They come up with a theory about what causes a disease.
200
How do scientists see if their compounds match the theories to treat the disease?
Using computer models and laboratory tests.
200
What are the two types of tests?
'In vitro' tests
'In vivo' tests
200
How long is patent protected after it's launched?
10 years
200
What happens during phase 1?
Healthy volunteers take a short course of the medicine to experiment.
300
What happens during the target stage?
Scientists target a part of the biological process that causes a problem.
300
Name some requirements that a potential drug needs to meet for further research.
It isn't poisonous.
It will be effective against the disease.
It won't break down too quickly in the body.
No major problems can be foreseen for making it on a large scale.
300
What does 'in vitro' mean?
'In glass" because the test is performed in petri glass and tubes.
300
What does patent protect other companies from?
It protects the companies from marketing the same compound.
300
During phase 1 what are the certain factors you should look for?
1) lowest and highest dose
2) how long each dose works
3) side effects
400
What happens during the discovery stage?
They look for, or design, suitable compounds which might prevent/treat/cure the disease.
400
How much money does it take to develop a new drug?
In 2005, it took 1.3 million every year in the process of producing the drug.
400
What is an 'in vivo' test?
An in vivo test is a test using laboratory animals, and they are a vital safety check.
400
What is most likely to happen when a compound is found?
The company applies for a patent
400
What happens during Phase 2?
Long term studies are done in volunteers, also there are short term studies done in several people probable for the disease. These studies help check how well the medicine works on the disease.
500
What kind of biological problems might be discovered during the target stage?
1) Missing Protein
2) A lack of hormone
3) A defective gene
500
How far along are you in developing a new drug if you're in the selection stage?
The selection process is in the early overall stage of developing a drug.
500
What is an 'in vitro' test?
A stage that uses techniques to look at biological activity and to eliminate all but a few of the original possible compounds.
500
How long does an applicant holder have to submit patent information?
For patents issued after approval of the NDA, the applicant holder has 30 days to file the patent.
500
What happens during Phase 3?
They look for statistical evidence that the compound is effective, what doses will be required, and the potential side effects.