Development of drug testing

Question 1

What are the stages in order of drug testing?

Answer 1

1. Pre-clinical testing
2. Clinical trials phase I
3. Clinical trials phase II
4. Clinical trials phase III
5. After licensing

Question 2

What happens in pre-clinical testing?

Answer 2

Compound is tested on animals/isolated cells or tissues then application for human testing is authorised

Question 3

What happens in clinical trial phase I?

Answer 3

A small group of healthy volunteers are given the different doses of the drug to see if it is absorbed, distributed, metabolised and secreted as predicted

Question 4

Clinical trials phase III?

Answer 4

A large group of patients is selected and divided randomly into 2 groups - half take drug half take placebo

Question 5

What happens in clinical trials phase II?

Answer 5

Large group of patients take the drug and effectiveness is measured

Question 6

What happens in after licensing?

Answer 6

Trials continue to measure safety and effectiveness

Question 7

Give four reasons why a contemporary drug testing protocol is an improvement on the trial used
by William Withering

Answer 7

• There is now pre testing on tissues and cells
• More reliable as more people are being tested on
• More valid as we can now compare to a placebo
• More valid because of double-blind trials

Question 8

Explain why healthy volunteers were given different doses of the drug or a placebo

Answer 8

• Check for side effects
• Used different doses to determine safe dose
• Placebo so that any side effects described were due to the drug