All Weeks Drug Development Coursera Quiz Answers
In this course, you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally, you will learn how to Incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas.
Drug Development Week 01 Quiz Answers
Regulatory Considerations When Filing an Investigational New Drug Application Quiz Answers
Q1. An Investigational New Drug (IND) is not required for which of the following?
- Initiation of clinical studies on a new drug
- Studies examining a new route of administration
- Marketed drugs where the study would use approved doses
- Studies examining a different indication
Q2. When an Investigational New Drug (IND) application is “in effect” what does it permit a sponsor to do?
- Begin studies in animals
- Market the drug
- Begin studies in humans
- Set the price of the drug
Q3. Which of the following is a FALSE statement regarding IND safety reporting?
- For a serious or unexpected AE, 15 calendar days to report
- For a serious or unexpected AE, written notification must be sent to the FDA and investigators
- For a fatal or life threatening AE, 1 calendar day to report
- For a fatal or life threatening AE, must notify FDA via phone or fax
Q4. Which kind of drugs take comparatively longer time to develop?
- Small molecular entities
Q5. 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?
Q6. Which countries in the EU have more stringent and scientifically rigorous rules to go through to get approved by EMA? (Choose 2)
Q7. What can be the potential decisions of an IND review? (Choose 2)
- IND is ‘in effect’ on day 21 if no negative comments are received from FDA
- IND may not get approved by FDA
- Clinical hold may be put on IND at any point of time
Clinical Study & Start-up Activities Quiz Answers
Q1. ou 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?
- No, you are not allowed to revise I/E criteria
- Yes, you can revise I/E criteria
Q2. All of the following are required elements of the informed consent form (ICF) EXCEPT:
- Study purpose
- Information about how a drug works
- Statistical method used in study
- Potential risks and benefits
Q3. All of the following are required elements of a protocol EXCEPT:
- Identifying study objectives
- Background of target rationale
- Requirements to be the study’s primary investigator
- Defining study inclusion/exclusion criteria
Q4. Which of the following are described as the key objectives of a Phase I trial, regardless of drug?
- assess safety and tolerability
- determine inclusion/exclusion recommendations
- characterize the pharmacokinetic (PK) profile
- assess appropriateness of stopping rules
Q5. What does FIH stand for?
- Fast in Host
- Foundational Institute of Health
- First in Human
Q6. Which of the following are the 3 MOST important to look at when considering our inclusion/exclusion criteria?
- The potential for drug abuse
- The potential side-effect profile
- The potential for drug interaction
- The mechanism of the drug
Q7. True or False: It is required to have an IND before your Phase 1 trial
Drug Development Week 02 Quiz Answers
Clinical Trials: Phase 1 Quiz Answers
Q1. 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?
- An open-label, single dose in patients with high blood pressure
- A placebo-controlled, single dose in healthy adults
- A placebo-controlled, multiple dose in healthy adults
- An open-label, multiple-dose in patients with high blood pressure
Q2. Which pharmacokinetic parameter will allow you to determine drug exposure?
- CL (plasma clearance)
- AUC (area under the concentration versus time curve)
- t1/2 (elimination half-life)
- Tmax (time to maximum concentration)
Q3. What is the primary objective of a phase I study?
- To determine drug manufacturing needs
- To determine drug efficacy
- To determine drug safety and tolerability
- To determine biologic activity of a drug
Q4. Which three people were mentioned as those likely to get together to identify a starting dosage level?
- the toxicologist
- the pharmacokinetics scientist
- the clinical scientist
- the FDA expert
Q5. Normally first-in-human studies are conducted in healthy volunteers except (choose 2)
- HIV patients
- mentally challenged patients
- oncology patients
Q6. Which of the following was described as the easiest and most important changes that could have improved the Tegenero Phase 1 study?
- staggering timing of dosage
- changing the starting dosage
- being close to an ICU
- changing the study design
Clinical Trials: Phase 2 Quiz Answers
Q1. What is the primary objective of a Phase 2b study?
- Establish drug dose ranges for subsequent studies
- Determine drug pharmacokinetics
- To establish bioequivalence of a drug
- Determine a drug’s safety and tolerability profile
Q2. What would be the most optimal drug to develop based on the therapeutic index?
- Drug with a narrow therapeutic index
- Drug with a therapeutic index ratio less than 1
- Drug with a therapeutic index ratio of greater than 10
- Drug with a therapeutic index ratio equal to zero
Q3. Which of the following outcome from a phase 2 trial would result in continuation to phase 3?
- Discovery of an irreversible, serious adverse event
- Establishing the therapeutic dose of a drug
- Determining therapeutic dose to be 50 grams
- Placebo providing statistically significant efficacy
Q4. Which were two of the things in Phase 2 trials that contribute to greater confidence in your compound
- therapeutic index
- mathematical modelling
- use in humans
Q5. What is illustrated by the difference between the therapeutic effect and the toxic effect (as pointed at by the blue arrow)?
- Therapeutic index
- Dosage rate
- Hill curve
- Efficacy plateau
Drug Development Week 03 Quiz Answers
Industry Considerations with Phase III Clinical Trials Quiz Answers
Q1. All of the following are design features of a Phase 3 study EXCEPT?
- Multi-center sites
- Performance in final dosage form
- Large sample size
- Open-label study
Q2. All of the following are common causes of study delays EXCEPT:
- Patient recruitment
- Earlier safety data
- Legal Review
- Marketing authorization
Q3. Which of the follow were stated as benefits of medical research? (Choose 3)
- Impact on disease prevention
- Informational changes to pharmaceutical research
- Reduction in total burden of chronic disease
- Development of approximate costs for future clinical studies
Q4. Historically drug commercialization was more ________ and today it is more _________.
- parallel, linear
- linear, parallel
- US-driven, global
- global, US-driven
Q5. The current estimate of the cost of the full drug development cycle was stated as being in which range/
- < 500 million
- 500 million to 1 billion
- 1-1.5 billion
- 1.5-2 billion
Q6. Considerations of effect on varying populations usually occurs in what stage trial/
Q7. Why is stage 3 study design and execution so important?
- Assurance of Safety
- Evaluation of Efficacy
- Ability to Commercialize
New Drug Application, Filing, Product Labeling Quiz Answers
Q1. All of the following are required for a U.S. FDA New Drug Application EXCEPT:
- Packaging methods
- Preclinical data
- Human bioavailability
- Disclosure of intent to file in other countries
Q2. All of the following are examples of post-marketing studies EXCEPT:
- Studies of new uses of drug
- Proof of principle study
- Study examining effectiveness in widespread populations
- Safety surveillance study
Q3. True or False: When a new drug application is submitted by company X, that is public to company Y.
Q4. The two characteristics required for fast track approvals are which?
- treats a serious illness
- an advance on existing treatment
- fills an unmet need
Q5. Increased in interest in pharmacoeconomic data was described as coming from where?
- pharmaceutical companies wanting to build better models to guide drug development
- insurance companies wanting to determine if there would be a cheaper standard of care
- the FDA looking to prioritize future application processing
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