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Principal Groups of Xenobiotics - Prescription Drugs

Total questions: 10

Worksheet time: 3mins

Name
Class
Date
1.
Counterfeit drugs cause large economic damages to drug manufacturers.
a)
True
b)
False
2.
After litigation with the FDA, Able Laboratories went out of business.

a)
True
b)
False
3.
An FDA Class I defect in a drug is potentially life-threatening.
a)
True
b)
False
4.
The FDA classes of recalls for defective drugs are very different for those used in the European Union.
a)
True
b)
False
5.
Medical devices are never subject to recalls.
a)
True
b)
False
6.
Mass spectrometry is suitable for quality controls to evidence defective or counterfeit drugs.
a)
True
b)
False
7.
Simple colorimetric and spectrophotometric methods can be suitable for quality controls to evidence defective or counterfeit drugs.

a)
True
b)
False
8.
Miltefosine (the antimalarial drug) is the only drug that no one has ever been able to counterfeit.
a)
True
b)
False
9.
Counterfeit antimicrobials can often be discovered by a simple bacterial growth inhibition test
a)
True
b)
False
10.
Drug manufacturers are required by law to respond formally to observationDrug manufacturers are required by law to respond formally to observations included in a “483”.
a)
True
b)
False