Drug Evaluation And Regulatory Requirements

15 Questions | Total Attempts: 22

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Drug Evaluation And Regulatory Requirements


Questions and Answers
  • 1. 
    How will you evaluate Amal powder ?
  • 2. 
    Write a note on "Ayurvedic, Siddha and Unani Drugs Technical Advisory Board"
  • 3. 
    Confirmation of drugs identity, determination of purity & quality & detection of nature of adulterant is known as
    • A. 

      Identification 

    • B. 

      Confirmation

    • C. 

      Evaluation

    • D. 

      Determination

  • 4. 
    Acid insoluble ash  values of the  crude determines the
    • A. 

      Physiological ash

    • B. 

      Non Physiological ash

    • C. 

      Cell constituent

    • D. 

      Chemical constituents

  • 5. 
    Heating a drug at 1050C in an oven to a constant weight is known as[Blank]
  • 6. 
    Which is true in case of "The residue remaining after incineration is called as"
    • A. 

      Extract

    • B. 

      Ash

    • C. 

      Both

    • D. 

      Foreign matter

  • 7. 
    India registers under which region according to ICH guidelines for stability testing
    • A. 

      Hot and dry                         

    • B. 

      Hot and humid

    • C. 

      Moderate

    • D. 

      Mediterranean

  • 8. 
    The topics included under ICH are,
    • A. 

      Quality 

    • B. 

      Efficacy

    • C. 

      Safety 

    • D. 

      All

  • 9. 
    For long term (Real time) stability studies as per ICH guidelines with storage condition as controlled room temperature the testing condition is
    • A. 

      30oC & 60% RH for 6 months  

    • B. 

      40oC & 75% RH for 6 months

    • C. 

      25oC & 60% RH for 12 months

    • D. 

      60oC & 75% RH for 2 days

  • 10. 
    For Stress testing stability studies as per ICH guidelines with storage condition as controlled room temperature the testing condition is
    • A. 

      30oC & 60% RH for 6 months  

    • B. 

      40oC & 75% RH for 6 months

    • C. 

      25oC & 60% RH for 12 months

    • D. 

      60oC & 75% RH for 2 days

  • 11. 
    In Real time stability tests, a product is stored at elevated stress conditions (such as temperature, humidity, and pH)
    • A. 

      True

    • B. 

      False

  • 12. 
    Any Ayurvedic, Siddha or Unani drug--deemed to be misbranded under section 33EE.
    • A. 

      True

    • B. 

      False

  • 13. 
    Any Ayurvedic, Siddha or Unani drug-deemed to be adulterated under section 33EE
    • A. 

      True

    • B. 

      False

  • 14. 
     "                                                               " is a person according to 33F ,appointed by Central or State government  , by notification in the official Gazette,  with the prescribed qualification and does not have any financial interest in manufacturing and sale of ASU drugs.
  • 15. 
    The Drug and Cosmetics act was amended to include Ayurveda and Unani drugs in the year --
    • A. 

      1940

    • B. 

      1945

    • C. 

      1964

    • D. 

      1946

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