NAPSRX PRACTICE QUESTIONS EXAM QUESTIONS WITH
COMPLETE ASNWERS
Which area of R&D has seen the largest cost increases?
clinical trials
On average, how long does a new drug take to be developed (from discovery of
initial compound to FDA approval)?
10-15 years
Which of the following regulatory agencies is industry-based (run mainly by the
companies themselves)?
Pharmaceutical Research and Manufacturers of America (PhRMA)
Which of the following factors has simplified the pharmaceutical R&D process?
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.
True
According to your manual, which type of system is the best way to deliver
healthcare?
a market-based system
How would increased pharmaceutical price controls impact the US healthcare
system?
,increased price controls would stifle innovation
Which of the following invests a greater percentage of sales in research than the
biotech sector?
none of these
What was the intent of the Bayh-Dohl Act and the Stevenson-Wydler Technology
Innovation Act?
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)?
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.
True
Toxicity information in preclinical studies provides confidence about a drugs
safety aspect.
True
Pharmacological studies using animals are regulated under Good Laboratory
Practice.
True
Why do drugs administered to patients only contain APIs?
they don't
Which of the following does not affect a drug's ability to permeate membranes?
the drug's vesicles
, Through which barriers can lipid-soluble drugs usually pass?
cell membranes
How are weak acid drugs generally absorbed by the stomach?
more quickly than weak basic drugs
Which of the following routes of administration do NOT completely bypass the
liver?
rectal administration
Why are intravenous drug dosages easier to control than drugs administered
transdermally?
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?
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"?
transdermal
Carcinogenicity studies are carried out to identify the tumor-causing potential of
a drug.
True
According to NIH ethical guidelines, which of the following is the most important
criteria in selecting subjects for clinical studies?
scientific objectives
Which statement about the IRB is incorrect?
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?
COMPLETE ASNWERS
Which area of R&D has seen the largest cost increases?
clinical trials
On average, how long does a new drug take to be developed (from discovery of
initial compound to FDA approval)?
10-15 years
Which of the following regulatory agencies is industry-based (run mainly by the
companies themselves)?
Pharmaceutical Research and Manufacturers of America (PhRMA)
Which of the following factors has simplified the pharmaceutical R&D process?
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.
True
According to your manual, which type of system is the best way to deliver
healthcare?
a market-based system
How would increased pharmaceutical price controls impact the US healthcare
system?
,increased price controls would stifle innovation
Which of the following invests a greater percentage of sales in research than the
biotech sector?
none of these
What was the intent of the Bayh-Dohl Act and the Stevenson-Wydler Technology
Innovation Act?
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)?
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.
True
Toxicity information in preclinical studies provides confidence about a drugs
safety aspect.
True
Pharmacological studies using animals are regulated under Good Laboratory
Practice.
True
Why do drugs administered to patients only contain APIs?
they don't
Which of the following does not affect a drug's ability to permeate membranes?
the drug's vesicles
, Through which barriers can lipid-soluble drugs usually pass?
cell membranes
How are weak acid drugs generally absorbed by the stomach?
more quickly than weak basic drugs
Which of the following routes of administration do NOT completely bypass the
liver?
rectal administration
Why are intravenous drug dosages easier to control than drugs administered
transdermally?
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?
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"?
transdermal
Carcinogenicity studies are carried out to identify the tumor-causing potential of
a drug.
True
According to NIH ethical guidelines, which of the following is the most important
criteria in selecting subjects for clinical studies?
scientific objectives
Which statement about the IRB is incorrect?
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?
