4.2.8 - Development Of Drug Testing Flashcards
Why Do New Drugs Need To Be Tested When They Are Developed?
Test for effectiveness and any potential side effects.
Describe William Witherings Digitalis Soup
(5 Points)
~ 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 parents 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.
Describe The Modern Methods Of Drug Testing
(5 Points)
~ 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.
How Many Phases Are There In The Clinical Trials?
3.
Describe Phase 1 Of The Clinical Trials
(2 Points)
~ 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.
Describe Phase 2 Of The Clinical Trials
(2 Points)
~ 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.
Describe Phase 3 Of The Clinical Trials
(2 Points)
~ 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.
Describe Placebos During The Clinical Trials
(4 Points)
~ 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.
Describe Double Blind Studies During The Clinical Trials
(3 Points)
~ 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.