Developing drugs Flashcards
What are the three main stages in drug testing?
Preclinical testing on human cells and tissues
Preclinical testing on live animals
Clinical testing on human volunteers
Why do new drugs need to undergo testing procedures?
safe and effective
where is preclinical testing done for cells and tissues?
in the lab
what can’t you use in preclinical testing(cells and tissues)?
human cells and tissues to test drugs that affect whole or multiple body systems.
what is the next step in preclinical testing(after cells and tissues)?
to test the drugs on live animals
why are live animals used in preclinical testing to test for drugs?
to test the efficacy(whether the drug works and produces the effect you’re looking for),to find out about its toxicity(how harmful it is)and to find the best dosage(the concentration that should be given and how often it should be given)
what is societies opinion about the use of live animals for preclinical testing?
- the law in Britain states that any new drug must be tested on two mammals.
- some think it’s cruel to test on animals.
- some believe it is the safest way to test whether a drug is safe
- some people believe that animals are so different humans.
what happens after if a drug has passed the tests on animals?
then it is tested on human volunteers in a clinical trial.
how do clinical trials work?
1.)the drug is tested on healthy volunteers,to make sure that it doesn’t have any harmful side effects when the body is working normally.At the start of the trail, a very small dose of the drug is given and this is gradually increased.
Clinical trial:if the results of the tests on healthy volunteers are good,what will happen next?
the drugs can be tested on people suffering from the illness.The optimum dose is found.
what is the optimum dose?
the dose of drug that is the most effective and has fewer side effects.
How can doctors test how well a drug works?
patients are randomly put into two groups.One group is given the new drug and the other is given a placebo,so the doctor can see the difference the drug makes-it allows for the placebo effect.
what is placebo?
a substance that’s like the drug being tested but doesn’t do anything.
