Testing Medicinal Drugs Flashcards
What has to happen to drugs before they can be released to the public?
They have to go through a thorough testing procedure
What are the 3 main stages in drug testing?
- Drugs are tested on human cells and tissue in the lab
- Drugs are tested on live animals
- If pass tests on animals tested on human volunteers in a CLINICAL TRIAL
Name an exception to the human cell/ tissue testing stage
(+ example)
If the drugs affects whole or multiple body systems
e.g. test for blood pressure must be done on a whole animal because it has an intact circulatory system
What does testing a drug on liev animals do?
(3)
- To see whether it works
- To find out about its toxicity
- To find the best dosage
What does the law in Britatin say about animal testing?
That new drugs must be tested on 2 different live mammals
Name 2 opinions on animal testing
- It’s cruel
- It’s the safest way to make sure a drug isn’t dangerous before it’s given to humans
Why do some people argue that animal testing is pointless?
Because they say animals are so different from humans that testing on animals is pointless
What are the 2 stages to the clinical trials?
- Healthy human volunteers
- People suffering from the illness in two groups
What happens in the healthy human volunteer trial?
What happens to dosage?
- Testing for any harmful side-effects when the body is working normally
- Low dose at start then increased gradually
What needs to happen in the healthy human trials for the testing to move on?
The results have to be good
What is found when the drug is tested on people suffering from the illness?
The optimum dosage
(most effective dosage with least side-effects)
Why are patients put into 2 groups?
To test for the placebo effect
Explain how the placebo effect is tested for
- Patients split into 2 groups
- One is given new drug, other is given a placebo
- So the doctor’s can see the actual difference the drug makes
What is the placebo effect?
When a patient feels better because they expect the treament to work, even though the treatment isn’t doing anything
Define ‘blind’ and ‘double-blind’ trials
Blind trials are when the patients don’t know if they are taking the drug or the placebo
Double-blind trials are when the doctors don’t know either
Why do we use double-blind trials?
So the doctors monitoring the patients and analysing the results aren’t subconsciously influenced by their knowledge
Name a drug that caused problems because it wasn’t thoroughly tested
When developed?
Thalidomide
1950s
What was thalidomide intended and tested to be used as?
A sleeping pill
What was thalidomide used for that it was not tested for?
Relieving morning sickness in pregnant women
What happened as a result of thalidomide not being used and not tested as a reliever of morning sickness?
No one knew it could pass through the placenta and affect the fetus, causing abnormal limb development.
About how many babies were affected by thalidomide, and about how many survived?
About 10 000 affected
Only about half survived
What happened as a result of finding the problems with thalidomide?
(2)
- It was banned
- More rigorous testing procedures were introduced
What has thalidomide more recently been used in the treatment of?
(2ish)
- Leprosy
- Other diseases e.g. some cancers
