Exam 2: Stages Of Drug Development I Flashcards
What is true of biologics?
A) Biologics include growth factors, antibodies, and vaccines
B) Biologics is any natural or recombinant protein drug less than 40 amino acids long
C) Biologics are never made up of more than 10,000 atoms
D) Biologics are generally stable even when subjected to high temperatures
E) Chemical characterization of biologics is easily accomplished using analytical chemistry techniques
A) Biologics include growth factors, antibodies, and vaccines
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?
A) Tongue depressor
B) Baby aspirin
C) Lab microwave
D) Pregnancy test kit
E) Dental floss
D) Pregnancy test kit
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 indication
B) Same active ingredient
C) Same route of administration
D) Same dosage form
E) Same artificial sweetener
E) Same artificial sweetener
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) Intravenous
B) Sucrose
C) Elixir
D) Syrups
E) Cream
F) Capsules
B) Sucrose
Prior to release for marketing, one critical quality attribute of any drug product that needs to be met is strength. What is not a unit of strength?
A) Number of tablets per container
B) International units or IU
C) Weight of the API per capsule
D) Amount of API per unit volume
E) Weight of the API per tablet
A) Number of tablets per container
________________ means any ingredient used in the manufacture of a drug product, including those that may not appear in the marketed drug product.
A) Component
B) Inactive ingredients
C) Dosage form
D) Active pharmaceutical ingredient
E) Excipient
A) Component
What is not true of biosimilars?
A) A biosimilar comes in the same strength and mode of administration as a branded biologic
B) For biosimilars, PREA requirements for testing in children are waived
C) Biosimilars are not meaningfully different from the branded product in terms of safety and efficacy
D) A biosimilar has the same active ingredient as branded biologic
E) Clinical trials, with children as subjects, are required
E) Clinical trials, with children as subjects, are required
The first biosimilar approved for marketing in the US is Zarxio, a recombinant form of human G-CSF (colony stimulating factor) used to stimulate white blood cell production after chemotherapy or radiotherapy against cancer. The recombinant protein was produced using what host?
A) Carrot cells
B) Escherichia coli
C) Mammalian cells
D) The yeast, Saccharomyces cerevisiae
E) Insect cells
B) Escherichia coli
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) Smaller patient numbers are required for clinical trials
C) No other version of the drug will be approved during a seven-year market exclusivity
D) Clinical research subsidies are provided
E) PDUFA fees are reduced by 10%
E) PDUFA fees are reduced by 10%
Drug products are reviewed either by FDA’s Center for Drug Evaluation and Research (CDER), or the Center for Biologics Evaluation and Research. Which of these products are reviewed and regulated by CBER?
A) Antibodies
B) Growth factors
C) Gene therapy products
D) Immunomodulators
E) Interferons
C) Gene therapy products
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) Indication
B) Active pharmaceutical ingredient
C) Abuse
D) Component
E) Prescription
A) Indication
What does not fall under the main responsibilities of the manufacturing group?
A) Identify possible risks and challenges for product development
B) Have the product ready for commercialization by a certain target date
C) Develop manufacturing expertise to support the clinical program
D) Develop process to produce the product at reasonable cost
E) Determine the financial value of product
E) Determine the financial value of product
What is not a valid 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) The currently marketed drug is very expensive
B) For any given drug, more than 50% of patients with a condition may not respond to the existing drug
C) The new drug can be for a cancer that had become resistant to a currently administered drug
D) A new drug that has to be taken once a week for life is preferred over one that will need to be administered just twice in a lifetime
E) A new cancer drug that does not cause nausea will be preferred over an existing one that does
D) A new drug that has to be taken once a week for life is preferred over one that will need to be administered just twice in a lifetime
For their manufacturing plans, many biotech companies do not have the facility, equipment, or skill set for large scale production of drugs needed for phase III trials and have to rely on CMOs. CMO stands for:
A) Commercialization management organization
B) Contract manufacturing organization
C) Consolidated manufacturing organization
D) Contract management organization
E) Chinese mandarin oranges
B) Contract manufacturing organization
From the Roche video, what is the first step in the drug development process?
A) Identifying a molecular target for a candidate drug
B) Generate tests and refine lead to come up with optimized chemical
C) Test safety and tolerability of candidate drug in human clinical studies
D) Conduct pre-clinical safety studies using cell cultures or animals
E) Looking for a starting or lead compound that will act on target
A) Identifying a molecular target for a candidate drug
