BTEC 3317 Exam Questions with Verified Solutions Latest Version 2024-2025
"Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000
patients in the US. What is not an incentive given to manufacturers to encourage the development of
orphan drugs?" - Answers No other version of the drug will be approved during a twelve year market
exclusivity
What is not true of the inactive ingredients found in drug products? - Answers Inactive ingredients do
not affect the efficacy properties of a drug product
"FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of
disease. In drug regulation, the use of a drug for a particular disease or condition is referred to as its:" -
Answers Indication
"The FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from industry to
fund and speed up reviews of different types of drugs. In the Generic and Biosimilars UFA, the final user
fees are what percent of the typical user fees for a branded drug PDUFA?" - Answers 10%
"___________________ of a drug product is expressed as concentration of API (wt per vol, wt per wt, wt
per tablet) or in activity units (IU or international units). " - Answers Strength
Generic drugs have certain properties that should be the same as brand name drugs. What is not
expected to be the same in a generic and in a branded drug? - Answers Same label
Many biologics are manufactured using living cells. What is not a main concern of the process
development group of a biologics manufacturer? - Answers Developing the budget for clinical studies
What is true of biosimilars? - Answers Animal and human clinical studies on safety and efficacy are still
required of biosimilars
"From the Roche video, what is the first step in the drug development process?" - Answers Identifying a
molecular target for a candidate drug
What is not true of biologics? - Answers Biologics are not normally susceptible to microbial
contamination
Which department in a drug development company is responsible of filing patents with the US Patent
and Trademark office to protect the company's intellectual property or inventions? - Answers Legal
group
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? - Answers A new drug that has to be taken once a week for
life is preferred over one that will need to be administered just twice in a lifetime
"For drug delivery routes, certain types of APIs enter the body subcutaneously through the skin, while
some goes through the tongue in which type of drug delivery?" - Answers Sublingual
, The FDA office that regulates pharmaceutical and some biologic drugs including antibodies and growth
factors is the: - Answers Center for Drug Evaluation and Research
Drug product refers to a finished dosage form. What is not considered a dosage form? - Answers Active
ingredient
What is not correct about the regulation of animal research under the Animal Welfare Act of 1966? -
Answers -The Animal Welfare Act requires the use of animals in all tests of candidate human drugs
The main goal of pre-clinical animal testing is to determine the ______________starting dose to use in
initial clinical trials for therapeutics in healthy human volunteers. - Answers Maximum safe starting dose
The OECD published a series of principles of Good Laboratory Practices and Compliance Monitoring.
What does not apply to the OECD and the GLP principles? - Answers The shared GLP principles are in
place to impose trade barriers for tested chemicals among member countries
Which is not true of Good Laboratory Practices? - Answers Started with deaths of test animals due to
excessive bleeding from warfarin
"According to the Roche video on target identification, there are at least 3 approaches to finding a
candidate drug target. What is not one of the three?" - Answers Identifying what enzyme is involved in
changing a drug to a less active chemmical derivative
FDA approval is not required prior to conducting pre-clinical animal research even if the candidate drug
will be submitted later to the FDA for marketing approval. - Answers TRUE
"Roche video. To achieve it's therapeutic effects, all drugs interact with their protein targets and inhibit
the proteins' functions." - Answers FALSE
"During pre-clinical research, a starting lead compound usually requires optimization of one or more of
its properties. What is not a property of a lead compound that researchers attempt to optimize?" -
Answers Increasing patient dependence on the drug
"As part of in vivo research, the Ames test is performed using bacteria to determine which property of a
candidate drug?" - Answers The ability of a drug to produce DNA lesions
What is not compliant with GLP requirements regarding facilities or operation of facilities used for
animal testing? - Answers Animals of different species should co-mingle in the same room
One type of pre-clinical research experiment is in vitro research involving mechanism of action (MOA)
studies. What does mechanism of action pertain to?
-cellular movement in response to a chemical
-the manner in which skeletal muscle contracts
"Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000
patients in the US. What is not an incentive given to manufacturers to encourage the development of
orphan drugs?" - Answers No other version of the drug will be approved during a twelve year market
exclusivity
What is not true of the inactive ingredients found in drug products? - Answers Inactive ingredients do
not affect the efficacy properties of a drug product
"FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of
disease. In drug regulation, the use of a drug for a particular disease or condition is referred to as its:" -
Answers Indication
"The FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from industry to
fund and speed up reviews of different types of drugs. In the Generic and Biosimilars UFA, the final user
fees are what percent of the typical user fees for a branded drug PDUFA?" - Answers 10%
"___________________ of a drug product is expressed as concentration of API (wt per vol, wt per wt, wt
per tablet) or in activity units (IU or international units). " - Answers Strength
Generic drugs have certain properties that should be the same as brand name drugs. What is not
expected to be the same in a generic and in a branded drug? - Answers Same label
Many biologics are manufactured using living cells. What is not a main concern of the process
development group of a biologics manufacturer? - Answers Developing the budget for clinical studies
What is true of biosimilars? - Answers Animal and human clinical studies on safety and efficacy are still
required of biosimilars
"From the Roche video, what is the first step in the drug development process?" - Answers Identifying a
molecular target for a candidate drug
What is not true of biologics? - Answers Biologics are not normally susceptible to microbial
contamination
Which department in a drug development company is responsible of filing patents with the US Patent
and Trademark office to protect the company's intellectual property or inventions? - Answers Legal
group
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? - Answers A new drug that has to be taken once a week for
life is preferred over one that will need to be administered just twice in a lifetime
"For drug delivery routes, certain types of APIs enter the body subcutaneously through the skin, while
some goes through the tongue in which type of drug delivery?" - Answers Sublingual
, The FDA office that regulates pharmaceutical and some biologic drugs including antibodies and growth
factors is the: - Answers Center for Drug Evaluation and Research
Drug product refers to a finished dosage form. What is not considered a dosage form? - Answers Active
ingredient
What is not correct about the regulation of animal research under the Animal Welfare Act of 1966? -
Answers -The Animal Welfare Act requires the use of animals in all tests of candidate human drugs
The main goal of pre-clinical animal testing is to determine the ______________starting dose to use in
initial clinical trials for therapeutics in healthy human volunteers. - Answers Maximum safe starting dose
The OECD published a series of principles of Good Laboratory Practices and Compliance Monitoring.
What does not apply to the OECD and the GLP principles? - Answers The shared GLP principles are in
place to impose trade barriers for tested chemicals among member countries
Which is not true of Good Laboratory Practices? - Answers Started with deaths of test animals due to
excessive bleeding from warfarin
"According to the Roche video on target identification, there are at least 3 approaches to finding a
candidate drug target. What is not one of the three?" - Answers Identifying what enzyme is involved in
changing a drug to a less active chemmical derivative
FDA approval is not required prior to conducting pre-clinical animal research even if the candidate drug
will be submitted later to the FDA for marketing approval. - Answers TRUE
"Roche video. To achieve it's therapeutic effects, all drugs interact with their protein targets and inhibit
the proteins' functions." - Answers FALSE
"During pre-clinical research, a starting lead compound usually requires optimization of one or more of
its properties. What is not a property of a lead compound that researchers attempt to optimize?" -
Answers Increasing patient dependence on the drug
"As part of in vivo research, the Ames test is performed using bacteria to determine which property of a
candidate drug?" - Answers The ability of a drug to produce DNA lesions
What is not compliant with GLP requirements regarding facilities or operation of facilities used for
animal testing? - Answers Animals of different species should co-mingle in the same room
One type of pre-clinical research experiment is in vitro research involving mechanism of action (MOA)
studies. What does mechanism of action pertain to?
-cellular movement in response to a chemical
-the manner in which skeletal muscle contracts
