2.4.9 Drug Development

Question 0

What is the first stage of drug testing?

Answer 0

Pre-clinical trials:

- animal studies and laboratory studies in isolated cells and tissues

Question 1

Describe the work of William Withering

Answer 1

He visited a patient who had dropsy. He expected her to die, but she drank some home made tea which cured her. Withering took this tea to Birmingham hospital to test it on more patients and experiment with doses

Question 2

What is the second stage of drug testing?

Answer 2

Clinical trials - phase I:

• a small group of volunteers are given the drug in different doses
• the volunteers are usually healthy
• these trials are to test what the body actually does with the drug

Question 3

What is the third stage of drug testing?

Answer 3

Clinical trials - phase II:

• 100-300 volunteer patients are treated with the drug
• this phase looks at the effectiveness of the drug

Question 4

What is the fourth stage of drug testing?

Answer 4

Clinical trials - phase III:

• 1000-3000 patients are selected and divided into two groups
• one group is given a placebo and the other is given a drug
• this is a ‘double blind trial’, meaning neither patient or doctor know who’s having the placebo

Question 5

What is the final stage of drug testing?

Answer 5

After licensing:

- trials continue to collect data in the effectiveness of the drug