Mer Scott
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PHCY211 (Molecules) Quiz on MO4 Drug Development, created by Mer Scott on 07/04/2018.

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Mer Scott
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MO4 Drug Development

Question 1 of 6

1

Choose the incorrect statement.

Select one of the following:

  • A quality drug has an API which is safe and efficacious.

  • A quality drug is fit for intended use.

  • A quality drug refers to the API, not the dosage and packaging.

Explanation

Question 2 of 6

1

During non-clinical trials must be followed. The main purpose of these is to evaluate .
During clinical trials must be followed. Mainly applies to .

Drag and drop to complete the text.

    GLP (Good Laboratory Practice)
    GCP (Good Clinical Practice)
    animal toxicology
    efficacy in patients

Explanation

Question 3 of 6

1

Choose the incorrect statement about research and development.

Select one of the following:

  • There is a focus on improving efficacy.

  • There are small scale reactions (mg to g).

  • There is a focus on optimising the drug's synthetic procedure.

  • There is not much focus on the cost of the synthesis.

Explanation

Question 4 of 6

1

Choose the incorrect statement about commercial manufacture.

Select one of the following:

  • There is a focus on being cost efficient and improving time to synthesis

  • Reactions are 'scaled up' (g to kg) and this comes with safety, purity and yield issues

  • There is an emphasis on improving efficacy and chemical properties.

Explanation

Question 5 of 6

1

Which of these is not a function of packaging?

Select one of the following:

  • Correct dosing

  • Maintaining sterility

  • Marketing and protecting against counterfeits

  • Protection against light, moisture, physical stress, etc

  • Protection from access

Explanation

Question 6 of 6

1

A substandard medicine is one of poor quality due to poor manufacturing conditions while a counterfeit medicine is a fraudulent and illegal fake medicine.

Select one of the following:

  • True
  • False

Explanation

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