NAPSRx Practice Questions Exam Questions with Correct Answers

Which area of R&D has seen the largest cost increases? Correct Answer clinical trials On average, how long does a new drug take to be developed (from discovery of initial compound to FDA approval)? Correct Answer 10-15 years Which of the following regulatory agencies is industry-based (run mainly by the companies themselves)? Correct Answer Pharmaceutical Research and Manufacturers of America (PhRMA) Which of the following factors has simplified the pharmaceutical R&D process? Correct Answer none 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. Correct Answer True According to your manual, which type of system is the best way to deliver healthcare? Correct Answer a market-based system How would increased pharmaceutical price controls impact the US healthcare system? Correct Answer increased price controls would stifle innovation Which of the following invests a greater percentage of sales in research than the biotech sector? Correct Answer none of these What was the intent of the Bayh-Dohl Act and the Stevenson-Wydler Technology Innovation Act? Correct Answer to 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)? Correct Answer there 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. Correct Answer True Toxicity information in preclinical studies provides confidence about a drugs safety aspect. Correct Answer True Pharmacological studies using animals are regulated under Good Laboratory Practice. Correct Answer True