topic 4

Question 1

4.13 Drug Testing Phases

Answer 1

1. Discovery
2. Pre-clinical trials (animal testing)
3. Phase 1 Clinical Trials (human testing - side effects)
4. Phase 2 Clinical Trials (human testing - dose)
5. Phase 2 Clinical Trials (large group testing)
6. Monitoring

Question 2

4.13 Discovery stage of drug testing

Answer 2

• find active ingredient

- test on computer models

Question 3

4.13 Pre-clinical trial stage of drug testing

Answer 3

• check for efficacy and toxicity (range of concentrations)

- test on animals and human tissues

Question 4

4.13 Phase 1 clinical trial stage of drug testing

Answer 4

healthy paid volunteers

• low concentration to check for side effects
• effect of different doses are monitored

Question 5

4.13 Phase 2 clinical trial stage of drug testing

Answer 5

• tested on a small group of volunteer patients

- checks for effectiveness of the drug

Question 6

4.13 Phase 3 clinical trial stage of drug testing

Answer 6

• tested on a large group of patients
• randomised trial
• increases reliability when checking efficacy
• placebo and double blind trials

Question 7

4.13 Monitoring stage of drug testing

Answer 7

• drug is monitored even after licensing
• rare or long term side effect of drug
• trials continue to collect data results

Question 8

4.13 Ensuring validity (placebo)

Answer 8

• same method of delivery as drug is being tested without the active ingredient
• prevents “placebo effect”
• psychosomatic influence skewing the results

Question 9

4.13 Ensuring validity (double blind trial)

Answer 9

• neither doctor or patient know who is receiving which drug

- prevents bias

Question 10

4.13 Ethical issues regarding animal testing (For)

Answer 10

• allows to identify toxicity before testing on humans
• use a range of concentration to determine dose
• heavily regulated to prevent suffering
• no harm to humans

Question 11

4.13 Ethical issues regarding animal testing (Against)

Answer 11

• animal’s biochemistry and physiology is not the same as humans
• animals have no choice
• unethical to cause harm to animals

Question 12

4.14 Conditions required for bacterial growth

Answer 12

• source of nutrients needed to respire and grow
• (aerobic respiration) need a supply of oxygen
• temperature and pH must be controlled
  if either of these factors is too high or too low it can affect enzyme activity, meaning metabolic processes (e.g. respiration) can’t take place normally