NAPSRx Practice Questions And 100%
Correct 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 the discovery of an
initial compound to FDA approval? ANSWER 10-15 years
Which one of the following regulatory agencies is industry-based-run mainly by the
companies themselves? ANSWER Pharmaceutical Research and Manufacturers of
America
Which has eased the pharmaceutical R&D process? - ANWER none of these
The FDA Modernization Act of 1997 was a landmark move that made it possible to make
safe and effective new drugs and biologics available sooner to patients. - ANSWER True
According to your text, what is the best method of delivering 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
,Compared with your manual, what did the G10 Medicines Group recently report about
the pharmaceutical industry in the EU? - ANSWER there is poor collaboration between
publicly- and privately-funded research centers
The objective of the preclinical pharmacology studies is to obtain information about the
safety and efficacy of the lead compound. - ANSWER True
Toxicity information in a preclinical program gives confidence regarding a drugs safety
attribute. - ANSWER True
Good Laboratory Practice oversees the pharmacological studies performed on animals.
- ANSWER True
Why do drugs administered to patients contain only APIs? - ANSWER they don't
Which one of the following does not affect the ability of a drug to penetrate membranes?
- ANSWER the drug's vesicles
Through which membranes are lipid-soluble drugs generally able to 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 does 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 the following medical terms means "to apply the drug on the skin surface"? -
ANSWER transdermal
Carcinogenicity studies are conducted to discover the tumor-causing capability 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 of the clinical study phases 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
In case 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 a type of observational study that identifies first a group of
subjects with a certain disease and a control group without the disease and then look
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 of the following measures defines the number of new events occurring in a
Correct 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 the discovery of an
initial compound to FDA approval? ANSWER 10-15 years
Which one of the following regulatory agencies is industry-based-run mainly by the
companies themselves? ANSWER Pharmaceutical Research and Manufacturers of
America
Which has eased the pharmaceutical R&D process? - ANWER none of these
The FDA Modernization Act of 1997 was a landmark move that made it possible to make
safe and effective new drugs and biologics available sooner to patients. - ANSWER True
According to your text, what is the best method of delivering 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
,Compared with your manual, what did the G10 Medicines Group recently report about
the pharmaceutical industry in the EU? - ANSWER there is poor collaboration between
publicly- and privately-funded research centers
The objective of the preclinical pharmacology studies is to obtain information about the
safety and efficacy of the lead compound. - ANSWER True
Toxicity information in a preclinical program gives confidence regarding a drugs safety
attribute. - ANSWER True
Good Laboratory Practice oversees the pharmacological studies performed on animals.
- ANSWER True
Why do drugs administered to patients contain only APIs? - ANSWER they don't
Which one of the following does not affect the ability of a drug to penetrate membranes?
- ANSWER the drug's vesicles
Through which membranes are lipid-soluble drugs generally able to 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 does 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 the following medical terms means "to apply the drug on the skin surface"? -
ANSWER transdermal
Carcinogenicity studies are conducted to discover the tumor-causing capability 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 of the clinical study phases 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
In case 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 a type of observational study that identifies first a group of
subjects with a certain disease and a control group without the disease and then look
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 of the following measures defines the number of new events occurring in a
