BTEC 3317 Quiz 7

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?

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

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

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

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

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

3 multiple choice options

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

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

Inhibiting the function of the protein target

Either inhibiting or increasing the activity of a protein target

3 multiple choice options

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 kill test animals

The ability of a drug to produce DNA lesions

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

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

The ability of a drug to produce DNA lesions

3 multiple choice options

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

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

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

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

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

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

3 multiple choice options

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

One mammal

Two small and two large mammals

One small mammal and one large mammal like a dog

One small mammal and a primate

One small mammal and a primate

3 multiple choice options

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

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

Determining changes in weights of rat organs

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

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

Determining changes in weights of rat organs

3 multiple choice options

Which is not true of Good Laboratory Practices?

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

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

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

GLP regulations are found in CFR21 Part 58

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

3 multiple choice options

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?

OECD stands for Organization for Economic Cooperation and Divestment

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

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

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

OECD stands for Organization for Economic Cooperation and Divestment

3 multiple choice options

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

Minimum safe starting dose

Maximum safe starting dose

Maximum effective starting dose

Minimum effective starting dose

Maximum safe starting dose

3 multiple choice options

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

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

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

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

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

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

3 multiple choice options

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

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

Mixing of animals used in different studies should be avoided

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

Facilities should have proper separation to avoid contamination

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

3 multiple choice options

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

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

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

Equipment size and design should be appropriate for its use

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

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

3 multiple choice options

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?

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

Increase the drug's excretion by the body

Decrease the drug's absorption by the body

Increasing the drug's adverse health effects

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

3 multiple choice options

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

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 states that tests and experiments should be refined to ensure the best conditions for the animals

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

3 multiple choice options

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

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

The facility will be forever banned from conducting animal tests

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

3 multiple choice options