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Question 1
Question
Choose the incorrect statement.
Answer
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A quality drug has an API which is safe and efficacious.
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A quality drug is fit for intended use.
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A quality drug refers to the API, not the dosage and packaging.
Question 2
Question
During non-clinical trials [blank_start]GLP (Good Laboratory Practice)[blank_end] must be followed. The main purpose of these is to evaluate [blank_start]animal toxicology[blank_end].
During clinical trials [blank_start]GCP (Good Clinical Practice)[blank_end] must be followed. Mainly applies to [blank_start]efficacy in patients[blank_end].
Answer
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GLP (Good Laboratory Practice)
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GCP (Good Clinical Practice)
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animal toxicology
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efficacy in patients
Question 3
Question
Choose the incorrect statement about research and development.
Answer
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There is a focus on improving efficacy.
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There are small scale reactions (mg to g).
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There is a focus on optimising the drug's synthetic procedure.
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There is not much focus on the cost of the synthesis.
Question 4
Question
Choose the incorrect statement about commercial manufacture.
Answer
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There is a focus on being cost efficient and improving time to synthesis
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Reactions are 'scaled up' (g to kg) and this comes with safety, purity and yield issues
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There is an emphasis on improving efficacy and chemical properties.
Question 5
Question
Which of these is not a function of packaging?
Answer
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Correct dosing
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Maintaining sterility
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Marketing and protecting against counterfeits
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Protection against light, moisture, physical stress, etc
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Protection from access
Question 6
Question
A substandard medicine is one of poor quality due to poor manufacturing conditions while a counterfeit medicine is a fraudulent and illegal fake medicine.
Answer
- True
- False
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