Fpharm: principles of drug development-Not completed

Question 1

What does marketing authorisation depend on for a drug?

Answer 1

1. Safety
2. Quality
3. Efficacy

Question 2

What is safety in marketing authorisation?

Answer 2

determines the relative risk for use and handling

Question 3

What is quality in marketing authorisation?

Answer 3

that the drug is manufactured in a strictly controlled way and can be
stored stably

Question 4

What is efficacy in marketing authorisation?

Answer 4

that the drug produces a beneficial effect

Question 5

How does the discovery programme in the pathway to new medicine begin?

Answer 5

thinking forwards, working backwards