BTECH PREP TEST 2 QUESTIONS & ANSWERS 2024/2025
"From the Roche video, what is the last step in the drug development process?" - ANSWERSProviding regulatory agencies with documentation to support marketing approval
Generic drugs have certain properties that should be the same as brand name ...
"From the Roche video, what is the last step in the drug development process?" - ANSWERSProviding
regulatory agencies with documentation to support marketing approval
Generic drugs have certain properties that should be the same as brand name drugs. What is expected
to be the same in a generic and in a branded drug? - ANSWERSSame indication
Same route of administration
Same active ingredient
Same dosage form
What is true of the inactive ingredients found in drug products? - ANSWERS-Inactive ingredients include
artificial colorants or preservatives
-Inactive ingredients can affect the safety and efficacy properties of a drug product
-Inactive ingredients are drug product components that include the cherry flavor in certain cough
medicines
-Inactive ingredients are also commonly referred to as excipients
"Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000
patients in the US. What is an incentive given to manufacturers to encourage the development of orphan
drugs?" - ANSWERS-No other version of the drug will be approved during a seven year market exclusivity
-PDUFA fees are waived
-Tax incentives are given to the manufacturer
-Clinical trial subsidies are provided by the US government
"Johnson and Johnson picked Emergent Biosciences as CMO to manufacture the COVID vaccine for JNJ
because JNJ didn't have spare facility, equipment, and personnel for large scale production of their
vaccine. CMO stands for:" - ANSWERSContract manufacturing organization
, Indication - ANSWERS"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:"
"FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of
disease. What would be examples of a combination drug product?" - ANSWERS-Asthma inhalers
-Insulin pumps
-Estrogen patches
-Pregnancy test kit
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? - ANSWERS-A new cancer drug that does not cause nausea will
be preferred over an existing one that does
-The currently marketed drug is very expensive
-The new drug may be more effective than the currently administered drug against a newly discovered
variant of a virus
-"For any given drug, more than 50% of patients with a condition may not respond to the existing drug"
Component - ANSWERS"________________ means any ingredient used in the manufacture of a drug
product, including those that may not appear in the marketed drug product."
"The FDA's Center for Biologics Evaluation and Research (CBER) handles marketing approval of many, but
not all biologics. Which of these products are reviewed and regulated by CBER?" - ANSWERS"Vaccines,
like those for SARS-2 "
Strength - ANSWERS"___________________ 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). "
What is true of biologics? - ANSWERS-Chemical characterization of a biologic is not easily accomplished
using analytical chemistry techniques
-Biologics include any natural protein consisting of more than 40 amino acids
-Biologics are derived mostly from living organisms
-"Biologics can be made up of more than 10,000 atoms"
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