Chapter 5 - Drug Development

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Chapter 5 - Drug Development

Chapter 5 quiz. Because we love learning about drug development.


Questions and Answers
  • 1. 
    Please write a short description of how you would use what you learned in this chapter on drug development in a client or consultant meeting. Operations, you got off easy last time, please this time describe something new you learned and, if possible, how you might leverage it in your day to day responsibilities.
  • 2. 
    • A. 

      To verify that a drug is sufficiently safe and effective to be tested in humans.

    • B. 

      To undergo preliminary testing in healthy humans to monitor the effects of the drug.

    • C. 

      To create a basic outline for the larger scale future tests on a widespread population.

    • D. 

      A and B

    • E. 

      B and C

  • 3. 
    On what does Phase 1 clinical testing test?
    • A. 

      Animal subjects

    • B. 

      Healthy human volunteers

    • C. 

      Widespread differentiated population

    • D. 

      People with the target disease/condition

    • E. 

      Large-scale tests in people with the target disease/population

  • 4. 
    On what does Phase 2 clinical trials test?
    • A. 

      Animals

    • B. 

      Healthy human volunteers

    • C. 

      Widespread differentiated population

    • D. 

      People with the target disease/condition

    • E. 

      Large-scale tests in people with the target disease/population

  • 5. 
    On what does Phase 3 trials test?
    • A. 

      Animals

    • B. 

      Healthy human volunteers

    • C. 

      Widespread differentiated population

    • D. 

      People with the target disease/condition

    • E. 

      Large-scale tests in people with the target disease/population

  • 6. 
    What is the approximate ratio of potential compounds the beginning of Development to number of products that ultimately get FDA approval?
    • A. 

      1:10

    • B. 

      1:100

    • C. 

      1:1,000

    • D. 

      1:10,000

  • 7. 
    This is a minor detail, but to hit home the concept of how few drugs make it to market, please fill in the blanks (straight out of the book): For every ________ compounds that enter preclinical testing, only ________ go to clinical development, and only ________ win FDA approval
    • A. 

      1,000, 100, 1

    • B. 

      250, 5, 1,

    • C. 

      1, 5, 250

    • D. 

      1, 100, 1,000

  • 8. 
    On average, it takes ____________ years to do the discovery research and testing to bring a new drug to the market.
    • A. 

      6-9

    • B. 

      9-12

    • C. 

      12-15

    • D. 

      15-18

  • 9. 
    Which one is NOT a reason promising compounds might be abandoned:
    • A. 

      Safety/toxicity issues

    • B. 

      Poor absorption or ineffectiveness

    • C. 

      Manufacturing difficulties

    • D. 

      Generic erosion

    • E. 

      Limited market potential

  • 10. 
    What are the two greatest challenges for the Development team?
    • A. 

      Managing risks and complying with FDA requirements

    • B. 

      Improving time to market and decreasing toxicity

    • C. 

      Accelerating time to market and managing risk

    • D. 

      Complying with FDA requirements and improving efficacy

  • 11. 
    Which is the primary goal/major milestone of preclinical development?
    • A. 

      Filing an IND application with the FDA

    • B. 

      Identifying the target population for the lead compound that is being developed

    • C. 

      Aligning the development process with the strategic aims of the company

    • D. 

      To determine anticipated revenue

  • 12. 
    What is the term for the process that is used to prove that a drug is safe and effective in treating specific conditions in certain patient populations?
    • A. 

      Drug discovery

    • B. 

      Preclinical development

    • C. 

      The patent process

    • D. 

      Clinical development

  • 13. 
    What is the purpose of Phase 1 clinical trials?
    • A. 

      To select a lead compound from a lead series

    • B. 

      To identify a target population.

    • C. 

      To establish the safety of administration to humans

    • D. 

      To test whether the proposed drug actually works

  • 14. 
    What is Proof of Concept (POC)?
    • A. 

      Small-scale trials on 100-150 patients with a target disease

    • B. 

      Demonstrating safety and efficacy during phase 2 clinical trials

    • C. 

      An inclusion in the the patent proposal that patents the research/manufacturing process.

  • 15. 
    What is the primary focus of Phase 3 Clinical testing?
    • A. 

      How to manage costs.

    • B. 

      The collection and analysis of highly specific efficacy end-point data.

    • C. 

      The optimal range of effective dosage.

    • D. 

      The analysis of data results from the small-subset target population.

  • 16. 
    When does a company seek permission to market a product in the US?
    • A. 

      Following the completion of Phase 1

    • B. 

      Following the completion of Phase 2

    • C. 

      Following the completion of Phase 3

    • D. 

      Following the completion of Phase 4

  • 17. 
    Which phase in clinical development is the largest investment of both time and money?
    • A. 

      Phase 1

    • B. 

      Phase 2

    • C. 

      Phase 3

    • D. 

      Phase 4

  • 18. 
    Which department is not primarily involved with the creation of the package insert?
    • A. 

      Marketing

    • B. 

      Clinical Development

    • C. 

      Business Development

    • D. 

      Regulatory Affairs

  • 19. 
    What is considered the foundation of the product's marketing strategy?
    • A. 

      The strategic aims of the company

    • B. 

      The FDA-approved package insert

    • C. 

      The current economic climate

    • D. 

      The disease/condition the product is targeting

  • 20. 
    On which two criteria does the FDA classify NDAs?
    • A. 

      Novelty of the active ingredient and time to market

    • B. 

      Balance between safety and effectiveness

    • C. 

      Novelty of the active ingredient and clinical improvement

    • D. 

      Clinical improvement and effectiveness of product

  • 21. 
    Which is NOT a possible fate of an abandoned drug?
    • A. 

      Out-licensing to other companies

    • B. 

      Archival in company's compound libraries

    • C. 

      Future development may prove effective for treating another condition

    • D. 

      Rewriting the package insert to eliminate a black box warning

  • 22. 
    What is a synonym/description for the Phase 4 trials?
    • A. 

      Post Marketing Surveillance

    • B. 

      Pre Marketing Surveillance

    • C. 

      Pre FDA Approval

    • D. 

      Post FDA Approval

  • 23. 
    • A. 

      Phase 4 trials are typically not randomized/placebo controlled

    • B. 

      Phase 4 trials are typically when the product is finalized and submitted for patent protection

    • C. 

      Phase 4 trials may include new populations in which to test the drug

    • D. 

      Phase 4 trials may include new formulations and/or adjusted dosing regimens

  • 24. 
    Which technique is the less common method used to protect the integrity of clinical trial results?
    • A. 

      Single blinding

    • B. 

      Double blinding

    • C. 

      Randomization

    • D. 

      Placebo and control groups

  • 25. 
    What are Good Clinical Practices (GCP)?
    • A. 

      Regulations set in place by PhRMA that state how clinical trials are supposed to be managed.

    • B. 

      Clinical practices that adhere to the best standards of care.

    • C. 

      Widely accepted standards of practice during clinical trials.

    • D. 

      The FDA's requirements for how trials are conducted and documented.