Drug Development Quiz

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Drug Development Quiz

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Week- 1

Regulatory Considerations When Filing an Investigational New Drug Application Quiz

 

1.
Question 1
An Investigational New Drug (IND) is not required for which of the following?

1 point

  • Studies examining a new route of administration
  • Initiation of clinical studies on a new drug
  • Marketed drugs where the study would use approved doses
  • Studies examining a different indication

2.
Question 2
When an Investigational New Drug (IND) application is “in effect” what does it permit a sponsor to do?

1 point

  • Begin studies in animals
  • Set the price of the drug
  • Begin studies in humans
  • Market the drug

3.
Question 3
Which of the following is a FALSE statement regarding IND safety reporting?

1 point

  • For a fatal or life threatening AE, 1 calendar day to report
  • For a serious or unexpected AE, written notification must be sent to the FDA and investigators
  • For a serious or unexpected AE, 15 calendar days to report
  • For a fatal or life threatening AE, must notify FDA via phone or fax

4.
Question 4
Which kind of drugs take comparatively longer time to develop?

1 point

  • Biologics
  • Small molecular entities
  • Oncolytics

5.
Question 5
According to the lecture, how many drugs reach the pre-clinical stage if a company starts with ~5,000-10,000 lead compounds in pre-discovery stage?

1 point

  • 50
  • 250
  • 1,000
  • 8,000

6.
Question 6
Which countries in the EU have more stringent and scientifically rigorous rules to go through to get approved by EMA? (Choose 2)

1 point

  • Germany
  • France
  • Italy
  • Sweden

7.
Question 7
What can be the potential decisions of an IND review? (Choose 2)

1 point

  • IND may not get approved by FDA
  • Clinical hold may be put on IND at any point of time
  • IND is ‘in effect’ on day 21 if no negative comments are received from FDA

 

 

Clinical Study & Start-up Activities Quiz

1.
Question 1
You have developed inclusion/exclusion (I/E) criteria for a clinical study. Subject enrollment is slow. Based on regulatory guidelines, are you allowed to revise I/E criteria during the course of the study?

1 point

Yes, you can revise I/E criteria

No, you are not allowed to revise I/E criteria

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2.
Question 2
All of the following are required elements of the informed consent form (ICF) EXCEPT:

1 point

Potential risks and benefits

Statistical method used in study

Information about how a drug works

Study purpose

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3.
Question 3
All of the following are required elements of a protocol EXCEPT:

1 point

Identifying study objectives

Requirements to be the study’s primary investigator

Background of target rationale

Defining study inclusion/exclusion criteria

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4.
Question 4
Which of the following are described as the key objectives of a Phase I trial, regardless of drug?

1 point

assess appropriateness of stopping rules

determine inclusion/exclusion recommendations

characterize the pharmacokinetic (PK) profile

assess safety and tolerability

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5.
Question 5
What does FIH stand for?

1 point

Foundational Institute of Health

Fast in Host

First in Human

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6.
Question 6
Which of the following are the 3 MOST important to look at when considering our inclusion/exclusion criteria?

1 point

The potential side-effect profile

The potential for drug abuse

The mechanism of the drug

The potential for drug interaction

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7.
Question 7
True or False: It is required to have an IND before your Phase 1 trial

1 point

False

True

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Week- 2

Clinical Trials: Phase 1 Quiz

 

1.
Question 1
Drug X is an investigational agent for high blood pressure. Which of the following study designs would be appropriate for a first in human (FIH) Phase 1 study?

1 point

A placebo-controlled, single dose in healthy adults

An open-label, single dose in patients with high blood pressure

A placebo-controlled, multiple dose in healthy adults

An open-label, multiple-dose in patients with high blood pressure

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2.
Question 2
Which pharmacokinetic parameter will allow you to determine drug exposure?

1 point

t1/2 (elimination half-life)

AUC (area under the concentration versus time curve)

Tmax (time to maximum concentration)

CL (plasma clearance)

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3.
Question 3
What is the primary objective of a phase I study?

1 point

To determine biologic activity of a drug

To determine drug manufacturing needs

To determine drug efficacy

To determine drug safety and tolerability

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4.
Question 4
Which three people were mentioned as those likely to get together to identify a starting dosage level?

1 point

the FDA expert

the toxicologist

the clinical scientist

the pharmacokinetics scientist

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5.
Question 5
Normally first-in-human studies are conducted in healthy volunteers except (choose 2)

1 point

mentally challenged patients

HIV patients

oncology patients

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6.
Question 6
Which of the following was described as the easiest and most important changes that could have improved the Tegenero Phase 1 study?

1 point

staggering timing of dosage

changing the starting dosage

being close to an ICU

changing the study design

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Clinical Trials: Phase 2 Quiz

1.
Question 1
What is the primary objective of a Phase 2b study?

1 point

Determine a drug’s safety and tolerability profile

Determine drug pharmacokinetics

Establish drug dose ranges for subsequent studies

To establish bioequivalence of a drug

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2.
Question 2
What would be the most optimal drug to develop based on the therapeutic index?

1 point

Drug with a therapeutic index ratio of greater than 10

Drug with a narrow therapeutic index

Drug with a therapeutic index ratio equal to zero

Drug with a therapeutic index ratio less than 1

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3.
Question 3
Which of the following outcome from a phase 2 trial would result in continuation to phase 3?

1 point

Discovery of an irreversible, serious adverse event

Establishing the therapeutic dose of a drug

Placebo providing statistically significant efficacy

Determining therapeutic dose to be 50 grams

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4.
Question 4
Which were two of the things in Phase 2 trials that contribute to greater confidence in your compound

1 point

simulation

mathematical modelling

therapeutic index

use in humans

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5.
Question 5
What is illustrated by the difference between the therapeutic effect and the toxic effect (as pointed at by the blue arrow)?

1 point

Therapeutic index

Efficacy plateau

Dosage rate

Hill curve

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Week- 3

Industry Considerations with Phase III Clinical Trials Quiz

 

1.
Question 1
All of the following are design features of a Phase 3 study EXCEPT?

1 point

 

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2.
Question 2
All of the following are common causes of study delays EXCEPT:

1 point

 

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3.
Question 3
Which of the follow were stated as benefits of medical research? (Choose 3)

1 point

 

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4.
Question 4
Historically drug commercialization was more ________ and today it is more _________.

1 point

 

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5.
Question 5
The current estimate of the cost of the full drug development cycle was stated as being in which range/

1 point

 

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6.
Question 6
Considerations of effect on varying populations usually occurs in what stage trial/

1 point

 

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7.
Question 7
Why is stage 3 study design and execution so important?

1 point

 

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New Drug Application, Filing, Product Labeling Quiz

1.
Question 1
All of the following are required for a U.S. FDA New Drug Application EXCEPT:

1 point

 

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2.
Question 2
All of the following are examples of post-marketing studies EXCEPT:

1 point

 

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3.
Question 3
True or False: When a new drug application is submitted by company X, that is public to company Y.

1 point

 

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4.
Question 4
The two characteristics required for fast track approvals are which?

1 point

 

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5.
Question 5
Increased in interest in pharmacoeconomic data was described as coming from where?

1 point

 

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