Choose the incorrect statement.
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.
During non-clinical trials ❌ must be followed. The main purpose of these is to evaluate ❌. During clinical trials ❌ must be followed. Mainly applies to ❌.
Choose the incorrect statement about research and development.
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.
Choose the incorrect statement about commercial manufacture.
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.
Which of these is not a function of packaging?
Correct dosing
Maintaining sterility
Marketing and protecting against counterfeits
Protection against light, moisture, physical stress, etc
Protection from access
A substandard medicine is one of poor quality due to poor manufacturing conditions while a counterfeit medicine is a fraudulent and illegal fake medicine.
