NAPSRx Exam: NAPSRx Quiz 1:NAPSRx Exam: NAPSRx Practice
Questions & Answers
Which area of R&D has seen the largest cost increases? - ANSWER:clinical trials
On average, how long does a new drug take to be developed (from discovery of initial compound to FDA
approval)? - ANSWER:10-15 years
Which of the following regulatory agencies is industry-based (run mainly by the companies themselves)?
- ANSWER:Pharmaceutical Research and Manufacturers of America (PhRMA)
Which of the following factors has simplified the pharmaceutical R&D process? - 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. - ANSWER:True
According to your manual, which type of system is the best way to deliver healthcare? - ANSWER:a
market-based system
How would increased pharmaceutical price controls impact the US healthcare system? -
ANSWER:increased price controls would stifle innovation
Which of the following invests a greater percentage of sales in research than the biotech sector? -
ANSWER:none of these
What was the intent of the Bayh-Dohl Act and the Stevenson-Wydler Technology Innovation Act? -
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)? - 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. - ANSWER:True
Toxicity information in preclinical studies provides confidence about a drugs safety aspect. -
ANSWER:True
Pharmacological studies using animals are regulated under Good Laboratory Practice. - ANSWER:True
Why do drugs administered to patients only contain APIs? - ANSWER:they don't
Which of the following does not affect a drug's ability to permeate membranes? - ANSWER:the drug's
vesicles
Through which barriers can lipid-soluble drugs usually pass? - ANSWER:cell membranes
How are weak acid drugs generally absorbed by the stomach? - ANSWER:more quickly than weak basic
drugs
, Which of the following routes of administration do NOT completely bypass the liver? - ANSWER:rectal
administration
Why are intravenous drug dosages easier to control than drugs administered transdermally? -
ANSWER:The 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? - ANSWER:all 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"? - ANSWER:transdermal
Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. - ANSWER:True
According to NIH ethical guidelines, which of the following is the most important criteria in selecting
subjects for clinical studies? - ANSWER:scientific objectives
Which statement about the IRB is incorrect? - ANSWER:The 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? - ANSWER:Phase 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? - ANSWER:surrogate
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? - ANSWER:case-control study
Which measure of central tendency is the sum of all observations divided by the number of
observations? - ANSWER:mean
Which measurement describes the number of new events that occur during a specified period of time in
a population at risk for the event? - ANSWER:incidence
Which of the following measures is used to describe variability of the population mean? -
ANSWER:standard error of the mean
Which of the following terms denotes the extent to which a test actually measures what it is supposed to
be measuring, or what we think it is measuring? - ANSWER:validity
What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - ANSWER:methods of
survival analysis
Which section of a clinical paper describes subjects' entry and exclusion criteria? - ANSWER:methods
Which document sets how a trial is to be conducted (ie the study's general design and operating
features)? - ANSWER:protocol
When designing and performing clinical trials, several ethical constraints must be considered. Which of
the following is NOT one of these ethical constraints? - ANSWER:geographic variations
Questions & Answers
Which area of R&D has seen the largest cost increases? - ANSWER:clinical trials
On average, how long does a new drug take to be developed (from discovery of initial compound to FDA
approval)? - ANSWER:10-15 years
Which of the following regulatory agencies is industry-based (run mainly by the companies themselves)?
- ANSWER:Pharmaceutical Research and Manufacturers of America (PhRMA)
Which of the following factors has simplified the pharmaceutical R&D process? - 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. - ANSWER:True
According to your manual, which type of system is the best way to deliver healthcare? - ANSWER:a
market-based system
How would increased pharmaceutical price controls impact the US healthcare system? -
ANSWER:increased price controls would stifle innovation
Which of the following invests a greater percentage of sales in research than the biotech sector? -
ANSWER:none of these
What was the intent of the Bayh-Dohl Act and the Stevenson-Wydler Technology Innovation Act? -
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)? - 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. - ANSWER:True
Toxicity information in preclinical studies provides confidence about a drugs safety aspect. -
ANSWER:True
Pharmacological studies using animals are regulated under Good Laboratory Practice. - ANSWER:True
Why do drugs administered to patients only contain APIs? - ANSWER:they don't
Which of the following does not affect a drug's ability to permeate membranes? - ANSWER:the drug's
vesicles
Through which barriers can lipid-soluble drugs usually pass? - ANSWER:cell membranes
How are weak acid drugs generally absorbed by the stomach? - ANSWER:more quickly than weak basic
drugs
, Which of the following routes of administration do NOT completely bypass the liver? - ANSWER:rectal
administration
Why are intravenous drug dosages easier to control than drugs administered transdermally? -
ANSWER:The 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? - ANSWER:all 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"? - ANSWER:transdermal
Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. - ANSWER:True
According to NIH ethical guidelines, which of the following is the most important criteria in selecting
subjects for clinical studies? - ANSWER:scientific objectives
Which statement about the IRB is incorrect? - ANSWER:The 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? - ANSWER:Phase 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? - ANSWER:surrogate
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? - ANSWER:case-control study
Which measure of central tendency is the sum of all observations divided by the number of
observations? - ANSWER:mean
Which measurement describes the number of new events that occur during a specified period of time in
a population at risk for the event? - ANSWER:incidence
Which of the following measures is used to describe variability of the population mean? -
ANSWER:standard error of the mean
Which of the following terms denotes the extent to which a test actually measures what it is supposed to
be measuring, or what we think it is measuring? - ANSWER:validity
What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - ANSWER:methods of
survival analysis
Which section of a clinical paper describes subjects' entry and exclusion criteria? - ANSWER:methods
Which document sets how a trial is to be conducted (ie the study's general design and operating
features)? - ANSWER:protocol
When designing and performing clinical trials, several ethical constraints must be considered. Which of
the following is NOT one of these ethical constraints? - ANSWER:geographic variations
