CSB601 Introduction Questions with Correct
Answers
What is the significance of Quality Use of Medicines (QUM) in CSB601?
QUM promotes the safe, effective, and appropriate use of medicines in patient care.
What is the role of the Therapeutic Goods Administration (TGA)?
To regulate the supply, import, export, and manufacturing/advertising of therapeutic goods in
Australia.
What types of products does the TGA classify as therapeutic goods?
Medications, supplements, complementary medicines, medical devices, tests and diagnostic
materials, vaccines, biologic products, sunscreen, and surgical implants.
What does AUST L indicate in terms of therapeutic goods?
Listed medicine: low risk, where safety and quality are assessed but no evidence is assessed.
What does AUST R indicate in terms of therapeutic goods?
Registered medicine: high risk, where safety, quality, and evidence are all assessed.
What is the definition of an active ingredient in a medicine?
The chemical in the medicine that has a therapeutic effect or 'makes it work.'
What is a brand name in the context of pharmaceuticals?
A memorable name used by manufacturers for a medicine, often the first patented name.
What is required for generic medicines in terms of bioequivalence?
They must deliver the same active ingredient into the body at a similar rate and extent as the
reference (brand) medicine.
Answers
What is the significance of Quality Use of Medicines (QUM) in CSB601?
QUM promotes the safe, effective, and appropriate use of medicines in patient care.
What is the role of the Therapeutic Goods Administration (TGA)?
To regulate the supply, import, export, and manufacturing/advertising of therapeutic goods in
Australia.
What types of products does the TGA classify as therapeutic goods?
Medications, supplements, complementary medicines, medical devices, tests and diagnostic
materials, vaccines, biologic products, sunscreen, and surgical implants.
What does AUST L indicate in terms of therapeutic goods?
Listed medicine: low risk, where safety and quality are assessed but no evidence is assessed.
What does AUST R indicate in terms of therapeutic goods?
Registered medicine: high risk, where safety, quality, and evidence are all assessed.
What is the definition of an active ingredient in a medicine?
The chemical in the medicine that has a therapeutic effect or 'makes it work.'
What is a brand name in the context of pharmaceuticals?
A memorable name used by manufacturers for a medicine, often the first patented name.
What is required for generic medicines in terms of bioequivalence?
They must deliver the same active ingredient into the body at a similar rate and extent as the
reference (brand) medicine.
