Untitled Flashcards Set

Question 1

1 / 1 pts

According to the Roche video on target identification, there are several approaches to finding a candidate drug target. What is not one of Roche approach?

Correct!

Identifying what enzyme is involved in changing a drug to a less active chemical derivative

Phenotypic screening - Changing one gene at a time in cells of an organism and see whether the mutation leads to a disease state

Using proteomics to Identify which proteins bind to or interact with an active drug

Identify the protein target of a known drug, like aspirin

Comparing genes of healthy and diseased individuals to find the defective gene responsible for the disease

Question 2

1 / 1 pts

Roche video on target identification. Practically all medicine in use today interacts with a protein target by:

inhibiting the function of the protein target

all the other answers are incorrect as drugs don't interact with protein targets

Correct!

either inhibiting or increasing the activity of a protein target

neither inhibiting nor boosting the activity of the protein target

increasing the activity of the protein target

Question 3

1 / 1 pts

As part of in vitro, pre-clinical research, the Ames test is performed using bacteria to determine which property of a candidate drug?

The ability of a drug to cause elevation of liver enzyme activity in mice

The ability of a drug to kill test animals

The ability of a drug to increase heart rate in trial animals

Correct!

The ability of a drug to produce DNA lesions

The ability of a drug to cause abortion in a pregnant mouse

Question 4

1 / 1 pts

What applies to FDA's rules on pre-clinical testing of investigational drugs on animals?

Correct!

Companies do not need FDA permission to initiate tests of drugs on animals even if the data will be used for marketing approval

FDA's Modernization Act 2.0 of 2022 require that all investigational drugs need to be tested for safety on animals before they are tested on humans

Organs on chips are not acceptable alternatives to toxicity testing on animals

Investigators do not need to comply with Good Laboratory Practices during the conduct of animal tests, if the test results will not be used for filing for drug marketing

With FDA's Modernization Act 2.0 of 2022, companies do not have the right to perform tests of investigational drugs on animals

Question 5

1 / 1 pts

Choose the best answer. If required by FDA, in pre-clinical animal testing, the FDA would usually expect biologics to be tested in:

Two small and two large mammals

One small mammal and one large mammal like a dog

Use mice and men

One mammal

Correct!

One small mammal and a primate

Question 6

1 / 1 pts

One type of pre-clinical research experiment is in vitro research. What does not apply to in vitro research?

Developing a small-scale process for drug synthesis that can be scaled up

Correct!

Determining changes in weights of rat organs

Optimizing the chemical structure of a drug candidate to improve its safety profile

Developing a colorimetric bioassay to assess ability of a drug to inhibit a protein’s activity

Determining in test tubes as to which human enzyme is inhibited by a candidate drug

Question 7

1 / 1 pts

Which is not true of Good Laboratory Practices?

GLP regulations are found in CFR21 Part 58

Made up of regulations and guidances that govern laboratory studies in animals

Correct!

Started with deaths of test animals due to excessive bleeding from warfarin

GLPs protect the integrity and quality of pre-clinical laboratory data submitted to the FDA

Followed for any lab activity that will be used to support product submission to FDA

Question 8

1 / 1 pts

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?

The shared GLP principles will help eliminate trade barriers for tested chemicals among member countries

OECD sets standards for the management of testing facilities and reporting of study results

Correct!

OECD stands for Organization for Economic Cooperation and Divestment

The OECD is involved with GLP regulations but does not operate under the US FDA

The GLPs and monitoring will promote mutual acceptance of non-clinical safety data for drug submissions in member countries.

Question 9

1 / 1 pts

The main goal of pre-clinical animal testing is to determine the ______________ to use in initial clinical trials for therapeutics in healthy human volunteers.

Maximum effective starting dose

Minimum effective starting dose

Correct!

Maximum safe starting dose

Minimum toxic starting dose

Minimum safe starting dose

Question 10

1 / 1 pts

Which of the following GLP activities is not the main responsibility of the Quality Assurance unit?

Quality assurance reviews final study reports to ensure accurate listing of the protocols that were followed

Quality assurance checks to be sure that no deviations from approved protocols were made without proper authorization and documentation

Correct!

Quality assurance assigns a principal investigator for each site in multisite pre-clinical studies

Quality assurance is in charge of inspecting and auditing each nonclinical laboratory study

Quality assurance reviews final study reports to ensure that the reported results are accurate

Question 11

1 / 1 pts

What is not compliant with GLP requirements regarding facilities or operation of facilities used for animal testing?

Correct!

Animals of different species should co-mingle in the same room

Mixing of animals used in different studies should be avoided

Facilities should be of suitable size and construction for proper conduct of studies

There should be conditions for proper test article storage

Facilities should have proper separation to avoid contamination

Question 12

1 / 1 pts

What is not a GLP requirement regarding equipment in animal testing laboratories?

Correct!

Equipment should be the best that the company's budget can afford

Written records of equipment use and maintenance should be kept

Equipment needs to be properly cleaned, maintained, and calibrated according to schedule

Protocols for use of the equipment needs to be written and followed

Equipment size and design should be appropriate for its use

Question 13

1 / 1 pts

During pre-clinical research, a starting lead compound usually requires optimization of one or more of its properties. What is a property of a lead compound that researchers attempt to improve?

Correct!

In some diseases, like certain cancers, broaden inhibition of multiple targets

Increase the drug's resistance to inhibition by lead

Increase the drug's excretion by the body

Increasing the drug's adverse health effects

Decrease the drug's absorption by the body

Question 14

1 / 1 pts

What is not correct about the regulation of animal research under the Animal Welfare Act of 1966?

Correct!

The Animal Welfare Act is enforced by Bioresearch Monitoring Office of the FDA

The Animal Welfare Act sets standards regarding the housing, feeding, cleanliness, and medical care of research animals

The Animal Welfare Act encourages replacing animals with alternative models where possible

The Animal Welfare Act aims to reduce the number of primates used in animal testing

The Animal Welfare Act states that tests and experiments should be refined to ensure the best conditions for the animals

Question 15

1 / 1 pts

What applies to an animal facility that had been disqualified by the FDA for serious GLP violations?

Study sponsor can still use information that were generated with non-GLP compliant practices

The non-compliant facility is not entitled to a regulatory hearing

The facility will be forever banned from conducting animal tests

Correct!

Studies completed in the testing site may not be considered in support of application for marketing.

There are no corrective actions that a disqualified facility can take to be reinstated and allowed to operate