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Small Scale Flashcards

1
Q

The only legalised definition of personalised medicine is given in what act

A

US genomics and personalised medicine act 2008 S2

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2
Q

In the EU, what regulations are in place to control personalised medicines

A

Council regulation on advanced therapy MP
Amending council directive
Council regulation

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3
Q

How many genes have been identified for human P450 enzymes

A

57 💃

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4
Q

What specific p450 enzyme prevents 10% of the population from getting pain relief from codeine

A

CYP2D6

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5
Q

What CYP450 enzyme causes the toxicity of paracetamol

A

CYP3A4

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6
Q

Name the CYP450 that has been found to have genetic variants and metabolises warfarin

A

CYP2C9

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7
Q

Name 3 terms used to describe tests used to analyse/assess patients for disease

A

Companion diagnostics
Theranostics
Therapygenetics

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8
Q

Define special

A

A special is a non-licensed medicine manufactured to fulfill the prescribers requirements

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9
Q

What act does extemporaneous dispensing come under

A

Section 10 exemption of medicines act 1968

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10
Q

Which part in the human medicines regulation 2012 applies to unlicensed medicines

A

Part 10- exception to requirement for marketing authorisation

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11
Q

If a ‘special’ is manufactured in the UK manufacturers must hold what?

A

Manufacturers specials license and/or an investigative medicinal products (clinical trials) licence

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12
Q

Can manufacturers of specials advertise their products?

A

NO only their service

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13
Q

When supplying specials- the human medicines regulations 2012 requires you to keep a record of that supply for how long?

A

At least 5 years

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14
Q

What does TSE guideline stand for

A

Transmissible spongiform enchephalopathies

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15
Q

What does ICH in ICH Q10 stand for

A

International conference on harmonisation

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16
Q

What’s ICH Q8

A

Pharmaceutical development

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17
Q

What’s ICH Q9

A

Quality risk management

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18
Q

What does ICH Q10 link together

A

Many aspects of pharmaceutical preparation

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19
Q

The principles of GMP are stated where

A

In EU Directory 2003/94

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20
Q

Name 3 types of non spore forming bacteria

A

Staph
Strept
Micrococcus

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21
Q

Name two types of bacterial spores

A

Bacillus

Clostridium

22
Q

Define hazard

A

Is the potential to cause harm

23
Q

Define risk

A

Is the likelihood of harm

24
Q

To be declared as hazardous, a drug must meet one or more of the following criteria

A 
Carcinogenic
Teratogenic 
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity
25
Q

What type of gloves offer better protection

A

Nitrile or neoprene gloves

26
Q

What does CIVAS stand for

A

Central intravenous additive service (CIVAS) products

27
Q

What happens when vitamin A in a PN bag is exposed to sunlight

A

It’s broken down

28
Q

What is produced when the lipid emulsion in a PN bag is exposed to oxygen and sunlight

A

Formation of lipid peroxides- can be harmful

29
Q

When exposed to air, oxidation of amino acids occur in PN bags, what amino acid has degradation products that can cause cholestasis and possibly neurotoxicity

A

Tryptophan

30
Q

What catalyses the breakdown of vitamin C in PN

A

Copper, breakdown product precipitates with Ca2+

31
Q

What’s the breakdown product of vitamin C that precipitates with Ca2+ in a PN bag

A

Oxalic acid

32
Q

Name the 4 steps of vitamin C break down

A

Ascorbic acid
Degydro-ascorbic acid
Diketogluconic acid
Oxalic acid

33
Q

Which salt is more soluble: mono or dibasic

A

Mono

34
Q

Final pH of PN mixtures should be what

A

Above 5 and below 6 to reduce precipitation

35
Q

When making PN bag what do you add the macro-electrolytes to

A

The amino acids

36
Q

When making PN bag should you separate and dilute the calcium and phosphate components before mixing?

A

Yes

37
Q

When do you add the lipid to the PN bag

A

Last

38
Q

Where do you add vitamins to when making PN bag

A

Add vitamins to lipid

39
Q

When making PN bag should you separate trace elements and vitamins

A

YES

40
Q

Droplets of fat for a PN bag are designed to be what size

A

Equivalent to chylomicrons (0.2u)

41
Q

What are the three stages of lipid instability

A

Aggregation
Creaming
Cracking

42
Q

What are biologicals

A

They are medicinal products which are produced by or derived from a living system

43
Q

What is gene therapy

A

the deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes

44
Q

What does ADC stand for?

A

Antibody-drug conjugate.

45
Q

Name three favoured classes of ADCs

A

Maytansinoids
Auristatins
Calichaemicins

46
Q

How do maytansinoids work

A

Inhibitors of tubulin reorganisation- prevent tubulin polymerisation and depolymerisation

47
Q

Can unconjugated maytansinoids be used in ADCs

A

No due to their high toxicity

48
Q

What is adcetris?

A

An anti-CD30 mAb conjugated to mono-methylauristatin E by valine-cutrulline dipeptide linker

49
Q

What is kadcyla

A

An anti-HER2 antibody conjugated to DM-1 payloads by non-cleavable thioether linkers

50
Q

What receptors serve to limit T cell activation

A

CTLA-4

PD-1

51
Q

Name two immune ‘check points’ expressed on cancer cells

A

B7

PDL-1

52
Q

What is ipilimumab?

A

Anti-CTLA4 antibody used to treat late stage melanoma

Small Scale (1 decks)

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