESTIONS AND ANSWERS VERIFIED 100% | LATEST UPDATE, Exams of Nursing

Download NAPSR-CNPR Exam QUESTIONS AND ANSWERS VERIFIED 100% | LATEST UPDATE and more Exams Nursing in PDF only on Docsity! NAPSR-CNPR Exam QUESTIONS AND ANSWERS VERIFIED 100% | LATEST UPDATE 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, stasticians, 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. Seven rights of drug administration pg 30 Bioavailability how quickly and how much of a drug reaches its intended target site of action Bioequivalent when they contain the same active ingredients and proceed virtually the same blood levels over time. Therapeutic equivalence Production of the same medicinal effect Drug elimination and Excretion pg 34 Drug Forms Pg 35-38 Patent last 20 years True Inactive ingredients Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body Pharmaceutical Ingredients Pg 54 BID twice a day Cmax Peak plasma concentration on a measuring curve Half-life Period of time it takes for a specific amount of drug in the body to be reduced, through the excretion or elimination process, to exactly one-half that original amount PRN As needed QD Once a day QID Four times a day Protein binding the ability of certain drugs to bind to plasma protein. TID three times a day Titration the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects Tmax Time of peak plasma concentration on a measuring curve STAT Immediately Primary wholesale distributors Buy most of their drugs directly from manufacturers. Legally considered authorized distributors within the meaning of the PDMA because they usually have ongoing relationships with manufacturers Secondary wholesale distributors Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered authorized distributors of the manufacturers within the meaning of the PDMA True Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be subjected to extremes of temperature, moisture, and contamination True A sample closet or cabinet is essentially similar to a grocery store shelf. The more visibility you can give your drug, the more likely it will be used. True In some situations, a physician may sign the paperwork before the number of samples has been recorded True Section 503 Prohibits sale, purchase, or trade of drug samples E-sampling Pg 72 Many pharmaceutical manufacturers set expiration dates every six months (June, December) True DEA regulates the distribution and use of narcotics and other controlled substances True FTC Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior AMA provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies Benefits of Government-Industry Partnerhsips Pg 79 Preclinical studies pg 81 Pinocytosis Involves the engulfing of fluids by a cell. Transport Mechanisms Passive diffusion, facilitated diffusion, active transport, pinocytosis Absorption methods Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous The liver is the major organ for metabolizing drugs. Secondary is kidney True CL= rate of drug elimination/drug concentration in blood True In vitro assays are increasingly being see because they are usually less expensive, offer more rapid results, and are not as prone to negative publicity. True Clinical Trials pg 89 Subjects should be informed about the aims, methods, risks, and benefits of the trial True Four phases of clinical trials Pg 90 Regulatory Requirement terms Pg 92