What is true of biosimilars? - CORRECT ANSWER "Clinical trials, with children as subjects,
are not required for marketing approval of biosimilars
... [Show More] "
"Based on FDA's definition of a drug, what is a drug not supposed to do to a patient's disease or
condition? - CORRECT ANSWER Exacerbate
Which group in a drug development company performs comparability studies or tests of different
product attributes from one manufacturing batch to another? - CORRECT ANSWER Quality
control group
________________ means any ingredient used in the manufacture of a drug product, including
those that may not appear in the marketed drug product. - CORRECT ANSWER Component
Drug product refers to a finished dosage form. What is not considered a dosage form? -
CORRECT ANSWER Inactive ingredient
What does not apply to dietary supplements? - CORRECT ANSWER Dietary supplements
require FDA approval prior to marketing
From the Roche video, what is the first step in the drug development process? - CORRECT
ANSWER Finding proteins whose activity will be good to inhibit with a drug
What is true of biologics? - CORRECT ANSWER includes natural or recombinant protein more
than 40 amino acids long
You're tasked with doing market analysis for the new drug that your company is developing.
What might decrease the future market earnings for your new drug? - CORRECT ANSWER
Patients are reporting that a marketed cancer drug is preventing their relapse much longer than
initially observed during the clinical trials for the drug
What would be a major responsibility of a biotech company's research group? - CORRECT
ANSWER Discovery or design of new drugs
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? - CORRECT ANSWER No other version of the drug will be
approved during a three year market exclusivity
The FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from
industry to fund and speed up reviews of different types of drugs. In the Generic and Biosimilars
UFA, the final user fees are what percent of the typical user fees for a branded drug PDUFA? -
CORRECT ANSWER 10%
What is not true of the inactive ingredients found in drug products? - CORRECT ANSWER
Inactive ingredients do not affect the efficacy properties of a drug product
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? - CORRECT ANSWER Same label
In drug regulation, indication refers to - CORRECT ANSWER the condition that an approved
drug could be used for
As part of in vitro research, the drug candidate is tested using the Ames test for genotoxicity.
Genotoxicity is a test for: - CORRECT ANSWER The ability of a drug to alter the sequence of
DNA
During pre-clinical research, a starting lead compound usually requires optimization of one or
more of its properties. What is not a property of a lead compound that researchers attempt to
optimize? - CORRECT ANSWER Increasing patient dependence on the drug
Lead compounds for drug optimization are either synthetic or derived from naturally available
compounds. In the NPR video, the chemical coumarin in sweet clover hay was converted by a
____________ to a potent chemical which caused uncontrolled internal bleeding in cows due to
blood that wouldn't clot. - CORRECT ANSWER fungus
GLP regulations require that "each individual engaged in the conduct, or responsible for the
supervision, of a nonclinical laboratory study shall have __________________ to enable that
individual to perform the assigned functions. - CORRECT ANSWER Education, training and
experience
According to the Roche video on target identification, there are at least 3 approaches to finding a
candidate drug target. What is not one of the three? - CORRECT ANSWER Identifying how the
drug gets broken down in the bloodstream
The main goal of pre-clinical animal testing is to determine the ______________________ to
use in initial clinical trials for therapeutics in healthy human volunteers. - CORRECT ANSWER
Highest safe starting dose
What is not compliant with GLP requirements regarding facilities or operation of facilities used
for animal testing? - CORRECT ANSWER Facilitites should be suitable for the placement of
cats and mice in the same area
What is not correct about the regulation of animal research under the Animal Welfare Act of
1966? - CORRECT ANSWER The Animal Welfare Act aims to encourage the use of animals in
testing candidate human drugs
The OECD published a series of principles of Good Laboratory Practices and Compliance
Monitoring. What does not apply to the OECD and the GLP principles? - CORRECT ANSWER
The shared GLP principles are in place to impose trade barriers for tested chemicals among
member countries
One type of pre-clinical research experiment is in vitro research. What does not apply to in vitro
research? - CORRECT ANSWER Determining changes in size or weights of rat organs
Which is not true of Good Laboratory Practices? - CORRECT ANSWER Started with deaths of
test animals due to an antifreeze candidate drug
What information is usually not included in completed animal study reports per GLP? -
CORRECT ANSWER Date the testing facility manager was hired [Show Less]