BTECH TEST 2 QUESTIONS AND ANSWERS
FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from
industry to fund/speed up reviews of different types of drugs. In the Generic &
Biosimilars UFA, the final user fees are what percent of the typical user fees for a
branded drug PDUFA?
90%
10%
50%
30%
20% - Answers - 10%
_________of a drug product is expressed as concentration (wt per vol, wt per wt, wt per
tablet) or in activity units (IU or international units). "
Strength
Formulation
Component
Therapeutic activity
Inactive ingredient - Answers - Strength
What is true of biosimilars?
Same active ingredient
Same label design
Same route of administration
Same dosage form
Same strength - Answers - Same label design
What is not true of inactive ingredients?
,Inactive ingredient is not the main drug component that is responsible for pharmacologic
activity of a drug product
Inactive ingredients include starch binders in tablets
Inactive ingredients are a common component of drug products
Inactive ingredients do not affect the safety properties of a drug product
Inactive ingredients include artificial colorants or preservatives - Answers - Inactive
ingredients do not affect the safety properties of a drug product
"Which group in a drug development company performs comparability studies, or tests
of product attributes from one manufacturing batch to another?"
Research group
Business development
Process development group
Legal
Quality control group - Answers - Quality control group
"In drug regulation, the use of a drug for a particular disease or condition is referred to
as its:"
Indication
Abuse
Component
Active pharmaceutical ingredient
Providence - Answers - Indication
"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?"
Tax incentives are given to the manufacturer
, PDUFA fees are waived
Smaller patient numbers are required for clinical trials
No other version of the drug will be approved during a three year market exclusivity
Clinical research subsidies are provided - Answers - No other version of the drug will be
approved during a three year market exclusivity
"Component refers to any ingredient used in the manufacture of a drug product,
including those that may not appear in the marketed drug product, while the active
ingredient is the drug product component that furnishes pharmacological activity or
other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease,
or to affect the structure or any function of the body of man. Which of the following is an
active ingredient?"
Colorant
Artificial sweetener
Preservative
Ibuprofen
Starch binder - Answers - Ibuprofen
What is not true of biologics?
Susceptible to microbial contamination thus requiring aseptic or sterile handling
techniques
Chemical characterization of a biologic is easily accomplished using analytical
chemistry techniques
Biologics are generally heat sensitive
Biologics include insulin which is made up of 51 amino acids
"Biologics include antibodies, vaccines, stem cells, and blood products" - Answers -
Chemical characterization of a biologic is easily accomplished using analytical
chemistry techniques
Drug product refers to a finished dosage form. What is not considered a dosage form?
Tablets
Active ingredient
FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from
industry to fund/speed up reviews of different types of drugs. In the Generic &
Biosimilars UFA, the final user fees are what percent of the typical user fees for a
branded drug PDUFA?
90%
10%
50%
30%
20% - Answers - 10%
_________of a drug product is expressed as concentration (wt per vol, wt per wt, wt per
tablet) or in activity units (IU or international units). "
Strength
Formulation
Component
Therapeutic activity
Inactive ingredient - Answers - Strength
What is true of biosimilars?
Same active ingredient
Same label design
Same route of administration
Same dosage form
Same strength - Answers - Same label design
What is not true of inactive ingredients?
,Inactive ingredient is not the main drug component that is responsible for pharmacologic
activity of a drug product
Inactive ingredients include starch binders in tablets
Inactive ingredients are a common component of drug products
Inactive ingredients do not affect the safety properties of a drug product
Inactive ingredients include artificial colorants or preservatives - Answers - Inactive
ingredients do not affect the safety properties of a drug product
"Which group in a drug development company performs comparability studies, or tests
of product attributes from one manufacturing batch to another?"
Research group
Business development
Process development group
Legal
Quality control group - Answers - Quality control group
"In drug regulation, the use of a drug for a particular disease or condition is referred to
as its:"
Indication
Abuse
Component
Active pharmaceutical ingredient
Providence - Answers - Indication
"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?"
Tax incentives are given to the manufacturer
, PDUFA fees are waived
Smaller patient numbers are required for clinical trials
No other version of the drug will be approved during a three year market exclusivity
Clinical research subsidies are provided - Answers - No other version of the drug will be
approved during a three year market exclusivity
"Component refers to any ingredient used in the manufacture of a drug product,
including those that may not appear in the marketed drug product, while the active
ingredient is the drug product component that furnishes pharmacological activity or
other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease,
or to affect the structure or any function of the body of man. Which of the following is an
active ingredient?"
Colorant
Artificial sweetener
Preservative
Ibuprofen
Starch binder - Answers - Ibuprofen
What is not true of biologics?
Susceptible to microbial contamination thus requiring aseptic or sterile handling
techniques
Chemical characterization of a biologic is easily accomplished using analytical
chemistry techniques
Biologics are generally heat sensitive
Biologics include insulin which is made up of 51 amino acids
"Biologics include antibodies, vaccines, stem cells, and blood products" - Answers -
Chemical characterization of a biologic is easily accomplished using analytical
chemistry techniques
Drug product refers to a finished dosage form. What is not considered a dosage form?
Tablets
Active ingredient
