B3- Developing Drugs Flashcards
What are the three main stages in drug testing?
- Preclinical testing 2. Clinical trials 3. Post-marketing surveillance
These stages ensure that drugs are safe and effective before they reach the market.
What is preclinical testing?
Testing drugs on human cells and tissues in the lab, followed by testing on live animals
This stage assesses efficacy, toxicity, and optimal dosage.
Why can’t some drugs be tested solely on human cells and tissues?
Because they affect whole or multiple body systems, requiring an intact circulatory system for testing
For example, blood pressure drugs must be tested on live animals.
What must be done according to the law in Britain regarding new drug testing?
Any new drug must be tested on two different live mammals
This is to ensure safety before testing on humans.
What are the key purposes of testing drugs on live animals?
To test efficacy, determine toxicity, and find the best dosage
This helps ensure that the drug is safe and effective.
What happens after a drug passes animal testing?
It is tested on human volunteers in a clinical trial
This includes testing on healthy volunteers first.
What is the purpose of testing drugs on healthy volunteers?
To ensure there are no harmful side effects when the body is functioning normally
This involves starting with a very low dose that is gradually increased.
What is the optimum dose of a drug?
The dose that is the most effective and has few side effects
Determined during trials involving patients suffering from the illness.
How are patients grouped in clinical trials?
Patients are randomly assigned to two groups: one receives the new drug and the other receives a placebo
This helps to measure the actual effect of the drug.
What is a placebo?
A substance that resembles the drug being tested but has no therapeutic effect
Used to assess the placebo effect in clinical trials.
What is the purpose of blind and double-blind trials?
To prevent bias by ensuring neither the patient nor the doctor knows who receives the drug or placebo
This helps in accurately analyzing results.
What is peer review?
The process where other scientists evaluate the validity and rigor of the drug testing work
Ensures that results are credible before publication.
True or False: The results of drug testing are published immediately after the trials.
False
Results are published only after peer review.
