Making medicines Flashcards
what do new drugs have to be tested for? (3)
Safety= This is important as some drugs are toxic, and have other side effects that might be harmful to people.
Effectiveness= This is also known as efficacy, and checks how well the drug cures the disease, or improves symptoms.
Dosage= This varies, and has to closely controlled, as too high a concentration might be toxic.
what are the three main stages of drug testing?
pre-clinical drug trials
animal trials
human trials
describe ‘pre-clinical drug trials’:
and what does this allow us to do?
-drugs are tested using computer models and human cells grown in the laboratory.
test the efficacy and possible side effects of the drug
why do many drugs fail the pre-clinical drug trials?
Many substances fail this test because they damage cells or do not seem to work.
describe ‘animal drug trials’
giving a known amount of the substance to the animals, then monitoring them carefully for any side-effects.
describe ‘human clinical trials’: (2)
-tested on healthy volunteers to check that they are safe.
-the substances are then tested on people with the illness to ensure that they are safe and that they work.
describe how dosages are determined in human drug trials:
Low doses of the drug are used initially, and if this is safe the dosage increases until the optimum dosage is identified.
what are monoclonal antibodies?
identical copies of one type of antibody.
describe the Formation of monoclonal antibodies: (5)
1- antigen is injected into a mouse.
2- mouse naturally produces lymphocytes, which produce antibodies specific to the antigen.
3- Spleen cells which produce the lymphocytes are removed during a small operation.
4- The spleen cells are fused with human cancerous white blood cells called myeloma cells to form hybridoma cells.
5- These hybridoma cells divide and produce millions of monoclonal antibodies specific to the original antigen.
what happens to lymphocytes when they start making antibodies?
Lymphocytes can no longer divide once it has started to make antibodies.
why are cancer cells used to produce monoclonal antibodies?
they divide indefinitely.
why are the hybridoma cells special?
they have the characteristic of the lymphocyte in producing antibodies and the cancerous cell in the ability to divide over and over again.
how do pregnancy kits work?
use monoclonal antibodies which bind with a hormone called HCG which is found only in the urine of pregnant women.
describe the process by which monoclonal antibodies work in pregnancy kits? (3)
-what change will this cause to the kit?
-monoclonal antibodies are attached to the end of a pregnancy test stick onto which a woman urinates.
-if she is pregnant, HCG will be present in her urine and will bind to the monoclonal antibodies on the test stick.
-a change in colour or pattern which will indicate pregnancy. These specific monoclonal antibodies in the pregnancy test will only bind with HCG.
how could we identify a cancerous tumour using monoclonal antibodies? (3)
-cancerous cells have antigens on their surface.
-monoclonal antibodies can be designed to bind specifically with these antigens.
-when injected into a person’s body, the monoclonal antibodies will bind with these cancer cells and clump them together, making them easy to identify
