NPR, NAPSR EXAM QUESTIONS AND 100% ACCURATE ANSWERS ALREADY GRADED A 2025

"abbreviated new drug application (ANDA) - CORRECT ANSWER= the process by which applicants must scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs in the same way as the innovator drug, no duplicate testing (p. 75)" "the Hatch-Waxman Act of 1984 - CORRECT ANSWER= -A.K.A. Drug Price Competition and Patent Restoration Act -made it easier to bring generic drugs to the market by requiring the FDA to only look at bioavailability studies in order to approve an ANDA. -gave protection to the research based manufacturers by providing a 30-month automatic cooling off period once an ANDA is challenged for patent infringement (p. 75)" "Drug Utilization Review (DUR) programs - CORRECT ANSWER= -involve retrospective monitoring of physicians' prescribing patterns -more than 90% of HMOs require DURs -nowadays mostly monitors cost savings (p. 181)" "independent vs dependent variable - CORRECT ANSWER= An independent variable is the one that influences the variation. A dependent variable is the variable being tested and measured in a scientific experiment (the result of applying the independent variable)." “what does a STAT order mean? - CORRECT ANSWER= a drug needed immediately and given only once" "what information does the overdosage section of the labeling provide? - CORRECT ANSWER= signs, symptoms and treatment of acute overdoses" "types of drug-drug interactions: - CORRECT ANSWER= duplication, opposition (antagonism) and alteration (p.51)" "tolerance vs resistance - CORRECT ANSWER= tolerance is the diminished response to a drug; resistance is the cells ability to resist the effects of the drug on them." "four basic transport mechanisms - CORRECT ANSWER= passive diffusion, facilitated diffusion, active transport, and pinocytosis (p. 95)" "the four phases of clinical trials - CORRECT ANSWER= phases I-IV (P. 124-126)" "Key Parts Of A Clinical Paper (5) - CORRECT ANSWER= Abstract, Introduction, methods, results, discussion/conclusions (p. 128-129)" "reliability vs validity - CORRECT ANSWER= reliability = consistency and validity = accuracy (p. 138; 143)" "sampling error vs selection bias - CORRECT ANSWER= sampling error is unbiased and is randomly chosen from the population. selection bias is when the sample was specifically chosen based on particular characteristics (p.142-143)" "opportunity cost - CORRECT ANSWER= based on the premise that all resources are scarce, and therefore every time we choose to use a resource it reduces the possibility of it being used in another way." "what type of DTC advertising is the only legal form in Europe? - CORRECT ANSWER= Disease-state or unbranded ads (provides public information on a disease, not a drug) (p. 223)" "can pharm sales reps offer doctors meals? (PhRMA code) - CORRECT ANSWER= company reps can only offer occasional meals as long as they are modest, and only offered in an office/hospital setting in conjunction with an educational presentation. (p. 228)" "FAQ about the PhRMA code - CORRECT ANSWER= p. 268-274" "Urology and selling to Urologists - CORRECT ANSWER= p. 300-301" "what is a Medical Science Liaison (MLS)? - CORRECT ANSWER= they serve as educators and field-based medical resources. they interface between their company and healthcare leaders." "push through vs pull through sales strategies - CORRECT ANSWER= - push-through refers to the company's overall efforts to demonstrate clinical efficiency and efficacy and cost effectiveness of a product. - pull-through generates demand for the product, usually in ways consistent with the health plans goals and guidelines. (p. 311)" "drug labeling requirements FDA - CORRECT ANSWER= "What is predictive validity? - CORRECT ANSWER= the ability of an indicator to correctly predict an outcome."