BTEC regulatory environment quiz 6

Here are the flashcards with all possible answer choices included in the term section:

1. What is not true of biologics?

   • A) Biologics include any natural protein consisting of more than 40 amino acids

   • B) Chemical characterization of a biologics is not easily accomplished using analytical chemistry techniques

   • C) Biologics can be made up of more than 10,000 atoms

   • D) Biologics are not normally susceptible to microbial contamination

   • E) Biologics are derived mostly from living organisms

   • Answer: D) Biologics are not normally susceptible to microbial contamination.

2. 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?

   • A) Same strength

   • B) Same dosage form

   • C) Same label

   • D) Same active ingredient

   • E) Same route of administration

   • Answer: C) Same label.

3. What is not considered a dosage form?

   • A) Cream

   • B) Capsules

   • C) Injectables

   • D) Active ingredient

   • E) Chewable tablet

   • Answer: D) Active ingredient.

4. What is not true of the inactive ingredients found in drug products?

   • A) Inactive ingredients include starch binders in tablets

   • B) Inactive ingredients include artificial colorants or preservatives

   • C) Inactive ingredient is not the main drug component that is responsible for pharmacologic activity of a drug product

   • D) Inactive ingredients are a common component of drug products

   • E) Inactive ingredients do not affect the efficacy properties of a drug product

   • Answer: E) Inactive ingredients do not affect the efficacy properties of a drug product.

5. _______ 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) Formulation

   • B) Strength

   • C) Therapeutic activity

   • D) Component

   • E) Inactive ingredient

   • Answer: B) Strength.

6. 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) Intrathecal

   • B) Nasal

   • C) Intravenous

   • D) Ophthalmic

   • E) Sublingual

   • Answer: E) Sublingual.

7. What is true of biosimilars?

   • A) Biosimilars are significantly superior to the branded product in terms of safety and efficacy

   • B) An example of biosimilars would be store brand aspirin or ibuprofen

   • C) Clinical trials, with children as subjects, are required for marketing approval of biosimilars

   • D) Animal and human clinical studies on safety and efficacy are still required of biosimilars

   • E) Biosimilars are generally sold at much higher prices than branded biologics

   • Answer: D) Animal and human clinical studies on safety and efficacy are still required of biosimilars.

8. What is not an incentive given to manufacturers to encourage the development of orphan drugs?

   • A) Tax incentives are given to the manufacturer

   • B) FDA requires smaller patient numbers for clinical testing of the drug

   • C) FDA waives PDUFA fee requirement

   • D) No other version of the drug will be approved during a twelve year market exclusivity

   • E) Subsidies for clinical research studies are provided by the FDA

   • Answer: D) No other version of the drug will be approved during a twelve year market exclusivity.

9. Which of these products are reviewed and regulated by CBER?

   • A) Immunomodulators

   • B) Growth factors

   • C) Ivermectin, like that for horses

   • D) Antibodies, like those against SARS-2

   • E) Vaccines, like those for SARS-2

   • Answer: E) Vaccines, like those for SARS-2.

10. 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) Process development group

    • B) Regulatory group

    • C) Clinical development group

    • D) Assay development group

    • E) Business development group

    • Answer: D) Assay development group.

11. In drug regulation, the use of a drug for a particular disease or condition is referred to as its:

    • A) Indication

    • B) Abuse

    • C) Component

    • D) Prescription

    • E) Active pharmaceutical ingredient

    • Answer: A) Indication.

12. What is not a main concern of the process development group of a biologics manufacturer?

    • A) Developing clinical study protocols

    • B) Monitoring the genetic stability or instability of the host cells

    • C) Optimizing product yield of the host cells in the bioreactor

    • D) Improving the purification process to optimize yield of the final formulated product

    • E) If possible, to use E. coli as production host instead of mammalian cells

    • Answer: A) Developing clinical study protocols.

13. 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) Two tablets that separately contain two different APIs will be preferred over one tablet that contains both APIs

    • B) The currently marketed drug is very expensive

    • C) For any given drug, more than 50% of patients with a condition may not respond to the existing drug

    • D) A new cancer drug that does not cause nausea will be preferred over an existing one that does

    • E) The new drug may be more effective than the currently administered drug against a newly discovered variant of a virus

    • Answer: A) Two tablets that separately contain two different APIs will be preferred over one tablet that contains both APIs.

14. CMO stands for:

    • A) Chinese mandarin oranges

    • B) Contract management organization

    • C) Contract manufacturing organization

    • D) Commercialization management organization

    • E) Consolidated manufacturing organization

    • Answer: C) Contract manufacturing organization.

15. 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) Generate tests and refine lead to come up with optimized chemical

    • C) Conduct pre-clinical safety studies using cell cultures or animals

    • D) Test safety and tolerability of candidate drug in human clinical studies

    • E) Looking for a starting or lead compound that will act on target

    • Answer: A) Providing regulatory agencies with documentation to support marketing approval.