Developing Drugs Flashcards
Infection and Response (18 cards)
What is tested in preclinical testing?
Drugs are tested on human cells and tissues in the lab
This is the initial phase before testing on live animals.
Why can’t human cells and tissues be used to test drugs affecting whole body systems?
Because it requires an intact circulatory system present in whole animals
Example: Testing a drug for blood pressure.
What is the next step in preclinical testing after lab tests?
Testing the drug on live animals
This tests efficacy, toxicity, and optimal dosage.
What does toxicity refer to in drug testing?
How harmful the drug is
Essential to determine safety before human trials.
What does optimal dosage mean?
The concentration that should be given and how often it should be given
Important for maximizing effectiveness and minimizing side effects.
What does British law state regarding new drug testing?
Any new drug must be tested on two different live mammals
This is a legal requirement to ensure safety.
What are the two perspectives on animal testing?
- Some think it’s cruel
- Others believe it’s necessary for safety
Debate exists on the ethics of animal testing.
What happens if a drug passes animal tests?
It is tested on human volunteers in a clinical trial
This is the next phase of drug development.
What is the purpose of testing the drug on healthy volunteers first?
To ensure it doesn’t have harmful side effects when the body is working normally
This step is crucial for assessing safety.
What is done with the dosage during the initial phase of human trials?
A very low dose is given and gradually increased
This helps to assess tolerance and side effects.
What is the optimum dose?
The dose of the drug that is the most effective and has few side effects
This is determined during trials on patients with the illness.
How are patients grouped in clinical trials?
Patients are randomly put into two groups: one receives the drug, the other a placebo
This method helps to assess the drug’s effectiveness.
What is a placebo?
A substance like the drug being tested but that doesn’t do anything
Used to measure the placebo effect.
What is the placebo effect?
When a patient expects treatment to work and feels better even though the treatment isn’t effective
Important to control in clinical trials.
What does it mean for clinical trials to be blind?
Patients do not know whether they’re receiving the drug or the placebo
Helps prevent bias in patient reporting.
What is double-blind in clinical trials?
Neither the patient nor the doctor knows who receives the drug or placebo until results are gathered
This further reduces bias in the study.
When are the results of drug testing published?
After they have been through peer review
Peer review helps validate the research.
What is peer review?
When other scientists check the work to ensure it is valid and rigorously conducted
This process helps prevent false claims.
