NAPSR/CNPR EXAM - 14TH EDITION WITH COMPLETE VERIFIED SOLUTIONS 2024.

True or False? The FDA regulates the introduction of new drugs and enforces U.S. drug laws. True True or False? Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. True Brainpower Read More 0:03 / 0:15 What is the average review time for a new drug? 18 months Sales Team (pg 7) Pg 7 What is considered the "engine of innovation," focused on discovering or inventing promising new product? Research & Development (R&D) What includes the supply chain, manufacturing, trade, and distribution functions of the business? Manufacturing & Operations True or False? In 2012, FDA regulators approved 39 new drugs for use in the U.S. True True or False? 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 Define "Toxicity" The extent, quality, or degree to which a substance is poisonous or harmful to the body What is the 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. Define "Placebo" Inactive pill, liquid, or powder that has no treatment value aka sugar pill Define "Clinical Pharmacology" The study of the effects and movement of drugs in the human body 3 Main Concepts of Basic Clinical Pharmacology - Pharmacodynamics - Pharmacokinetics - Drug Distribution and Elimination Define "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. Define "Pharmacokinetics" 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. ADME Define "Drug Distribution & Elimination" - Drug delivery systems - Route of administration - Modes of excretion Define "Plasma" The liquid portion of the blood that carries proteins and other substances Define "Organs" Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin) Define "Nucleus" Brain of the cell that regulates all activities. Define "Proteins" A nutrient made up of of chains of amino acids Define "Fats" A nutrient stored in special body tissues as a great source of reserve energy Define "Carbohydrates A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. Define "Vitamins" A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body. Define "Minerals" A nutrient necessary for bodily purposes such as the balance of body fluid True or False? Water is a nutrient False Water is NOT a nutrient List the Body's Major Organ Systems 1. Cardiovascular 2. Respiratory 3. Gastrointestinal 4. Nervous 5. Musculoskeletal 6. Reproductive 7. Immune Define "Absorption" in ADME How the drug passes from its side of administration into the bloodstream Define "Distribution" in ADME How the drug is dispersed among the organs after absorption into the blood Define "Metabolism" in ADME How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Define "Excretion" in ADME How the drug is eliminated from the body. Usually drugs are eliminated via urine. They can also be excreted through the lungs, skin, or breast milk. True or False? It takes about 5 years for a drug to hit the market False It takes about 10 years for a drug to hit the market Routes of drug administration (pg 36-38) Pg 36-38 Rights of drug administration (pg 32) pg 32 Define "Bioavailability" how quickly and how much of a drug reaches its intended target site of action Define "Bioequivalent" when two drugs contain the same active ingredients and proceed virtually the same blood levels over time.