NAPSRx/CNPR Study Guide-Latest Update

NAPSRx/CNPR Study Guide-Latest Update-The FDA regulates the introduction of new drugs and enforces U.S. drug laws. True 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 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 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. 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. Drug distribution & elimination Drug delivery systems, route of administration , modes of excretion. Plasma The liquid portion of the blood that carries proteins and other substances Nucleus Brain of the cell that regulates all activities. Vitamins A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body. Minerals A nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient True Absorption How the drug passes from its side of administration into the bloodstream Distribution How the drug is dispersed among the organs after absorption into the blood Metabolism How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Excretion 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. It takes about 10 years for a drug to hit the market True 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 Patent last 20 years True Inactive ingredients Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body 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