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Biology (paper 1)
Biology-topic 3
Fighting disease-developing drugs
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Cards (42)
What is the first stage in drug testing?
Preclinical testing
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Why can't
human cells
and
tissues
be used to test drugs that affect whole body systems?
Because they do not represent an
intact circulatory system
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What is tested during
preclinical testing
on live animals?
Efficacy,
toxicity
, and best
dosage
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What does the
law
in
Britain
require regarding
drug testing
on animals?
Any new drug must be tested on
two
different live mammals
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What are the arguments for and against
animal testing
in
drug development
?
Some believe it's cruel, while others think it's the safest method
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What happens if a drug passes
animal testing
?
It is tested on human volunteers in a
clinical trial
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Why are healthy volunteers used in the initial phase of
clinical trials
?
To ensure there are no
harmful
side effects when the body is
normal
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What is the purpose of gradually increasing the
drug dose
during trials?
To find the
optimum dose
with the most effect and fewest
side effects
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How are patients grouped in
clinical trials
?
One group receives the drug, and the other receives a
placebo
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What is the significance of using a
placebo
in drug trials?
It allows for the assessment of the
drug's
actual effect versus the placebo effect
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What does it mean for a
clinical trial
to be
blind
or
double-blind
?
Patients or doctors do not know who receives the drug or
placebo
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What must happen to the results of
drug testing
before they are published?
They must go through
peer review
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What is
peer review
in the context of drug testing?
It is when other
scientists
check the validity and correctness of the work
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What are the three main stages in drug testing?
Preclinical
testing on
human cells
and tissues
Testing on
live animals
Clinical trials
on human volunteers
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What are the key aspects tested during
preclinical testing
on live animals?
Efficacy
: Does the drug work?
Toxicity
: How harmful is it?
Best
dosage
: What is the optimal concentration and frequency?
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What is the process of
clinical trials
after
preclinical testing
?
Test on healthy volunteers
Gradually increase dosage
Test on patients with the illness
Randomly assign patients to drug or
placebo
groups
Conduct
blind
or
double-blind
trials
Results undergo
peer review
before publication
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What is the purpose of trialling new drugs?
To check they're safe and
effective
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What are the three main aspects tested in drug trials?
Toxicity
— how harmful the drug is
Efficacy
— whether the drug works
Dosage
— the concentration and frequency of administration
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What does
toxicity
refer to in
drug
testing?
How harmful the drug is
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What does
efficacy
refer to in drug testing?
Whether the drug works and produces the
desired effect
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What does
dosage
refer to in drug testing?
The
concentration
that should be given and how often
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What are the stages of
preclinical testing
?
Tests on
human cells
and tissues
Tests on
live animals
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What is a
double-blind
clinical trial
?
Neither the participants nor the researchers know who receives the drug or
placebo
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What are
placebos
in drug testing?
Substances that are like the drug being
tested
but don't do anything
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What is the process of
clinical trials
?
Tests on healthy volunteers
Gradual increase of
dosage
from a very low initial dose
Tests on ill patients
Finding the
optimum dose
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What is the purpose of
peer review
in drug testing?
To evaluate the
validity
and
reliability
of the research
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How do
clinical trials
ensure the safety and efficacy of a drug?
Use of
placebos
to compare effects
Gradual
dosage
increase to monitor reactions
Testing on both healthy
volunteers
and ill patients
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What is the purpose of testing drugs in
clinical trials
?
To determine how the drug works and its
effects
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What does
toxicity
refer to in
drug
testing?
Toxicity refers to how harmful the drug is
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What does dosage indicate in
drug
testing?
Dosage
indicates how much and how often the drug should be given
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What is the
significance
of testing on humans and tissues?
It allows for cheap testing of various
substances
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What is a limitation of testing on humans and tissues?
It does not show how the drug would affect an entire
organism
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What is
Stage 2
of
drug testing
?
Testing on small animals like
mice
or
rabbits
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What does
Stage 2
testing provide information about?
It provides a good idea of the drug's
efficacy
and
toxicity
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What occurs in
Stage 3
of drug testing?
The drug is given to
healthy volunteers
at low doses
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How is the
dosage
adjusted during
Stage 3
testing?
The dosage is gradually increased to find the maximum dose without
side effects
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What is the purpose of using a
placebo
in
drug trials
?
To ensure that the test results are
valid
by comparing it to the real drug
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What is the
method
of
minimizing
bias
in drug trials?
Using a
blind trial
where
participants
do not know which drug they are receiving
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What is a
double-blind trial
?
Neither the doctor nor the
volunteer
knows which drug they have
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Why are results from
drug trials
analyzed and
peer-reviewed
?
To prevent false results and ensure
scientific validity
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