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drug discovery > lecture 8 > Flashcards

lecture 8 Flashcards

1
Q
A
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2
Q

what’s involved in preclinical testing

A

lab testing
animal short + long term testing

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3
Q

what is included in clinical trials

A

phase 0/1
phase 2
phase 3

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4
Q

what is included in post marketing surveillance

A

phase 4

it’s basically just a different name for if

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5
Q

whqt must be done between preclinical and clinical studies

A

IND submission
investigational new drug application

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6
Q

what must be done between phase 2 and post marketing surveillance

A

NDA submission ( new drug application)

regulatory approval

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7
Q

what is an ind

A

investigational new drug

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8
Q

how many types of IND are there

A

3

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9
Q

what are the 3 types of IND

A
  • investigator IND
  • emergency use IND
  • treatment IND
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10
Q

what is an investigator IND

A
  • application submitted by the physician who initiated and conducted the investigation.
  • can be submitted to propose the idea of studying an unapproved drug or further studying an approved product (new population etc)
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11
Q

what is an emergency use IND

A

it allows the FDA to authorise the use of an experimental drug in an emergency situation where this is no time to submit a normal investigator IND.

happened for ebola

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12
Q

what is a treatment IND

A

submitted for experimental drugs showing promise in clinical testing for serious// life threatening conditions while the final clinical work is conducted + FDA review takes place

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13
Q

what are the 2 types of IND

A

research (non commercial)
commercial

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14
Q

what 3 things must an IND contain

A
  • animal pharmacology + toxicology studies
  • manufacturing info
  • clinical protocols and investigator info
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15
Q

why is animal pharmacology and toxicology studies needed in an IND

A
  • it’s preclinical data that shows whether the product is safe for clinical trials
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16
Q

what is manufacturing information in IND

A
  • info about the composition, manufacturer, stability + controls used for manufacturing the drug substance + product.

consistent batches of drugs

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17
Q

what are clinical protocols and investigator info in IND

A
  • detailed protocols that show if initial phase trials would expose subjects to unnecessary risks
  • info about the physicians/investigators qualifications
  • commitments to obtain informed consent from the research subjects
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18
Q

what are clinical trials

A

they’re research that studies new tests + treatments + evaluated their effects on human health

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19
Q

in clinical trials,, what do ppl volunteer to test

A
  • cells
  • drugs
  • biological products
  • medical devices
  • surgical procedures
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20
Q

before clinical trials occur,, what must be done,,aka what must be done for them to occur

A

it must be designed, reviewed, completed + approved before.

u must have planned it ages in advance with all the info needed

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21
Q

what’s the range of ages that can take part in a clinical trial

A

ppl of all ages can take part

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22
Q

how many phases are there in clinical trials

A

4

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23
Q

what are the 4 phases in clinical trials

A
  • phase 0/1
  • phase 2
  • phase 3
  • phase 4
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24
Q

brief phase 0/1

A

test new drugs on a small group of ppl for the first time

evaluate a safe dosage range + identify side effects

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25
Q

brief phase 2

A

tests treatments that appear to be save from phase 1 but need more subjects to monitor for any adverse effects

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26
Q

brief phase 3

A

conducted on larger populations + in different regions// countries

this is the step before the drug is approved

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27
Q

brief phase 4

A

takes place after country approval

there is a need to test a wide population over a longer timeframe

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28
Q

what can clinical tests be used for doing

A

to see if:
treatment approach
prevention approach
behaviour approach
are safe + effective

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29
Q

types of clinical trials

A

epidemiology
behavioural
health services
clinical trials

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30
Q

epidemiology clinical trials

A

understand disease by studying patterns, causes, effects of health + disease in specific groups

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31
Q

behavioural clinical trials

A

understanding human behaviour + how it relates to health + disease

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32
Q

health service clinical trials

A

how ppl access health care providers + health services.

the cost of service + the results of this care

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33
Q

clinical trial clinical trials

A

evaluate the effects of intervention on health outcomes

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34
Q

why is the first phase called phase 0/1

A

bc it’s hard to discern between them

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35
Q

what the goal of phase 0/1

A

to see if the drug behaves in the same way researchers expected it to based on their lab studies

36
Q

how many ppl are involved in phase 0

A

less than 15

37
Q

what type of dose is given to phase 0

A

very small dose so side effects are low
no therapeutic effect
no drug safety or tolerance being studied

38
Q

what info is taken from phase 0

A

drugs engagement with the target
drug pharmacokinetics
MOA
drug pharmacodynamics

39
Q

what happens if in phase 0,, the drug does not perform the way researchers expected based on preclinical studies

A

they must return back to preclinical trials then decide on whether they should continue clinical trials or not.

40
Q

are healthy patients always tested in phase 1

A

no,, sometimes,, in oncology,, actual patients can also take part

41
Q

how many participants are there in phase 1

A

20-100 ppl
healthy volunteers

42
Q

ages of participation in phase 1 clinical trials

A

18-55 year olds

43
Q

what is measured in phase 1

A

tolerability
the best dosage form
duration of drug effectiveness
analysis of drug metabolites

44
Q

phase 1 tolerability meaning

A

finding the correct dose that doesn’t lead to evident side effects

45
Q

phase 1: best dosage administration form

A

oral
intravenous
etc

46
Q

what is phase 2 about

A

analysing the therapeutic efficacy in a particular patient population to find if the drug should continue to phase 3, finding the correct dose + treatment regime

47
Q

in phase 2 what must the participants have

A

they must have the condition of interest

48
Q

how many patients are chosen for phase 2 clinical trials

A

100-300 patients

49
Q

what is important about the chosen participants for phase 2

A

there is a strict inclusion/exclusion criteria

in pree for them to be homogenous

50
Q

what does homogeneous mean

A

all the same

all have the same type of smt

51
Q

phase 2 can be split into what

A

phase 2a and 2b

52
Q

how long is phase 2a

A

1 year

53
Q

what does phase 2a focus on

A

dosing requirements

54
Q

what happens in phase 2a

A

there’s a small number of patients that are administered the drug in diff quantities to evaluate if there is a dose response relationship

55
Q

what is the point of phase 2b

A

to test the efficacy of the drug in terms of how successful it is in treating/preventing/diagnosing the disease

56
Q

what is a limitation of phase 2 clinical trials

A

the fact that there is no control group,, aka there is no way in comparing the placebo and non placebo groups.

cannot see the effect of the drug being analysed

57
Q

phase 2:: two armed study

A

either drug or placebo

50 get the drug,, then they undergo interim analysis to check if dose is okay,, then they give the dose to 50 others. if the 50 have bad reactions,, clinical trials are cancelled

58
Q

if u have a good phase 2 trial does that mean phase 3 will also be good

A

no!!

59
Q

why doesn’t a good phase 2 trial correlate to a good phase 3 trial

A

bc phase 2 was trialed in a homogeneous group of ppl.

phase 3 is trialed on a heterogeneous group of ppl.

we cannot confirm that results can be replicated.

60
Q

what % of good phase 2 trials also lead to good phase 3 trials

A

roughly 60%

61
Q

what must the data found in phase 2 undergo in order for phase 3 to occur

A

it must go under thorough examination!! bc phase 3 is very expensive and money does not want to be wasted!!

62
Q

what’s special about phase 3 clinical trials

A

the most expensive!!!
money is given by a sponsor organisation,, normally a big pharmacy company

63
Q

sometimes the drug formulation, production and manufactures are too expensive for

A

clinical trials to occur

64
Q

continuing phase 3 trials possesses a large amount of

A

risk

65
Q

what is the goal of phase 3

A

confirm the efficacy and safety of the compound in a broad patient population

66
Q

how many ppl take place in phase 3

A

1000-3000 patients

67
Q

compounds normally undergo phase 3 in how many clinical trial sites

A

a lot!!!

there must be a lot of different clinical sites in a bunch of different countries

68
Q

what must also be present in phase 3 clinical trials

A

institutional review board (IRB)

69
Q

how long does phase 3 take

A

2.5 to 5 years

depends on the nature of disease and the patient population though

70
Q

components of a successful phase 3 trial

A
  • 2 studies that prove compound safety + efficacy
  • resulting info can be given to health care providers
  • end results can be extrapolated onto gen pop
  • more phase 3 trials can occur by the sponsor company in order to collect necessary data for market approval.
71
Q

why must there be 1000-3000 ppl in phase 3 trials

A
  • to provide a statistically significant result
  • bc it depends on the expected effect.
72
Q

in phase 3,, how many ppl should get a therapeutically relevant dose

A

more than 1500

73
Q

out of the 1500 getting a therapeutic dose in phase 3,, how many should be studied for a minimum of 6 months

A

300-600

74
Q

in phase 3: out of the 1500 ppl getting a therapeutic dose, how many should reach the year mark

A

100

75
Q

whqt should be decided for phase 3

A

if all the participants will be given the test therapy

76
Q

what cool thing can be done for phase 3

A

there can be a double blind trial

77
Q

what is the proper name for a phase 3 double blind trial

A

double blind randomised controlled trial

RCT

78
Q

in phase 3: double blind randomisation controlled trial,, what is meant by randomisation controlled

A

randomisation is used to put ppl in either the placebo or non placebo group

79
Q

why is phase 3 controlled by randomisation

A

in order to prevent unconscious + deliberate human influence when it comes to assigning groups

80
Q

why does the trial being double blind have importance

A

bc it ensures that treatment and analysis of outcomes is not influenced by prejudice.

prevents the researcher and patient from knowing who was administered the drug and who was given the placebo.

81
Q

what is a placebo pill

A

an inactive substance
no therapeutic effect
sugar pill!!

same taste, colour and characteristics as the actual drug but without the active principle//ingredients

82
Q

when can phase 4 occur

A

once the drug being studied has successfully completed 2 well controlled studies

83
Q

what’s another name for phase 4

A

post marketing surveillance studies

84
Q

in order for marketing approval to occur what must be complete

A

phase 2

post marketing surveillance studies

85
Q

objectives in post marketing surveillance studies aka phase 4

A
  • compare safety + efficacy of this compound vs competitors
  • identity low frequency adverse effects (aka u continue safety monitoring to better characterise the risks)
  • find potential drug - drug interactions
  • establish treatment guidelines for paediatric and geriatric population
  • determine the drugs real world efficacy
86
Q

difference between phase 3 and phase 4 in terms of ppl

A

ppl in phase 4 are more heterogeneous + larger groups of ppl

87
Q

what conditions in phase 4 (post marketing surveillance study) take the drug off the market

A
  • if there is already a more effective therapy present // available
  • if the drug doesn’t fulfil its anticipated goals in a more broader population of ppl

drug discovery (18 decks)

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