NAPSRx Exam Study Guide Questions And Answers Verified 100% Correct

NAPSRx Exam Study Guide Questions And Answers Verified 100% Correct Legally, bioequivalence of different versions of a drug can vary by up to ________. - ANSWER 20% which of the following statements about biologics is incorrect - ANSWER they do not cause immune response what are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers - ANSWER agonists Which term denotes how an API works in the body? - ANSWER mechanism of action What cements the active and inert components together to maintain cohesive portions? - ANSWER binders what does the medical abbreviation "BID" denote - ANSWER twice a day what is the medical abbreviation for "as needed" - ANSWER PRN what components might cause patients' different reactions to brand name and generic drugs - ANSWER differences in inactive ingredients all cells have a nucleus - ANSWER false which of the following does not affect drig response - ANSWER the patients' genetic makeup, age, body size, and use of other drugs and dietary supplements, the patient's other conditions or diseases, whether or not the patient takes the drug properly drug reactions are predictable becasue they do not occur after a person has been previously exposed to the drug one or more times without any allergic reactions - ANSWER false what is the typical relationship between a drug's site of administration and site of action - ANSWER they are usually somewhat removed from each other "large molecules" products are developed and manuffactured by a chemical process - ANSWER false what is CMAX - ANSWER Peak plasma concentration on a measuring curve which of the following is not a main concept in clinical pharmacology - ANSWER pharmacoprocesses which of the following is not a route of drug administration - ANSWER transfugal How are intradermal drugs delivered? - ANSWER by injection under the skin what is an example of intravenous drug delivery - ANSWER an injection of anesthetic directly into the bloodstream what are the major organs of the gastrointestinal system - ANSWER the mouth, esophagus, stomach, liver, pancreas, gallbladder, small intestine, large intestine who is normally responsible for selling to distributors - ANSWER NAMs How often do secondary drug wholesale distributors buy their drugs directly from manufactures? - ANSWER sometimes By FDA law, large chain pharmacies are not allowed to buy directly from drug manufactures. - ANSWER false Only 3 companies account for nearly 90% of all drug wholesale sales. - ANSWER true what type of sale bypasses the need for intermediary distributors - ANSWER manufacturer- direct sales what is a group purchasing organization (GPO) - ANSWER an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members Prescriptions dispensed by mail-order pharmacies are, on average, around ____________ than those dispensed by retail pharmacies. - ANSWER 3 times larger which of the following is not a type of non-stock sale - ANSWER brokerage sales, dock- to-dock sales, drop shipments what is another term for rebates - ANSWER after-market arrangements the PDMA is the presciption drug manufacturers association - ANSWER false a company that owns and operates three or fewer pharmacies is an - ANSWER independent drug store which section of a drug's package insert infformation covers the usual dosage range - ANSWER indications and usage Drug labels must include indications and usage information, as well as contraindications. - ANSWER true what should be included in the "description" section off a drug's package insert information - ANSWER the drug's proprietary name and the established name Exclusivity gives exclusive _____, is granted by the FDA, and can run concurrently with a patent or not. - ANSWER marketing rights what differentiates exclusivity from a patent - ANSWER Exclusivity is only granted upon the drug's FDA approval. what is required of an invention for it to be worthy of patent protection - ANSWER it must be novel, useful, and not obvious a generic drug is ___ to the originator brand-name drug in dosage, strength, safety, and quality - ANSWER bioequivalent which of the following is not required by the FDA's Criteria for Equivalency - ANSWER the drugs contain identical amounts off the same inactive ingredients A generic drug is ____ to the originatory brand-name drug in dosage, strength, safety, and quality - ANSWER bioequivalent what list is generally considered the most reliable source of information on therapeutically equivalent drug products - ANSWER "approved drug products with therapeutic equivalence" which of the following is an Orange Book rating - ANSWER AA what is the term for chemical equivalents which, when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels - ANSWER biological equivalents