BTEC 3317 Final UPDATED ACTUAL
Exam Questions and CORRECT Answers
Based on FDA's definition of a drug, what is a drug not supposed to do to a patient's disease
or condition?
Treat
Prevent
Exacerbate
Diagnose
Mitigate - CORRECT ANSWER✔✔- Exacerbate
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 new drug for headache is a combination tablet that contains two different APIs while
currently, two tablets have to be taken separately to get headache relief
The currently marketed drug is very expensive
The currently marketed drug is injectable while the new drug will be oral
An anti-depression drug that produces suicidal thoughts will be preferred over an already
marketed one that doesn't
For any given drug, more than 50% of patients with a condition may not respond to the
existing drug - CORRECT ANSWER✔✔- An anti-depression drug that produces suicidal
thoughts will be preferred over an already marketed one that doesn't
FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or
treatment of disease. What would be an example of a combination drug product?
Pregnancy test kit
Dental floss
Tongue depressor
Baby aspirin
Lab microwave - CORRECT ANSWER✔✔- Pregnancy test kit
,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?
Clinical trial requirement is waived
PDUFA fees are waived
Smaller patient numbers are required for clinical trials
No other version of the drug will be approved during a seven year market exclusivity
Tax incentives are given to the manufacturer - CORRECT ANSWER✔✔- Clinical trial
requirement is waived
What is not true of biosimilars?
Cardiotoxicity studies may not be required of a biosimilar if branded drug has no known
cardiotoxicity issues
Cardiotoxicity studies are required for approval of biosimilars
Animal and human clinical studies on safety and efficacy are still required of biosimilars
Biosimilars are generally sold at much lower prices than branded biologics
Biosimilars are not meaningfully different from the branded product in terms of safety and
efficacy - CORRECT ANSWER✔✔- Cardiotoxicity studies are required for approval of
biosimilars
Many biotech companies do not have the capacity to do all drug manufacturing activities on
their own and have to rely on CMOs. CMO stands for:
Chinese mandarin oranges
Contract manufacturing organization
Consolidated manufacturing organization
Contract management organization
Commercialization management organization - CORRECT ANSWER✔✔- Contract
manufacturing organization
,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:
Abuse
Component
Prescription
Indication
Active pharmaceutical ingredient - CORRECT ANSWER✔✔- indication
Many biologics are manufactured using living cells. What is not a main concern of the
process development group of a biologics manufacturer?
Optimizing product yield of the host cells in the bioreactor
Improving the ease of growing the production cells
Optimizing yield of formulated product through improved purification process
File the drug marketing application with the FDA
Minimize the possible loss of the recombinant DNA in the production cells - CORRECT
ANSWER✔✔- File the marketing application with the FDA
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?
Same container and closure
Same active ingredient
Same dosage form
Same route of administration
Safe to patients
Same strength - CORRECT ANSWER✔✔- Same container and closure
Drug product refers to a finished dosage form. What is not considered a dosage form?
, Syrups
Injectables
Elixir
Cream
Capsules
Artificial sweetener - CORRECT ANSWER✔✔- Artificial sweetener
What is not true of the inactive ingredients found in drug products?
Inactive ingredients are considered drug contaminants
Inactive ingredients include starch binders in tablets
Inactive ingredients are a common component of drug products
Inactive ingredients include artificial colorants or preservatives
Inactive ingredients can affect the safety and efficacy properties of a drug product -
CORRECT ANSWER✔✔- Inactive ingredients are considered drug contaminants
Prior to release for marketing, one critical quality attribute of any drug product that needs to
be met is strength. What is not a unit of strength?
Number of tablets per container
Weight of the API per capsule
Weight of the API per tablet
Amount of API per unit volume
International units or IU - CORRECT ANSWER✔✔- Number of tablets per container
From the Roche video, what is the first step in the drug development process?
Finding an overactive protein in cancers that a drug could potentially target
Test safety and tolerability of candidate drug in human clinical studies
Obtaining regulatory approval and marketing launch
Conduct pre-clinical safety studies using cell cultures or animals
Exam Questions and CORRECT Answers
Based on FDA's definition of a drug, what is a drug not supposed to do to a patient's disease
or condition?
Treat
Prevent
Exacerbate
Diagnose
Mitigate - CORRECT ANSWER✔✔- Exacerbate
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 new drug for headache is a combination tablet that contains two different APIs while
currently, two tablets have to be taken separately to get headache relief
The currently marketed drug is very expensive
The currently marketed drug is injectable while the new drug will be oral
An anti-depression drug that produces suicidal thoughts will be preferred over an already
marketed one that doesn't
For any given drug, more than 50% of patients with a condition may not respond to the
existing drug - CORRECT ANSWER✔✔- An anti-depression drug that produces suicidal
thoughts will be preferred over an already marketed one that doesn't
FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or
treatment of disease. What would be an example of a combination drug product?
Pregnancy test kit
Dental floss
Tongue depressor
Baby aspirin
Lab microwave - CORRECT ANSWER✔✔- Pregnancy test kit
,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?
Clinical trial requirement is waived
PDUFA fees are waived
Smaller patient numbers are required for clinical trials
No other version of the drug will be approved during a seven year market exclusivity
Tax incentives are given to the manufacturer - CORRECT ANSWER✔✔- Clinical trial
requirement is waived
What is not true of biosimilars?
Cardiotoxicity studies may not be required of a biosimilar if branded drug has no known
cardiotoxicity issues
Cardiotoxicity studies are required for approval of biosimilars
Animal and human clinical studies on safety and efficacy are still required of biosimilars
Biosimilars are generally sold at much lower prices than branded biologics
Biosimilars are not meaningfully different from the branded product in terms of safety and
efficacy - CORRECT ANSWER✔✔- Cardiotoxicity studies are required for approval of
biosimilars
Many biotech companies do not have the capacity to do all drug manufacturing activities on
their own and have to rely on CMOs. CMO stands for:
Chinese mandarin oranges
Contract manufacturing organization
Consolidated manufacturing organization
Contract management organization
Commercialization management organization - CORRECT ANSWER✔✔- Contract
manufacturing organization
,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:
Abuse
Component
Prescription
Indication
Active pharmaceutical ingredient - CORRECT ANSWER✔✔- indication
Many biologics are manufactured using living cells. What is not a main concern of the
process development group of a biologics manufacturer?
Optimizing product yield of the host cells in the bioreactor
Improving the ease of growing the production cells
Optimizing yield of formulated product through improved purification process
File the drug marketing application with the FDA
Minimize the possible loss of the recombinant DNA in the production cells - CORRECT
ANSWER✔✔- File the marketing application with the FDA
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?
Same container and closure
Same active ingredient
Same dosage form
Same route of administration
Safe to patients
Same strength - CORRECT ANSWER✔✔- Same container and closure
Drug product refers to a finished dosage form. What is not considered a dosage form?
, Syrups
Injectables
Elixir
Cream
Capsules
Artificial sweetener - CORRECT ANSWER✔✔- Artificial sweetener
What is not true of the inactive ingredients found in drug products?
Inactive ingredients are considered drug contaminants
Inactive ingredients include starch binders in tablets
Inactive ingredients are a common component of drug products
Inactive ingredients include artificial colorants or preservatives
Inactive ingredients can affect the safety and efficacy properties of a drug product -
CORRECT ANSWER✔✔- Inactive ingredients are considered drug contaminants
Prior to release for marketing, one critical quality attribute of any drug product that needs to
be met is strength. What is not a unit of strength?
Number of tablets per container
Weight of the API per capsule
Weight of the API per tablet
Amount of API per unit volume
International units or IU - CORRECT ANSWER✔✔- Number of tablets per container
From the Roche video, what is the first step in the drug development process?
Finding an overactive protein in cancers that a drug could potentially target
Test safety and tolerability of candidate drug in human clinical studies
Obtaining regulatory approval and marketing launch
Conduct pre-clinical safety studies using cell cultures or animals
