BTEC 3317 Quiz 6

What is not true of biologics?

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

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

Biologics are not normally susceptible to microbial contamination

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

Biologics are not normally susceptible to microbial contamination

3 multiple choice options

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 dosage form

Same route of administration

Same label

Same active ingredient

Same label

3 multiple choice options

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.

Capsules

Active ingredient

Injectables

Elixir

Active ingredient

3 multiple choice options

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

Inactive ingredients are a common component of drug products

Inactive ingredients include starch binders in tablets

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

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

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

3 multiple choice options

___________________ 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).

Formulation

Strength

Inactive ingredient

Therapeutic activity

Strength

3 multiple choice options

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?

Intrathecal

Oral

Sublingual

Intravenous

Sublingual

3 multiple choice options

What is true of biosimilars?

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

An example of biosimilars would be store brand aspirin or ibuprofen

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

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

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

3 multiple choice options

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?

FDA waives PDUFA fee requirement

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

Subsidies for clinical research studies are provided by the FDA

FDA requires smaller patient numbers for clinical testing of the drug

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

3 multiple choice options

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?

Antibodies, like those against SARS-2

Growth factors

Immunomodulators

Vaccines, like those for SARS-2

Vaccines, like those for SARS-2

3 multiple choice options

Which drug development department may be responsible for developing tests to quantify the ability of an antibody drug to bind to SARS-2 virus?

Business development group

Assay development group

Process development group

Clinical development group

Assay development group

3 multiple choice options

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:

Active pharmaceutical ingredient

Prescription

Indication

Component

Indication

3 multiple choice options

Many biologics are manufactured using living cells. What is not a main concern of the process development group of a biologics manufacturer?

Developing clinical study protocols

Improving the purification process to optimize yield of the final formulated product

Monitoring the genetic stability or instability of the host cells

Optimizing product yield of the host cells in the bioreactor

Developing clinical study protocols

3 multiple choice options

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 new cancer drug that does not cause nausea will be preferred over an existing one that does

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

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

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

3 multiple choice options

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:

Commercialization management organization

Contract manufacturing organization

Consolidated manufacturing organization

Contract management organization

Contract manufacturing organization

3 multiple choice options

From the Roche video, what is the last step in the drug development process?

Generate tests and refine lead to come up with optimized chemical

Providing regulatory agencies with documentation to support marketing approval

Test safety and tolerability of candidate drug in human clinical studies

Conduct pre-clinical safety studies using cell cultures or animals

Providing regulatory agencies with documentation to support marketing approval

3 multiple choice options