BTECH Test 2 Questions & Answers 2024/2025
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...
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% - ANSWERS10%
_________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 - ANSWERSStrength
What is true of biosimilars?
Same active ingredient
Same label design
Same route of administration
Same dosage form
Same strength - ANSWERSSame 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 - ANSWERSInactive ingredients do not
affect the safety properties of a drug product
,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" - ANSWERSChemical
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
Syrups
Sublingual strips
Injectables - ANSWERSActive ingredient
"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 - ANSWERSQuality 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 - ANSWERSIndication
"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
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