Clinical research

A detailed and engaging illustration of a laboratory setting with researchers working on drug development, featuring animal testing and safety protocols.

Clinical Research Quiz

Test your knowledge in the field of clinical research with our comprehensive quiz. Designed for professionals and enthusiasts alike, this quiz will challenge your understanding of essential topics including animal toxicology, safety pharmacology, and drug development processes.

22 insightful questions
Multiple-choice format
Covering various aspects of clinical research

22 Questions6 MinutesCreated by TestingTiger512

All are the objectives of animal toxicology studies except_

To assess the systemic exposure achieved in animals and its relationship to dose level and the time course of the toxicity study.

Obtaining data to relate the exposure achieved in toxicity studies to toxicological findings

To support the choice of species and treatment regimen in nonclinical toxicity studies

Perform safety pharmacology studies to rationally select study design for safety assessment.

All of the following animal toxicology tests are required for phase I of clinical trials except_

1. Systemic toxicity studies

2. Hypersensitivity/allergenicity test

3. Carcinogenicity studies

4. In-vitro genotoxicity tests

All are true in the context of specific pharmacological actions except

1. Specific pharmacological actions are those which demonstrate the therapeutic potential for humans.

2. The use of new technologies and methodologies in accordance with sound scientific principles should be preferred.

3. Scientifically validated methods should be used.

4. The study design will not be affected by the individual properties and intended uses of investigational drug.

The aim of essential safety pharmacology studies is to

1. Study the mechanism of action of a drug.

2. Investigate undesirable effects of a substance on the physiology when exposure is below the therapeutic range.

3. To study the effects of the test drug on functions of vital organ systems

4. None of the above

Safety pharmacology studies are not required for a drug

1. Applied locally – with considerable systemic absorption

2. Applied locally – with low systemic absorption

3. Which has related PK/PD from the parent drug it was derived

4. Which undergoes high first pass metabolism

Safety pharmacological studies are done

1. Prior To First Administration In Humans

2. Before applying for marketing Approval

3. During Clinical Development

4. During post marketing surveillance

All documents belonging to each study, including its approved protocol, raw data, draft report, final report, and histology slides and paraffin tissue blocks should be preserved for

1. A minimum of 5 years after marketing of the drug.

2. A minimum of 5 years after phase II

3. A maximum of 5 years after marketing of the drug.

4. A maximum of 5 years after phase II

Why does FDA approval take so long?

Due to the multiple number of tests that a drug undergoes

Due to its strict safety protocols

Due to the limited no. Of drugs that it can approve in a year

All of the above

Avg. Cost to research and develop each successful drug is estimated to be...

$2.6 Billion

$2.6 Million

In the process of drug discovery ________ takes an indefinite time?

Screening of molecules

Target identification

Lead optimization

Assay development

What are knock-out mice?

Those that have been sedated

Those with altered gene

Those with inactivated gene

Those with defective genes

How long does a pre-clinical study for drugs usually last for?

1-2 years

2-4 years

1-6 years

2-6 years

Application of high throughput screening in drug development includes?

Providing information for hit optimization

Determining the structure of the binding site on protein

Foundation for structure-based drug design

All of the above

Which country was granted a compassionate use protocol for the Ebola vaccine?

Morocco

Democratic Republic of Congo

Angola

United Republic of Tanzania

Selection of Development Candidate for a molecule depends on?

Demonstrated in vitro efficiency/activity

Acceptable PD

Acceptable safety margin (toxicity in rodents or dogs)

Option 1 & 3

Which one of these is not a role of Pharmacogenomics in DD?

Drug-drug interaction

Drug resistance

Drug ADME

Drug transporters

Regulatory agencies have recently introduced ______ into the market to ensure safe products are released

Exploratory phase

Regulatory Phase

Clinical phase

Quality check phase

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