BTEC 3320 EXAM 2 UPDATED TEST PAPER
SOLVED QUESTIONS FULL SOLUTION
●● There's a drug under development that is in a more advance stage of
clinical trials
Answer: You're tasked with doing market analysis for the new drug that
your company is developing. What might decrease the future market
earnings for your new drug?
The drug under development works by a novel mechanism that is
different from the marketed drug
The current widely used drug is being withdrawn from the market due to
toxicity
Patients have stopped responding to a drug that is currently in use
There's a drug under development that is in a more advance stage of
clinical trials
The ruling party proposed an increased budget for federal spending for
health coverage
●● Two tablets that separately contain two different APIs will be
preferred over one tablet that contains both APIs
Answer: What is not a good reason as to why there may remain a market
for a new drug even if there is already an approved drug for a particular
indication?
,The currently marketed drug is very expensive
A new cancer drug that does not cause nausea will be preferred over an
existing one that does
Two tablets that separately contain two different APIs will be preferred
over one tablet that contains both APIs
"For any given drug, more than 50% of patients with a condition may
not respond to the existing drug"
The currently marketed drug is injectable while the new drug will be
oral
●● Assay development group
Answer: Which drug development department may be responsible for
developing PCR procedures to test for the proper integration of a gene
therapy construct in the genome of treated patients?
Clinical development group
Regulatory group
Process development group
Business development group
Assay development group
●● Center for Drug Evaluation and Research
,Answer: The FDA office that regulates pharmaceutical and some
biologic drugs including antibodies and growth factors is the:
Center for Biologics Evaluation and Research
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Food Safety and Applied Nutrition
Center for Device and Radiological Health
●● process validation plan
Answer: "As part of a robust manufacturing plan, to increase assurance
of consistency in product quality from batch to batch of manufactured
drug, part of the manufacturing plan is to have
_____________________ in place. "
process validation plan
risk assessment
team building strategy
industrial advisory board
performance-based yearly bonus
●● Increasing the number of patients who will use the manufactured
drug
, Answer: Many biologics are manufactured using living cells. What is
not a concern of the process development group of a biologics
manufacturer?
Improving the ease of growing the production cells
Increasing the number of patients who will use the manufactured drug
Optimizing yield of formulated product through improved purification
process
Minimize the possible loss of the recombinant DNA in the production
cells
Optimizing product yield of the host cells in the bioreactor
●● Component
Answer: "________________ means any ingredient used in the
manufacture of a drug product, including those that may not appear in
the marketed drug product."
Component
Inactive ingredients
Active pharmaceutical ingredient
Excipient
Dosage form
●● Quality control group
SOLVED QUESTIONS FULL SOLUTION
●● There's a drug under development that is in a more advance stage of
clinical trials
Answer: You're tasked with doing market analysis for the new drug that
your company is developing. What might decrease the future market
earnings for your new drug?
The drug under development works by a novel mechanism that is
different from the marketed drug
The current widely used drug is being withdrawn from the market due to
toxicity
Patients have stopped responding to a drug that is currently in use
There's a drug under development that is in a more advance stage of
clinical trials
The ruling party proposed an increased budget for federal spending for
health coverage
●● Two tablets that separately contain two different APIs will be
preferred over one tablet that contains both APIs
Answer: What is not a good reason as to why there may remain a market
for a new drug even if there is already an approved drug for a particular
indication?
,The currently marketed drug is very expensive
A new cancer drug that does not cause nausea will be preferred over an
existing one that does
Two tablets that separately contain two different APIs will be preferred
over one tablet that contains both APIs
"For any given drug, more than 50% of patients with a condition may
not respond to the existing drug"
The currently marketed drug is injectable while the new drug will be
oral
●● Assay development group
Answer: Which drug development department may be responsible for
developing PCR procedures to test for the proper integration of a gene
therapy construct in the genome of treated patients?
Clinical development group
Regulatory group
Process development group
Business development group
Assay development group
●● Center for Drug Evaluation and Research
,Answer: The FDA office that regulates pharmaceutical and some
biologic drugs including antibodies and growth factors is the:
Center for Biologics Evaluation and Research
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Food Safety and Applied Nutrition
Center for Device and Radiological Health
●● process validation plan
Answer: "As part of a robust manufacturing plan, to increase assurance
of consistency in product quality from batch to batch of manufactured
drug, part of the manufacturing plan is to have
_____________________ in place. "
process validation plan
risk assessment
team building strategy
industrial advisory board
performance-based yearly bonus
●● Increasing the number of patients who will use the manufactured
drug
, Answer: Many biologics are manufactured using living cells. What is
not a concern of the process development group of a biologics
manufacturer?
Improving the ease of growing the production cells
Increasing the number of patients who will use the manufactured drug
Optimizing yield of formulated product through improved purification
process
Minimize the possible loss of the recombinant DNA in the production
cells
Optimizing product yield of the host cells in the bioreactor
●● Component
Answer: "________________ means any ingredient used in the
manufacture of a drug product, including those that may not appear in
the marketed drug product."
Component
Inactive ingredients
Active pharmaceutical ingredient
Excipient
Dosage form
●● Quality control group
