BTEC Prep Exam 2 Questions & Answers 2024/2025
In drug regulation, indication refers to: - ANSWERSthe condition that could be treated by an approved drug
What is true of biologics - ANSWERS"Biologics include growth factors, antibodies, and vaccines"
Biologics is any natural or recombinant ...
In drug regulation, indication refers to: - ANSWERSthe condition that could be treated by an approved
drug
What is true of biologics - ANSWERS"Biologics include growth factors, antibodies, and vaccines"
Biologics is any natural or recombinant protein drug less than 40 amino acids long
Biologics are generally stable even when subjected to high temperatures
"Biologics are never made up of more than 10,000 atoms"
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? - ANSWERSEstrogen patches
-
NOT EXAMPLES
Baby aspirin
Lab microwave
PCR used for disease diagnostics
Dental floss
Prior to release for marketing, one critical quality attribute of any drug product that needs to be met is
strength. What is a unit of strength? - ANSWERSWeight of the API per capsule
Amount of API per unit volume
Weight of the API per tablet
International units or IU
Not a unit: Number of tablets per container
,From the Roche video, what is the last step in the drug development process? - ANSWERSProviding
regulatory agencies with documentation to support marketing approval
Which drug development department may be responsible for developing ELISA tests for looking at
biomarker changes in cancer patients? - ANSWERSAssay development group
Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000
patients in the US. What are the incentives given to manufacturers to encourage the development of
orphan drugs? - ANSWERS1. No other version of the drug will be approved during a seven year market
exclusivity
2. Smaller patient numbers are required for clinical trials
3. Clinical research subsidies are provided
4. Tax incentives are given to the manufacturer
NOT
PDUFA fees are reduced by 90%
Many biologics are manufactured using living cells. What is a main concern of the process development
group of a biologics manufacturer? - ANSWERSOptimizing product yield of the host cells in the
bioreactor
Minimize the possible loss of the recombinant DNA in the production cells
Optimizing yield of formulated product through improved purification process
Improving the ease of growing the production cells
What is true of the inactive ingredients found in drug products? - ANSWERS1. include starch binders in
tablets, artificial colorants or preservatives, sweetners
2. can affect the safety and efficacy properties of a drug product
3. a common component of drug products
Drug product refers to a finished dosage form. What is considered a dosage form? - ANSWERSCapsules
Injectables
Chewable tablet
, Ointment
Elixir
ou'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?
what might increase it? - ANSWERSdec: A manufacturer of a marketed drug came up with a new
formulation where the drug has to be taken once a week instead of daily
inc: 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
The ruling party proposed an increased budget for federal spending for health coverage
Patients have stopped responding to a drug that is currently in use
Moderna picked Catalent Pharma Solutions as CMO to manufacture the COVID mRNA vaccine for
Moderna because Moderna didn't have spare facility, equipment, and personnel for large scale
production of their vaccine. CMO stands for:" - ANSWERSContract manufacturing organization
Which of the following is an active ingredient - ANSWERSAspirin
NOT: Artificial sweetener
Starch binder
Preservative
Colorant
What is 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? - ANSWERSA new cancer drug that does not cause nausea will
be preferred over an existing one that does
"For any given drug, more than 50% of patients with a condition may not respond to the existing drug"
The new drug can be for a cancer that had become resistant to a currently administered drug
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