NAPSRx Practice Exam Questions With 100% Correct Answers

NAPSRx Practice Exam Questions With 100% Correct Answers Which area of R&D has seen the largest cost increases? - answerclinical trials On average, how long does a new drug take to be developed (from discovery of initial compound to FDA approval)? - answer10-15 years Which of the following regulatory agencies is industry-based (run mainly by the companies themselves)? - answerPharmaceutical Research and Manufacturers of America (PhRMA) Which of the following factors has simplified the pharmaceutical R&D process? - answernone of these The landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients. - answerTrue According to your manual, which type of system is the best way to deliver healthcare? - answera market-based system How would increased pharmaceutical price controls impact the US healthcare system? - answerincreased price controls would stifle innovation Which of the following invests a greater percentage of sales in research than the biotech sector? - answernone of these What was the intent of the Bayh-Dohl Act and the Stevenson-Wydler Technology Innovation Act? - answerto hasten the commercialization of technologies that otherwise might not be used According to your manual, what did the G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)? - answerthere is poor collaboration between publicly- and privately-funded research centers The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. - answerTrue Toxicity information in preclinical studies provides confidence about a drugs safety aspect. - answerTrue Pharmacological studies using animals are regulated under Good Laboratory Practice. - answerTrue Why do drugs administered to patients only contain APIs? - answerthey don't Which of the following does not affect a drug's ability to permeate membranes? - answerthe drug's vesicles Through which barriers can lipid-soluble drugs usually pass? - answercell membranes How are weak acid drugs generally absorbed by the stomach? - answermore quickly than weak basic drugs Which of the following routes of administration do NOT completely bypass the liver? - answerrectal administration Why are intravenous drug dosages easier to control than drugs administered transdermally? - answerThe entire dose is available in the bloodstream to be delivered to the target site Which of the following do not affect a drug's distribution to its target tissues? - answerall of these affect a drug's distribution to its target tissues Which of these medical terms means "to apply the drug on the skin's surface"? - answertransdermal Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. - answerTrue According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies? - answerscientific objectives Which statement about the IRB is incorrect? - answerThe members of the IRB/IEC must be experts in the topic of the study Which phases of clinical studies are open label and which are blinded? - answerPhase I and IV are often open label, Phase II and III are double-blinded or at least blinded If it is not possible to measure the direct effects of a drug, what is used instead? - answersurrogate markers such as blood pressure and cholesterol levels Which of the following is an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time (via chart reviews) to find exposure to risk factors? - answercase-control study Which measure of central tendency is the sum of all observations divided by the number of observations? - answermean Which measurement describes the number of new events that occur during a specified period of time in a population at risk for the event? - answerincidence