A. 1

Question 1

Clinical trials phases

Answer 1

1. Safety
2. Efficacy
3. Approval
4. Long term

Question 2

Phase 1

Answer 2

Safety:
Test the medication in a small group of people to check if it is safe for humans

Question 3

Phase 2

Answer 3

Efficacy:
How effective the medication is, how well it works at certain dosages.
These on moderately sized group of individuals effected by the condition

Question 4

Phase 3

Answer 4

Approval:
New medication compared to standart treatment (is it just as good or even better?).
Tested on a much larger group of people.
Replicate exact setting in which medication will be administered in real life (this is the basis for APPROVAL by regulatory organization for market)

Question 5

Phase 4

Answer 5

Long term:
Medication reaches the market
Final phase of safety surveillance (→ are there any long term or rare side effects?)
if unsafe: recall and ban!

Question 6

Drug names

Answer 6

1. Chemical (describing the chemical structure, used in scientific studies; e.g. N-acetyl-p-aminophen)
2. Generic (shortened cersion of the chemical name, used by health professionals; e.g. paracetamol, acetaminophen)
3. Brand/Trade (given by the pharmaceutical companies that make the medication (e.g. tylenol, panadol)

Question 7

Medication development steps:

Answer 7

1. Discovery
2. Principal research
3. Clinical development

Question 8

1. discovery

Answer 8

Candidate compound is picked as possible therapeutic agent for specific disease

Question 9

2. principle research

Answer 9

Compound tested on cell cultures and animals
To check for Serious harm on living organism

Question 10

3. clinical development

Answer 10

Clinical trials
Compound tested on humans
Is it safe and effective in treating diseases?

Question 11

types of trials or studies

Answer 11

Interventional and Observational

Question 12

1. Interventional trials:

Answer 12

the aim is to find out more about a particular intervention, or treatment. A computer puts people taking part into different groups. This is so that the research team can compare the results

Question 13

2. Observational studies:

Answer 13

aim to find out what happens to people in different situations. The research team observes the people taking part, but they don’t influence what treatment people have. The people taking part aren’t put into treatment groups