Drug Development Quiz

15 Questions | Total Attempts: 34116

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Drug Development Quiz

Here is a Drug Development quiz for those who love learning about the research, testing, and manufacturing process required to bring a new drug in the market. Take this quiz, answer these questions, and not only will you test your knowledge, but you will also learn many things from here. Best of luck!


Questions and Answers
  • 1. 
    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

  • 2. 
    On what do 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

  • 3. 
    On what do 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

  • 4. 
    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

  • 5. 
    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

  • 6. 
    What are the two greatest challenges for the Development team?
    • A. 

      Managing risks and complying with FDA requirements

    • B. 

      Improving the time to market and decreasing toxicity

    • C. 

      Accelerating time to market and managing risk

    • D. 

      Complying with FDA requirements and improving efficacy

  • 7. 
    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.

  • 8. 
    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

  • 9. 
    On which two criteria does the FDA classify NDAs?
    • A. 

      The novelty of the active ingredient and time to market

    • B. 

      The balance between safety and effectiveness

    • C. 

      The novelty of the active ingredient and clinical improvement

    • D. 

      Clinical improvement and effectiveness of the product

  • 10. 
    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

  • 11. 
    What is the major trigger of study delays?
    • A. 

      Budget concerns

    • B. 

      FDA hold-ups

    • C. 

      Recruitment problems

    • D. 

      Safety/toxicity issues

  • 12. 
    Medical Affairs is focused primarily on:
    • A. 

      Trysts with medical professionals

    • B. 

      Approved and launched drugs

    • C. 

      Drugs awaiting FDA approval

    • D. 

      Drugs in the discovery process

  • 13. 
    Approximately what percentage of clinical development studies are conducted by CRO's?
    • A. 

      1-5%

    • B. 

      10-20%

    • C. 

      25-30%

    • D. 

      50-75%

  • 14. 
    What is the approximate ratio of potential compounds at the beginning of Development to the number of products that ultimately get FDA approval?
    • A. 

      1:10

    • B. 

      1:100

    • C. 

      1:1,000

    • D. 

      1:10,000

  • 15. 
    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

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