PHR 2500 Final Test Questions with Verified
Correct Answers
9 years market exclusivity instead of 5 years
Which of the following is NOT an incentive of the orphan drug designation?
a.) 9 years market exclusivity instead of 5 years
b.) The possibility of the drug company receiving new grants
c.) Tax credits to the drug company
A biologic is not a type of drug according to the FDA definition of a drug
A biologic can be a range of product types. The following is FALSE regarding biologic?
a.) One example of a biologic active ingredient is a vaccine
b.) A biologic is not a type of drug according to the FDA definition of a drug
c.) Biologics include proteins, which may be derived from living systems
d.) Biologics differ from small molecule drugs such as aspirin in both size and complexity
The drug must first be approved as an Investigational New Drug (IND)
Prescription drugs need to first undergo experimentation in preclinical and clinical studies.
Before a drug can enter clinical studies:
a.) The pharmaceutical company must submit a New Drug Application (NDA)
b.) The drug’s active ingredient must be approved by the FDA as a new chemical entity
(NCE)
c.) The drug must first be approved as an Investigational New Drug (IND)
,d.) The drug must show efficacy in humans
Absorption, Distribution, Metabolism and Excretion
What are the 4 parameters that predict the pharmacological profile of a drug?
a.) Absorption, Distribution, Metabolism and Excretion
b.) Adherence, Dispersal, Medication and Elimination
c.) Absorption, Dispersal, Management and Elimination
d.) Application, Distribution, Management and Expulsion
A trial that enrolls patients with the same cancer, but different genetic mutations to
look for potential treatments
What is an umbrella study?
a.) A trial that enrolls patients with multiple cancer types, but a similar genetic mutation to
look for potential treatments
b.) A trial that enrolls patients with the same cancer, but different genetic mutations to look
for potential treatments
c.) A trial that enrolls patients who do not currently have a disease, but are at risk of
developing the disease to study early intervention
d.) A trial in which a group of subjects are followed for long periods of time to watch for a
specific outcome, such as development of a disease
A single-blind interventional study
A phase 3 clinical trial has just begun for the new drug, Buckeyecillin. The study design
states that this will be a randomized, two-armed study with a control group receiving a
placebo and the treatment group receiving Buckeyecillin. Only the investigators will know
,who is receiving which medication. This study is:
a.) A double-blind interventional study
b.) a double-blind observational study
c.) A single-blind observational study
d.) A single-blind interventional study
It assures the identity, strength, quality, and purity of drug products
Why is it important to have good manufacturing practice?
a.) It assures the identity, strength, quality, and purity of drug products
b.) It creates legislation that provides data privacy and security provisions for safeguarding
medical information.
c.) It provides guidelines for the proper care of a patient by their primary care physician.
d.) It's a standard for the design, performance, monitoring, recording, analysis and reporting
of clinical trials or studies meant to protect the rights of human subjects.
Information on the profit margin of the drug
Which of the following is NOT included in a New Drug Application (NDA)?
a.) Proposed label for the drug
b.) Data from human trials
c.) Information on the profit margin of the drug
d.) Data from animal trials
progression-free survival
, Which of the following would be considered a surrogate endpoint?
a.) progression-free survival
b.) overall cure rate
c.) overall survival
d.) time to remission
A drug's formulation has NO impact on which organs the drug can reach in the body.
Which of the following statements about a drug’s formulation is FALSE?
a.) A drug’s formulation has NO impact on which organs the drug can reach in the body.
b.) The formulation determines how long a drug will last.
c.) A drug’s formulation determines how fast the drug will work.
d.) A drug’s formulation is also known as the drug’s dosage form.
It can take up to 5 years to get a new molecule approved by the FDA
Which of the following statements is FALSE regarding the experimentation, or testing, of
unapproved drug products?
a.) It can take up to 5 years to get a new molecule approved by the FDA
b.) Clinical studies utilize animal testing before beginning clinical studies on humans.
c.) About a quarter of pharmaceutical spending is spent on clinical studies
d.) Sometimes the unapproved drug, in rare cases, can be given to severely ill patients when
no other treatment exists.
A collection of information on drug molecules that include their structure, purity,
quantity and physiochemical characteristics
Correct Answers
9 years market exclusivity instead of 5 years
Which of the following is NOT an incentive of the orphan drug designation?
a.) 9 years market exclusivity instead of 5 years
b.) The possibility of the drug company receiving new grants
c.) Tax credits to the drug company
A biologic is not a type of drug according to the FDA definition of a drug
A biologic can be a range of product types. The following is FALSE regarding biologic?
a.) One example of a biologic active ingredient is a vaccine
b.) A biologic is not a type of drug according to the FDA definition of a drug
c.) Biologics include proteins, which may be derived from living systems
d.) Biologics differ from small molecule drugs such as aspirin in both size and complexity
The drug must first be approved as an Investigational New Drug (IND)
Prescription drugs need to first undergo experimentation in preclinical and clinical studies.
Before a drug can enter clinical studies:
a.) The pharmaceutical company must submit a New Drug Application (NDA)
b.) The drug’s active ingredient must be approved by the FDA as a new chemical entity
(NCE)
c.) The drug must first be approved as an Investigational New Drug (IND)
,d.) The drug must show efficacy in humans
Absorption, Distribution, Metabolism and Excretion
What are the 4 parameters that predict the pharmacological profile of a drug?
a.) Absorption, Distribution, Metabolism and Excretion
b.) Adherence, Dispersal, Medication and Elimination
c.) Absorption, Dispersal, Management and Elimination
d.) Application, Distribution, Management and Expulsion
A trial that enrolls patients with the same cancer, but different genetic mutations to
look for potential treatments
What is an umbrella study?
a.) A trial that enrolls patients with multiple cancer types, but a similar genetic mutation to
look for potential treatments
b.) A trial that enrolls patients with the same cancer, but different genetic mutations to look
for potential treatments
c.) A trial that enrolls patients who do not currently have a disease, but are at risk of
developing the disease to study early intervention
d.) A trial in which a group of subjects are followed for long periods of time to watch for a
specific outcome, such as development of a disease
A single-blind interventional study
A phase 3 clinical trial has just begun for the new drug, Buckeyecillin. The study design
states that this will be a randomized, two-armed study with a control group receiving a
placebo and the treatment group receiving Buckeyecillin. Only the investigators will know
,who is receiving which medication. This study is:
a.) A double-blind interventional study
b.) a double-blind observational study
c.) A single-blind observational study
d.) A single-blind interventional study
It assures the identity, strength, quality, and purity of drug products
Why is it important to have good manufacturing practice?
a.) It assures the identity, strength, quality, and purity of drug products
b.) It creates legislation that provides data privacy and security provisions for safeguarding
medical information.
c.) It provides guidelines for the proper care of a patient by their primary care physician.
d.) It's a standard for the design, performance, monitoring, recording, analysis and reporting
of clinical trials or studies meant to protect the rights of human subjects.
Information on the profit margin of the drug
Which of the following is NOT included in a New Drug Application (NDA)?
a.) Proposed label for the drug
b.) Data from human trials
c.) Information on the profit margin of the drug
d.) Data from animal trials
progression-free survival
, Which of the following would be considered a surrogate endpoint?
a.) progression-free survival
b.) overall cure rate
c.) overall survival
d.) time to remission
A drug's formulation has NO impact on which organs the drug can reach in the body.
Which of the following statements about a drug’s formulation is FALSE?
a.) A drug’s formulation has NO impact on which organs the drug can reach in the body.
b.) The formulation determines how long a drug will last.
c.) A drug’s formulation determines how fast the drug will work.
d.) A drug’s formulation is also known as the drug’s dosage form.
It can take up to 5 years to get a new molecule approved by the FDA
Which of the following statements is FALSE regarding the experimentation, or testing, of
unapproved drug products?
a.) It can take up to 5 years to get a new molecule approved by the FDA
b.) Clinical studies utilize animal testing before beginning clinical studies on humans.
c.) About a quarter of pharmaceutical spending is spent on clinical studies
d.) Sometimes the unapproved drug, in rare cases, can be given to severely ill patients when
no other treatment exists.
A collection of information on drug molecules that include their structure, purity,
quantity and physiochemical characteristics
