Drug Development Quiz Answer. In this post you will get Quiz Answer Of Drug Development
Drug Development Quiz
Offered By ”University of California San Diego”
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
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
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
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
5.
Question 5
What does FIH stand for?
1 point
Foundational Institute of Health
Fast in Host
First in Human
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
7.
Question 7
True or False: It is required to have an IND before your Phase 1 trial
1 point
False
True
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
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)
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
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
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
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
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
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
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
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
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
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
2.
Question 2
All of the following are common causes of study delays EXCEPT:
1 point
3.
Question 3
Which of the follow were stated as benefits of medical research? (Choose 3)
1 point
4.
Question 4
Historically drug commercialization was more ________ and today it is more _________.
1 point
5.
Question 5
The current estimate of the cost of the full drug development cycle was stated as being in which range/
1 point
6.
Question 6
Considerations of effect on varying populations usually occurs in what stage trial/
1 point
7.
Question 7
Why is stage 3 study design and execution so important?
1 point
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
2.
Question 2
All of the following are examples of post-marketing studies EXCEPT:
1 point
3.
Question 3
True or False: When a new drug application is submitted by company X, that is public to company Y.
1 point
4.
Question 4
The two characteristics required for fast track approvals are which?
1 point
5.
Question 5
Increased in interest in pharmacoeconomic data was described as coming from where?
1 point
