Small Scale

Question 1

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

Answer 1

US genomics and personalised medicine act 2008 S2

Question 2

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

Answer 2

Council regulation on advanced therapy MP
Amending council directive
Council regulation

Question 3

How many genes have been identified for human P450 enzymes

Answer 3

57 💃

Question 4

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

Answer 4

CYP2D6

Question 5

What CYP450 enzyme causes the toxicity of paracetamol

Answer 5

CYP3A4

Question 6

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

Answer 6

CYP2C9

Question 7

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

Answer 7

Companion diagnostics
Theranostics
Therapygenetics

Question 8

Define special

Answer 8

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

Question 9

What act does extemporaneous dispensing come under

Answer 9

Section 10 exemption of medicines act 1968

Question 10

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

Answer 10

Part 10- exception to requirement for marketing authorisation

Question 11

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

Answer 11

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

Question 12

Can manufacturers of specials advertise their products?

Answer 12

NO only their service

Question 13

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

Answer 13

At least 5 years

Question 14

What does TSE guideline stand for

Answer 14

Transmissible spongiform enchephalopathies

Question 15

What does ICH in ICH Q10 stand for

Answer 15

International conference on harmonisation

Question 16

What’s ICH Q8

Answer 16

Pharmaceutical development

Question 17

What’s ICH Q9

Answer 17

Quality risk management

Question 18

What does ICH Q10 link together

Answer 18

Many aspects of pharmaceutical preparation

Question 19

The principles of GMP are stated where

Answer 19

In EU Directory 2003/94

Question 20

Name 3 types of non spore forming bacteria

Answer 20

Staph
Strept
Micrococcus

Question 21

Name two types of bacterial spores

Answer 21

Bacillus

Clostridium

Question 22

Define hazard

Answer 22

Is the potential to cause harm

Question 23

Define risk

Answer 23

Is the likelihood of harm

Question 24

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

Answer 24

Carcinogenic
Teratogenic 
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity

Question 25

What type of gloves offer better protection

Answer 25

Nitrile or neoprene gloves

Question 26

What does CIVAS stand for

Answer 26

Central intravenous additive service (CIVAS) products

Question 27

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

Answer 27

It's broken down

Question 28

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

Answer 28

Formation of lipid peroxides- can be harmful

Question 29

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

Answer 29

Tryptophan

Question 30

What catalyses the breakdown of vitamin C in PN

Answer 30

Copper, breakdown product precipitates with Ca2+

Question 31

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

Answer 31

Oxalic acid

Question 32

Name the 4 steps of vitamin C break down

Answer 32

Ascorbic acid Degydro-ascorbic acid Diketogluconic acid Oxalic acid

Question 33

Which salt is more soluble: mono or dibasic

Answer 33

Mono

Question 34

Final pH of PN mixtures should be what

Answer 34

Above 5 and below 6 to reduce precipitation

Question 35

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

Answer 35

The amino acids

Question 36

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

Answer 36

Yes

Question 37

When do you add the lipid to the PN bag

Answer 37

Last

Question 38

Where do you add vitamins to when making PN bag

Answer 38

Add vitamins to lipid

Question 39

When making PN bag should you separate trace elements and vitamins

Answer 39

YES

Question 40

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

Answer 40

Equivalent to chylomicrons (0.2u)

Question 41

What are the three stages of lipid instability

Answer 41

Aggregation Creaming Cracking

Question 42

What are biologicals

Answer 42

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

Question 43

What is gene therapy

Answer 43

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

Question 44

What does ADC stand for?

Answer 44

Antibody-drug conjugate.

Question 45

Name three favoured classes of ADCs

Answer 45

Maytansinoids Auristatins Calichaemicins

Question 46

How do maytansinoids work

Answer 46

Inhibitors of tubulin reorganisation- prevent tubulin polymerisation and depolymerisation

Question 47

Can unconjugated maytansinoids be used in ADCs

Answer 47

No due to their high toxicity

Question 48

What is adcetris?

Answer 48

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

Question 49

What is kadcyla

Answer 49

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

Question 50

What receptors serve to limit T cell activation

Answer 50

CTLA-4 | PD-1

Question 51

Name two immune 'check points' expressed on cancer cells

Answer 51

B7 | PDL-1

Question 52

What is ipilimumab?

Answer 52

Anti-CTLA4 antibody used to treat late stage melanoma