Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

L2 pharmacology > Drug development > Flashcards

Drug development Flashcards

1
Q

What are the stages of drug development? (4)

A
  • Basic research and target selection
  • Pre-clinical research
  • Clinical research (3 phases)
  • Regulatory review
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is pre-clinical research?

A

Animal testing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is clinical research?

A
  • Human testing
  • Split into 3 phases
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What is phase 1 of clinical research?

A

Testing on healthy human volunteers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is phase 2 of clinical research?

A

Testing on patients with the disease

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is phase 3 of clinical research?

A

Larger trial (1000+ patients) testing on patients with the disease

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is target selection?

A

Selection of ‘lead molecule’ by screening a series of molecules for their interaction with your chosen target (receptor/enzyme etc.) and identifying one that could be therapeutically useful

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What testing is done after the selection of a lead molecule? (2)

A
  • Exploratory toxicology
  • Exploratory safety
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is LD50?

A
  • The amount of the drug which kills 50% of the animals in the trial
  • Old method of animal testing
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

How is animal toxicology carried out?

A
  • Drug must be tested in a rodent (rat) and non-rodent (beagle)
  • Testing carried out in 3 dose groups
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What are the 3 dose groups tested in animal toxicology?

A
  • Low (no toxicology)
  • Intermediate
  • High (toxicology expected in target organ)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What parameters are looked at in animal toxicology? (4)

A
  • Haematology
  • Kidney and liver function
  • Coagulation
  • Large organ toxicity
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What are the goals of non-clinical safety evaluations? (7)

A
  • Identify on/off target toxicity
  • Reversibility
  • Relate toxicity to exposure
  • Define a max non-toxic dose and a min affective dose
  • Select the dose for human testing
  • Identify specific monitoring requirements
  • Identify potential undesirable effects on CV system/CNS/respiratory etc.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is determined in phase 1 clinical trials? (3)

A
  • Safety
  • Tolerance
  • Pharmacokinetics (how long the drug stays in the body etc.)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is determined in phase 2 clinical trials? (2)

A
  • Dose
  • Efficacy
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

How are biopharmaceuticals different from small molecule drugs? (2)

A
  • Small molecule drugs have low molecular weight and are chemically synthesised
  • Biopharmaceuticals (e.g. proteins, monoclonal antibodies) have more complex structures and are derived from living organisms
17
Q

How is animal toxicology different when testing biopharmaceuticals vs small molecule drugs? (4)

A
  • Need to be careful when selecting an animal model because biopharmaceuticals are humanised proteins which could likely cause an immune response if given to an animal
  • Sometimes non-human primates are used
  • Off-target toxicology uncommon
  • On-target toxicology can be massive
18
Q

What are ADA responses? (4)

A
  • Anti-Drug Antibody responses
  • Organisms being tested with biopharmaceuticals need to be monitored for the production of antibodies against the biologic
  • Could cause accelerated clearance, neutralise the activity, prolonged exposure etc.
  • Important pre-clinical evaluation for biologics
19
Q

What is the maximum dose defined as for biopharmaceuticals in preclinical studies?

A

10x the maximum that would be used in clinical trials (no point going past that point)

20
Q

What is the phase 1 dose defined as for biopharmaceuticals?

A

Smallest possible dose that is expected to cause a biological effect

21
Q

What immunotoxicology tests are done preclinically for biopharmaceuticals?

A

Determine the risk for a cytokine storm reaction before clinical testing

22
Q

What immunotherapies have been developed? (2)

A
  • Checkpoint inhibitors
  • CAR-T cell therapy
23
Q

What are checkpoint inhibitors?

A

Monoclonal antibodies which release a natural brake on the immune system to allow T cells to attack tumours

24
Q

What is CAR-T therapy?

A

Engineer a patient’s own immune cells to recognise their specific tumour

L2 pharmacology (9 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions