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Use and Abuse > Drug Testing > Flashcards

Drug Testing Flashcards

1
Q

What is the purpose of animal testing?

A

It helps us understand drugs and diseases and develop new drugs and surgical techniques.
(Lecture 9, Slide 5)

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2
Q

What 3 things can animal testing not be used for?

A

Tobacco products (banned in 1997)
Cosmetics or cosmetic ingredients (banned in 1998)
Household products (banned in 2015)
(Lecture 9, Slide 5)

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3
Q

Why do we use animals for testing as opposed to humans?

A

New drugs need to be assessed for effectiveness, dosage and toxicity and to ensure it will be therapeutically beneficial and not harmful during drug development and humans cannot be used for this.
(Lecture 9, Slide 6)

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4
Q

What is the pro of animal testing?

A

Many animals are similar to humans in terms of anatomy, physiology and biochemistry meaning that effects of drugs in animals generally predict effects in humans.
(Lecture 9, Slide 7)

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5
Q

What are the 3 cons of animal testing?

A

Not all physiological systems in animals are identical to humans and this depends on the species and system.
Drug metabolism may be different.
Major legal and ethical problems
(Lecture 9, Slide 7)

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6
Q

What animal is used for the majority of animal testing?

A

Mice
(Lecture 9, Slide 10)

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7
Q

What are 3 alternatives to animal testing?

A

Tissue from dead animals
Cells in culture
Biochemical assays
Receptor binding studies
Use of humans / human tissue
Use of lower species (such as insects, bacteria, fungi or yeast)
(Lecture 9, Slide 14)

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8
Q

What are the 2 pros of using tissues from dead animals?

A

It’s not a regulated procedure - as long as death is humane.
Multiple tissues / organs can be taken from a single animal.
(Lecture 9, Slide 15)

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9
Q

What are the 2 cons of using tissues from dead animals?

A

It only tells you about responses and behaviours of individual tissues or organs in isolation.
Although it limits suffering, it doesn’t limit usage of animals.
(Lecture 9, Slide 15)

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10
Q

What are the 3 pros of using cells in culture?

A

It is repeatable - immortalised cells live forever
Low animal usage
It is economic as it can be repeated
(Lecture 9, Slide 16)

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11
Q

What are the 2 cons of using cells in culture?

A

May not be physiological as cells may be transformed and lose their parent characteristics.
Only tells you about cellular responses.
(Lecture 9, Slide 16)

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12
Q

What is a biochemical assay?

A

“Test-tube” assays of physiological / biochemical responses made from proteins / enzymes derived from animal tissue.
(Lecture 9, Slide 18)

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13
Q

What can biochemical assays be used to test?

A

Drugs that inhibit specific enzymes.
(Lecture 9, Slide 18)

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14
Q

What are the 2 cons of using biochemical assays?

A

Only tells you about simple drug-enzyme interactions.
Reaction material still needs to be taken from animals.
(Lecture 9, Slide 21)

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15
Q

How are receptor binding studies designed?

A

An immortalised cells is transfect with DNA for receptor, making cells express the receptor on the membrane.
(Lecture 9, Slide 23)

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16
Q

Why are receptor binding studies used?

A

To determine the ability of potential drugs to bind to the receptor.
(Lecture 9, Slide 24)

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17
Q

What are the 3 cons of using receptor studies?

A

Only tells you about simple drug receptor interactions.
Immortalisation can change cell characteristics
Expression can change receptor characteristics meaning it may not represent what would happen in a full body.
(Lecture 9, Slide 24)

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18
Q

What is the benefit of using humans / human tissue for drug testing?

A

It gives an accurate prediction of responses in humans.
(Lecture 9, Slide 25)

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19
Q

What are the 3 cons of using humans / human tissue for drug testing?

A

Short supply
Safety concerns of both the participant and researcher
Massive ethical considerations
(Lecture 9, Slide 25)

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20
Q

What are the 2 pros of using lower species for drug testing?

A

Relatively economic and easily repeatable.
(Lecture 9, Slide 26)

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21
Q

What are the 2 cons of using lower species for drug testing?

A

Unrelated to humans
Still using animals
(Lecture 9, Slide 26)

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22
Q

What year was the first legislation for animal testing introduced?

A

1876 (Cruelty to Animals Act)
(Lecture 9, Slide 29)

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23
Q

Who manages the regulation of animal testing?

A

The Home Office (Animals in Science Regulations Unit)
(Lecture 9, Slide 30)

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24
Q

What 3 groups animals are not permitted to be tested on?

A

Great apes (banned in 1986)
Dogs, cats, monkeys or horses where other animals will suffice
Any animal where there is a non-animal method alternative available.
(Lecture 9, Slide 31)

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25
Q

What counts as a regulated procedure?

A

Anything involving dogs, cats, monkeys and horses
Any vivisection (surgery or procedure on a live animal)
(Lecture 9, Slide 32)

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26
Q

What licence is any individual who conducts an experiment on animals must have by law?

A

A personal investigators licence
(Lecture 9, Slide 33)

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27
Q

What licence does every experiment involving animals required to have by law?

A

A project licence
(Lecture 9, Slide 33)

28
Q

What license does every institution who conducts any experiments required to have by law?

A

An establishment licence
(Lecture 9, Slide 33)

29
Q

Who grants the 3 licences required for animal testing?

A

The government
(Lecture 9, Slide 33)

30
Q

What must researchers have to be granted a licence to conduct experiments on animals?

A

The necessary training, skills and experience.
(Lecture 9, Slide 35)

31
Q

What must a premises have to be granted a licence to have experiments on animals be conducted in it?

A

The necessary facilities to look after animals.
(Lecture 9, Slide 35)

32
Q

What is the harm-benefit analysis of animal testing?

A

Potential results must be important enough to justify animal use to be granted a licence.
(Lecture 9, Slide 35)

33
Q

What is the only scenario in which protected species can be used for animal experiments?

A

When no other species are suitable.
(Lecture 9, Slide 35)

34
Q

What is the only scenario in which animal experiments are used?

A

When the research cannot be done using non-animal methods.
(Lecture 9, Slide 35)

35
Q

How many animals are used in animal experiments?

A

The minimum required to get meaningful results.
(Lecture 9, Slide 35)

36
Q

What are 3 things defined in a project licence?

A

Defines aims, background and duration of the work, justifies the use of animals and describes procedures used.
(Lecture 9, Slide 36)

37
Q

What are Personal Investigator Licence holders required to undertake?

A

A home office accredited personal investigator licence course. (~ 30 - 40 hrs)
(Lecture 9, Slide 38)

38
Q

What does a personal investigator licence show?

A

That the holder has had appropriate training and it defines the techniques the holder may use.
(Lecture 9, Slide 38)

39
Q

What are 3 ways that animal experiments are monitored?

A

Home office inspector visits, a named veterinary surgeon for each premises and annual returns of animal use for each licensed project.
(Lecture 9, Slide 39)

40
Q

What is the first phase of drug testing in humans?

A

Drug is tested on healthy volunteers
(Lecture 10, Slide 4)

41
Q

What is the second phase of drug testing in humans?

A

Drug tested on patients with disease
(Lecture 10, Slide 4)

42
Q

What is the third phase of drug testing in humans?

A

Randomised control trials
(Lecture 10, Slide 4)

43
Q

What is the fourth phase of drug testing in humans?

A

Post-marketing surveillance.
(Lecture 10, Slide 4)

44
Q

What 3 things are found in phase 1 of human testing?

A

To find a safe dose, determine the ADME of the drug (Absorption ,Distribution ,Metabolism, Excretion) and how it’s effected by several factors.
(Lecture 10, Slide 8)

45
Q

What types of volunteers are involved in phase one of drug testing in humans?

A

Paid volunteers, who are young adult males.
(Lecture 10, Slide 8)

46
Q

Why are only male volunteers used in phase 1 of drug testing in humans?

A

Due to concerns of the effect of the drug on female fertility
(Lecture 10, Slide 8)

47
Q

What are the 2 ethical concerns of phase 1 of drug testing in humans?

A

Giving potentially dangerous drugs to healthy people and whether participants can accurately assess the risk.
(Lecture 10, Slide 9)

48
Q

What are the 3 problems of phase 1?

A

Not enough participants to detect rare issues,
Prone to selection bias as they aren’t randomised
Doesn’t represent the entire population, only specific individuals.
(Lecture 10, Slide 11)

49
Q

What 3 things are researchers trying to find out in phase 2 of human testing?

A

What is the safe/ effective dose in patients with the disease?
Does the drug have any unintended effects in patients with the disease?
What is the ADME profile in patients with the disease?
(Lecture 10, Slide 13)

50
Q

What 2 things make it difficult to assess the therapeutic effects of the drug in stage 2 of drug testing in humans?

A

Due to the placebo effect and participants may improve spontaneously (correlation does not mean causation)
(Lecture 10, Slide 15)

51
Q

What participants are involved in phase 3 of drug testing in humans?

A

They have specific selected criteria (inclusion conditions) and don’t have other specifically selected criteria (exclusion conditions)
(Lecture 10, Slide 20)

52
Q

What is the study population divided into in phase 3 of drug testing in humans?

A

Into 2 or more treatment (intervention) populations.
(Lecture 10, Slide 20)

53
Q

What 2 things are researchers trying to find out in phase 3 of drug testing in humans?

A

Is the drug better compared to an existing drug or placebo?

Are there less side effects compared to an existing drug?
(Lecture 10, Slide 21)

54
Q

How are groups matched to ensure changes are due to the drug in stage 3 of drug testing in humans?

A

Groups are matched as closely as possible in all non treatment factors such as;
Age
Gender
Disease severity
Smokers / Non smokers
Socio-economic group
(Lecture 10, Slide 25)

55
Q

How are patient and investigator bias eliminated from phase 3 of drug testing in humans?

A

By using a double blind trial.
(Lecture 10, Slides 27 and 28)

56
Q

What is a double blind trial?

A

Patients don’t know which treatment they are receiving and investigators do not know what drug they are giving.
(Lecture 10, Slide 28)

57
Q

What are 2 problems in phase 3 trials of drug testing in humans?

A

Poor randomisation and breach of blinding.
(Lecture 10, Slide 29)

58
Q

What can cause breach of blinding in phase 3 trials of human drug testing?

A

Quality of placebo presentation - patients might be able to tell which treatment is which.

Participant detecting a clear benefit / lack of benefit of treatment - patients can work out which treatment group they are in.
(Lecture 10, Slide 29)

59
Q

What are the 3 ethical concerns of phase 3 trials of drug treatment in humans?

A

Is placebo use justified in sick patients?

What should be used for comparison?

If results are really good / really bad, should the trial be stopped early?
(Lecture 10, Slide 30)

60
Q

When is phase 4 of drug testing in humans conducted?

A

After the medicine has a licence for use
(Lecture 10, Slide 32)

61
Q

What 4 things are looked for in phase 4 of drug testing in humans?

A

Unusual adverse effects
Drug interactions
Why some patients don’t respond to the drug
Modifications of underlying disease processes
(Lecture 10, Slide 32)

62
Q

What can phase 4 of drug testing in humans lead to?

A

Drug withdrawal from the market
(Lecture 10, Slide 32)

63
Q

Who are the participants in phase 4 of drug testing in humans?

A

Anyone who has been prescribed the medicine (this is found using national healthcare records)
(Lecture 10, Slide 33)

64
Q

Why does phase 4 detect more rare or chronic adverse effects than phase 3 trials in drug testing in humans?

A

As phase 3 studies only use a couple hundred patients over a few months and phase 4 uses a lot more for a longer period of time
(Lecture 10, Slide 34)

65
Q

Who conducts monitoring of newly licenced medicines?

A

Medicines and Healthcare products Regulatory Agency (MHRA).
(Lecture 10, Slide 34)

66
Q

What are 3 reasons some patients don’t respond to the drug in phase 4 of drug testing in humans?

A

Different comorbidities (when a person has more than 1 disease or condition)
Different medication combinations
Greater range of genetic diversities.
(Lecture 10, Slide 36)

67
Q

What additional consequences can phase 4 of drug testing in humans discover?

A

Consequences of long-term treatment with the drug (may be beneficial or detrimental)
(Lecture 10, Slide 37)

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