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Pharmacology > Drug Discovery > Flashcards

Drug Discovery Flashcards

1
Q

Where do compounds come from?

A

Bacteria, animals, fungi, genetic engineering and synthetic compounds.

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2
Q

Years of Drug discovery and development

A

2-10 years

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3
Q

Years of Preclinical research and development

A

3-6 years

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4
Q

Clinical trial years

A

6-7 years

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5
Q

FDA reviews NDA years

A

1-2 years

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6
Q

Initial synthesis of substance

A

Preclinical research and development

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7
Q

Laboratory studies and animal testing

A

Preclinical research and development

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8
Q

Institutional review boards

A

Preclinical research and development

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9
Q

Research and development (all trials approved by IRB)

A

Clinical trial

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10
Q

Clinical trial phase where there is testing in healthy subjects

A

Phase 1

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11
Q

Clinical trial phase where there is testing in healthy individuals with the diseases.

A

Phase 2

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12
Q

Clinical trial phase where larger scale testing in individuals with the disease is done.

A

Phase 3

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13
Q

FDA expects review data

A

FDA reviews NDA

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14
Q

NDA means

A

New drug application

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15
Q

Company addresses FDA concerns

A

FDA reviews NDA

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16
Q

Advisory hearing may be called

A

FDA reviews NDA

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17
Q

Drug appears on the market

A

Manufacturing

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18
Q

Postmarket surveillance

A

Manufacturing

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19
Q

Follow-up studies and inspections

A

Manufacturing

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20
Q

FDA means

A

Food Drug Administration

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21
Q

Determine what phase of clinical testing.

Is it safe, pharmacokinetics?
20-100 subjects

A

Phase 1

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22
Q

Determine what phase of clinical testing.

Does it work in patients?
100-200 patients

A

Phase 2

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23
Q

Determine what phase of clinical testing.

Does it work double blind?
1000-6000 patients

A

Phase 3

24
Q

Usually done on animals to determine the drug is safe enough for human testing

A

Preclinical trial

25
Q

Preclinical trial where research is done in lab dish or test tube

A

In vitro

26
Q

Preclinical trial where research is done in living organism.

A

In vivo

27
Q

Ability of drug to act against pathogen/disease

A

Efficacy

28
Q

Factors to be identified include mechanism of action, efficacy, safety, followed by Investigational New Drug

A

Preclinical trial

29
Q

Able to disturb the growth and development of an embryo or fetus

A

Teratogenic

30
Q

What phase?

Duration: months
type of studies: unblinded and uncontrolled

A

Phase 1

31
Q

What phase?
Factors to be identified: Safety and tolerability, Pharmacokinetics

A

Phase 1

32
Q

True or false. Volunteers in phase 1 are usually healthy men than women.

A

True

33
Q

A phase after IND to evaluate evaluate safety and efficacy

A

Phase 1

34
Q

IND means

A

Investigational New Drug

35
Q

What phase?

Duration: Months-Years
Type of studies: may be controlled (compare drug with Placebo or another standard drug)

A

Phase 2

36
Q

Phase to evaluate safety and efficacy

A

Phase 2

37
Q

What phase?
Large sample size
Factors to be identified include efficacy and dose selection

A

Phase 2

38
Q

Phase where participants are monitored very closely. Performed at hospitals, clinics and doctors offices.

A

Phase 2

39
Q

What phase?
Duration: Years
Larger sample size

A

Phase 3

40
Q

What phase?
Type of studies is randomized and controlled.

A

Phase 3

41
Q

Phase where we evaluate effectiveness and risk-benefit ratio

A

Phase 3

42
Q

What phase?
Factors to be identified include definitive evidence for efficacy and safety followed by NDA

A

Phase 3

43
Q

Phase of post marketing surveillance, monitor long term effects and effectiveness

A

Phase 4

44
Q

What phase?
Diverse population with target disease & new age groups, gender

A

Phase 4

45
Q

What phase?
Type of studies expended safety comparison

A

Phase 4

46
Q

Phase where factors to be identified include epidemiological data, efficacy and safety within large diverse populations, and pharmacoeconomics

A

Phase 4

47
Q

The comparison of value of one pharmaceutical drug

A

Pharmaeconomics

48
Q

Phase where they are voluntarily conducted by pharmaceutical companies

A

Phase 4

49
Q

3 stages of drug discovery and safety

A

Stage 1: Drug discovery
Stage 2: Pre-clinical development
Stage 3: Clinical development

50
Q

Stages Compounds

A

Stage 1: 10,000 compounds
Stage 2: 250
Stage 3: 5

51
Q

Determine what phase:

Larger scale safety and effectiveness
Effect on body
Long term safety
Effectiveness in treating diseases
Safety in humans

A

3,0,4,2,1

52
Q

The name by which a pharmaceutical company identifies its product

A

Brand name

53
Q

True or false. Brand name has capitalized first letter.

A

True

54
Q

Copyright and used exclusively by that company

A

Brand name

55
Q

___ since owned by company

A

Propriety or Brand name

56
Q

Often showed on labels and references with the symbol R encircled after the name (for “registered” trademark)

A

Brand name

Pharmacology (4 decks)

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