4.2.8 - Development Of Drug Testing

Question 1

Why Do New Drugs Need To Be Tested When They Are Developed?

Answer 1

Test for effectiveness and any potential side effects.

Question 2

Describe William Witherings Digitalis Soup
(5 Points)

Answer 2

~ He discovered that an extract of foxgloves could be used to treat dropsy (Swelling caused by heart failure).

~ Foxglove is poisonous to humans, so he made different versions of his remedy containing different concentrations of digitalis.

~ These versions were called his digitalis soup.

~ He experimented on his patients to find the most effective concentration of digitalis, that would treat dropsy without poisoning the patient.

~ Through trial and error, he discovered the right amount to give a patient.

Question 3

Describe The Modern Methods Of Drug Testing
(5 Points)

Answer 3

~ There a much more controlled then those of the past.

~ First Step -> Modelling potential side effects of the drug, using computers.

~ Second Step -> Drug is then tested on human tissues, before being tested on animals.

~ Third Step -> Testing on live animals begin.

~ If the drug passes these steps, it will then continue onto the clinical trial stage, where the drug is tested on live humans.

Question 4

How Many Phases Are There In The Clinical Trials?

Answer 4

3.

Question 5

Describe Phase 1 Of The Clinical Trials
(2 Points)

Answer 5

~ Testing the new drug on a small group of healthy individuals.

~ This is done to determine how the body will react to the drug, side effects and correct dosage.

Question 6

Describe Phase 2 Of The Clinical Trials
(2 Points)

Answer 6

~ New drug is tested on a larger group of patients, these people are not healthy and require the drug.

~ This is done to determine the effectiveness of the drug.

Question 7

Describe Phase 3 Of The Clinical Trials
(2 Points)

Answer 7

~ Involves comparing the new drug to existing drugs, to see if it works any better.

~ Large number of patients are split into 2 groups, each of which receives the new drug or the existing one.

Question 8

Describe Placebos During The Clinical Trials
(4 Points)

Answer 8

~ Typically done during phase 2 of the clinical trial.

~ Patients are split into 2 groups, one will receive the drug the other will receive a placebo.

~ Providing a way for scientists to determine whether the drug works.

~ Certain patients develop a placebo effect, where patients show improvements in their health due to the belief they are receiving the drug.

Question 9

Describe Double Blind Studies During The Clinical Trials
(3 Points)

Answer 9

~ Happen during phase 2 and 3 of the clinical trials.

~ Neither patient or doctor knows which patient is receiving the drug or the placebo.

~ Reduces the bias in the attitudes of either doctor or patient in the developing results.