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Exam (elaborations)

NAPSR/CNPR Exam With 100% Verified Solutions 2024

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NAPSR/CNPR Exam With 100% Verified Solutions 2024 Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - answerTrue Average review time for a new drug - answer18 months The "engine of innovation," focused on discovering or inventing promising new product. - answerResearch & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - answerManufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. - answerTrue 3,070 new meds are in development for cancer. - answerTrue Define Off-label - answerUsage of a medication for purposes other than the specific ones appearing on the label Toxicity - answerThe extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - answerA 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 - answerInactive pill, liquid, or powder that has no treatment value aka sugar pill Edema - answerSwelling Asymptomatic - answerWithout signs or symptoms Clinical Pharmacology - answerThe study of the effects and movement of drugs in the human body Anatomy - answerThe study of basic structures of the body Physiology - answerThe study of how those body structures function Basic clinical pharmacology involves 3 main concepts - answerPharmacodynamics, Pharmacokinetics, drug distribution and elimination. Pharmacodynamics - answerStudy 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 - answerStudy 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 - answerDrug delivery systems, route of administration , modes of excretion. Plasma - answerThe liquid portion of the blood that carries proteins and other substances Organs - answerSpecialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin) Nucleus - answerBrain of the cell that regulates all activities. Proteins - answerA nutrient made up of of chains of amino acids Fats - answerA nutrient stored in special body tissues as a great source of reserve energy Carbohydrates - answerA nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. Vitamins - answerA nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body. Minerals - answerA nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient - answerTrue Body's Major Systems - answerCardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune Absorption - answerHow the drug passes from its side of administration into the bloodstream Distribution - answerHow the drug is dispersed among the organs after absorption into the blood Metabolism - answerHow the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the ki

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