Quiz 6 Drug Devt I Sp25 Flashcards
What is not true of biologics?
Biologics are not normally susceptible to microbial contamination
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 label
Drug product refers to a finished dosage form. What is not considered a dosage form? Can search for dosage forms at https://www.fda.gov/industry/structured-product-labeling-resources/dosage-forms.
A.) Injectables
B.) Cream
C.) Active ingredient***
D.) Capsules
E.) Elixir
F.) Chewable tablet
What is not true of the inactive ingredients found in drug products?
A.) Inactive ingredients are a common component of drug products
B.) Inactive ingredients do not affect the efficacy properties of a drug product***
C.) Inactive ingredient is not the main drug component that is responsible for pharmacologic activity of a drug product
D.) Inactive ingredients include artificial colorants or preservatives
E.) Inactive ingredients include starch binders in tablets
___________________ 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).
A.) Strength***
B.) Therapeutic activity
C.) Inactive ingredient
D.) Component
E.) Formulation
For drug delivery routes, certain types of APIs enter the body subcutaneously through the skin, while some goes through the tongue in which type of drug delivery?
A.) Intravenous
B.) Intrathecal
C.) Oral
D.) Opthalmic
E.) Nasal
F.) Sublingual*****
What is true of biosimilars?
A.) Clinical trials, with children as subjects, are required for marketing approval of biosimilars
B.) Animal and human clinical studies on safety and efficacy are still required of biosimilars
C.) Biosimilars are significantly superior to the branded product in terms of safety and efficacy
D.) An example of biosimilars would be store brand aspirin or ibuprofen
E.) Biosimilars are generally sold at much higher prices than branded biologics
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?
A.) Tax incentives are given to the manufacturer
B.) Subsidies for clinical research studies are provided by the FDA
C.) FDA waives PDUFA fee requirement
D.) FDA requires smaller patient numbers for clinical testing of the drug
E.) No other version of the drug will be approved during a twelve year market exclusivity
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?
A.) Vaccines, like those for SARS-2
B.) Antibodies, like those against SARS-2
C.) Growth factors
D.) Immunomodulators
E.) Ivermectin, like that for horses
F.) Interferons
Which drug development department may be responsible for developing tests to quantify the ability of an antibody drug to bind to SARS-2 virus?
A.) Regulatory group
B.) Clinical development group
C.) Process development group
D.) Business development group
E.) Assay development group
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:
A.) Prescription
B.) Component
C.) Abuse
D.) Active pharmaceutical ingredient
E.) Indication***
Many biologics are manufactured using living cells. What is not a main concern of the process development group of a biologics manufacturer?
A.) Developing clinical study protocols***
B.) Improving the purification process to optimize yield of the final formulated product
C.) Optimizing product yield of the host cells in the bioreactor
D.) Monitoring the genetic stability or instability of the host cells
E.) If possible, to use E. coli as production host instead of mammalian cells
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?
A.) A new cancer drug that does not cause nausea will be preferred over an existing one that does
B.) Two tablets that separately contain two different APIs will be preferred over one tablet that contains both APIs
C.) For any given drug, more than 50% of patients with a condition may not respond to the existing drug
D.) The currently marketed drug is very expensive
E.) The new drug may be more effective than the currently administered drug against a newly discovered variant of a virus
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:
A.) Consolidated manufacturing organization
B.) Commercialization management organization
C.) Contract manufacturing organization***
D.) Contract management organization
E.) Chinese mandarin oranges
From the Roche video, what is the last step in the drug development process?
A.) Providing regulatory agencies with documentation to support marketing approval***
B.) Test safety and tolerability of candidate drug in human clinical studies
C.) Generate tests and refine lead to come up with optimized chemical
D.) Conduct pre-clinical safety studies using cell cultures or animals
E.) Looking for a starting or lead compound that will act on target
