Drug Development- Creation Flashcards
What are some advantages of synthesising drugs in a lab?
We can give them a measured dosage, it takes alot of plants to make a small amount of drugs, it is cheaper.
What are the 3 stages of testing for a drug?
- Preclinical drug tests.
- Animal Tests
- Human clinical tests
What happens in preclinical drug trials?
Drugs are tested using computer models and human cells grown in a lab. This tests for efficacy and possible side effects.
What happens in animal trials?
Drugs that pass the first test. All medicines have to undergo this test but cosmetics and tobacco products arn’t allowed. They give a certain amount of the drug to animals and monitor them for side effects.
What happens in human trials?
Drugs that have passed animal tests are used in clinical tests. It has 3 phases.
What is the 1st phase of human trials?
They are tested on a small group of healthy volunteers and focuses on safety.
What is the 2nd phase of human trials.
They are tested on a larger group of people and focus on how the drug is metabolised and to gather data on it.
What is the 3rd phase of human trials?
They are tested on a large group of people with the illness and focus on finding out the efficacy and dosage.
What happens after?
The drug will then be given to the FDA for them to review. If it accepted, the company will then manufacture and sell the drugs.
How long will the entire process take?
12-13 years
How much does the entire process cost?
£1.6 billion
How many people will it take?
Around 1000 people.
