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Pharm & Ototoxicity > Quiz 1 (From lect. 2) > Flashcards

Quiz 1 (From lect. 2) Flashcards

1
Q

what is the doctrine of signatures

A

physical characteristics of plants and herbs indicate their potential therapeutic uses.
The idea is that plants and other natural substances have a “signature,” often related to their shape, color, texture, or smell, which signals their specific healing properties.

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2
Q

examples of the doctrine of signatures

A

Walnuts were good to cure ailments of the head because they had a perfect signature for the head
since they looked like the brain they are thought to help with cognitive abilities and brain related diseases

The holes in the leaves of Saint Johns Wort resemble pores of the skin and, therefore, can treat disease and wounds of the skin

beans are kidney shaped and they heal and help maintain kidney functions

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3
Q

In modern times, medicines are developed by chemical synthesis of compounds that have

A

biological activity

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4
Q

first successful drug used against malaria

A

quinine

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5
Q

what is quinine

A

some tree bark contains this
still used today as drug of choice against malaria
first specific drug used to treat an infectious disease

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6
Q

arsenic is a poison

A

true

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7
Q

vSynthesis of arsenicals

A

attached arsenic atom to a carbon atom to synthesize arsenicals
led to use of arsphenamine to treat syphilis

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8
Q

led to use of arsphenamine to treat syphilis

A

synthesis of arsenicals

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9
Q

what lead ot digitalis

A

use of purple foxglove aka digitalis purpurea
lead to isolation of digitalis
tea was made to treat edema of cardiac dropsy (congestive heart failure)

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10
Q

drug of choice for congestive heart failure

A

digitalis

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11
Q

drug is still isolated from plants digitalis lanata leaves rather than digitalis purpurea seeds) because it is too difficult and expensive to synthesize chemically

A

true
digitalis drug

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12
Q

the way we regulated morphine from poppy seeds was the same technique to regulate caffeine

A

true

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13
Q

isolation of morphine lead the way for isolation of

A

caffein, atropine & strychnine

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14
Q

growth of poppy plants for medicinal use in US is not regulated

A

false, highly regulated

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15
Q

narcotic, used for pain control

A

opium

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16
Q

what is the source of optium

A

poppy plant (Papavir somniferum)

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17
Q

how did isolation of morphine come about

A

The poppy plant, Papaver somniferum, that produces opium, a powerful narcotic whose derivatives include morphine, codeine, heroin, and oxycodone.

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18
Q

history of coffee goes at least as far back as the

A

13th century

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19
Q

original native population of coffee is thought to have come from_______specifically from ______

A

East Africa
Ethiopia

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20
Q

first cultivated by Arabs from the 14th century and onward

A

caffeine/coffee

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21
Q

caffeine process

A

extracted from the coffee plant, Coffea arabica
Caffeine works by stimulating the CNS, heart, and muscles
It relieves mental and physical fatigue and increases mental alertness

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22
Q

The entire plant is extremely poisonous

A

Atropa belladonna (Devil’s cherries)

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23
Q

devils cherries

A

Atropa belladonna (Devil’s cherries)

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24
Q

belladona means

A

an enchantress of exceeding loveliness

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25
Q

what aer the 2 alkaloid substances isolated from Atropa belladonna

A

atropin
scopolamine

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26
Q

what is atropin

A

dilates pupils
after fall to injury or sprained part belladona plasters are applied
ingestion in access is poisonous

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27
Q

what is scopolamine

A

(from japanese belladona) - motion sickness (transderm patch), sedative, truth serum & mydriasis (prolonged/excessive pupil dilation)

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28
Q

source of silicin

A

willow bark

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29
Q

how is salicylic acid metabolized

A

a source of slicin is willow bark
this metabolizes to salicylic acid in the body

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30
Q

chemical precursors to aspirin

A

salicin & salicylic acid

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31
Q

N-acetyl salicylic acid

A

aspirin

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32
Q

what is aspiring

A

popular analgesic/anti-inflammatory agent

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33
Q

how salicylic acid is formed

A

willow bark to get silicin
salicylic acid is converted to acetyl derivative (acetylsalicylic acid)

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34
Q

willow bark and salicylates increase risk of

A

bleeding
ulcers
tinnitus

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35
Q

father of modern pharmacology

A

john jacob abel

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36
Q

first hormone to be isolated

A

epinephrine (adrenaline)

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37
Q

where is epinephrine produced

A

Some neurons of the CNS
The chromaffin cells of the adrenal medulla from the amino acids, phenylalanine and tyrosine

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38
Q

what is in the epipens?

A

epinephrine

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39
Q

only NT used in motor division of somatic nervous system

A

acetylcholine

40
Q

what is acetylcholine

A

one of many NT in ANS
acts on CNS & PNS
has inhibitory effect in cardiac tissue to lower heart rate but is excitatory at neuromuscular junctions in skeletal muscle

41
Q

first effective treatments for pneumonia, meningitis, & other bacterial diseases

A

sulfanilamide

42
Q

discovery of sulfa

A

dye had no antibacterial effect butchanging its chemical makeup slightly allowed it to arrest infections in mice caused by streptococcal bacteria
found this active antibacterial portion of the dye naming it sulfanilamide (one of the first antibiotics)

43
Q

sulfa powder & tablets - carried during WWII to reduce mortality

A

true

44
Q

sulfa today

A

treat urinary tract infections

45
Q

sulfa drugs pre-dated clinical use of

A

penicillin

46
Q

what is prontosil

A

red dye

47
Q

penicillin discovery

A

discovered accidentally - mold know mas penicillium notatum inhibited growth of staphylococcus aureus (bacteria) in petri dish in a lab
was named penicillin
used in WWII to save lives and is why penicillin production occurred in the US

48
Q

past was a tea, derived from foxgloves, used for congestive heart failure

A

digitalis

49
Q

from tree bark, used against malaria

A

quinine

50
Q

arsenic atom attached to a carbon atom; arsphenamine to treat syphilis

A

syphillis

51
Q

poppy plant (Papavir somniferum) that produces poppies, opium is derived from poppy sap, morphine is then an active alkaloid found in opium
used to treat pain
isolation of morphine lead the way for isolation of caffein, atropine & strychnine

A

morphine

52
Q

extracted from the coffee plant, Coffea arabica
stimulates the CNS, heart, and muscles
relieves mental and physical fatigue and increases mental alertness

A

caffeine

53
Q

atropine (eye dilation) & scopoline (sedative & motion sickness - transderm patch)

A

Atropa belladonna (Devil’s Cherries)

54
Q

silicin from willow bark, turns into slicylic acid in body (both are precursors to aspirin/acetylsalicylic acid)

A

salicylic acid

55
Q

increase risk of bleeding, ulcers & tinnitus

A

willow bark & salicylates

56
Q

used for severe allergic reactions

A

epinephrine/adrenaline (1st discovered) (also NT)

57
Q

excites skeletal muscles & lowers heart rate (CNS & PNS & found in ANS)

A

acetylcholine (also NT)

58
Q

first antibiotic (sulfanilamide) that cured streptococcal bacterial infections (first effective treatment for pneumonia, meningitis & other bacterial diseases)
for urinary tract infections, reduced mortality in WWII & pre-dated clinical use of penicillin

A

sulfa

59
Q

found in mold (penicillium notatum) that stopped staphylococcus aureus bacteria
produced in US due to saving lives in WWII

A

penicillin

60
Q

what is the FDA

A

regulatory agency involved in regulation of drug development

61
Q

what is the purpose of the FDA

A

regulates food , drugs , cosmetics , OTC , supplements , drug dev, controlled substances (tobacco, sedatives , addictives , stimulants)

62
Q

why does the FDA have stronger rules

A

due to the Strep-Elixir - killed people by mixing drug molecule with antifreeze

63
Q

what is the FDA exemption law

A

allows FDA to permit off label use, and it was after the AIDS crisis
why we were able to make covid vaccine fast
permit pharmaceutical companies to broaden access to investigational products while they are still going through clinical trials

64
Q

what does the modern fda protect

A

public health by ensuring safety and effictiveness of meds, biological products, med devices, food, cosmetics, and radiation emitting products

65
Q

what does the modern fda advance

A

public health by accelerating innovations for more effective safer and affordable meds while providing public with accurate science-based info for better health

66
Q

approx ____ billion to produce new drug

A

$1-$2

67
Q

approx _____ years

A

12

68
Q

______ drugs make it to market

A

1/10

69
Q

what are the phases of drug development

A

discovery
development
clinical studies
post marketing surveillance

70
Q

what happens in discovery phase

A

Discover molecule & file patent

71
Q

what happens during development phase

A

short term toxicity w/ animals (LD50 & ED50 & MOS)
long term toxicity w/ specialized animals (reproductive & cancers), submit IND

72
Q

what is LD50

A

determine lethal dose - LD50 (50% out of total receiving drug dose are killed)

73
Q

what is ED50

A

determine effective dose - ED50 (50% out of total receiving drug dose causes an effect)

74
Q

What is the margin of safety

A

LD50 ÷ ED50
acceptable margin in drugs is >/= 2000

75
Q

LD50 = 10 mg
ED50 = 2 mg
what is mOS & what it means

A

MoS = 5
legal dose is only 5x the effective which is low margin of safety in humans

76
Q

what happens in phase 1

A

immediately after IND approval, 20-100 healthy individuals, non-blinded (participant & tester know) takes several months (shorter time), purpose is for safety, pharmocokinetics (what does the body do with the drug) & pharmacodynamics (how does it affect the body), tested for safety in volunteers

77
Q

waht happens in phase 2

A

up to several hundred diverse individuals with the disease, 1-4 yrs, purpose is for short-term effectiveness, safety, and dose ranging; double blind (random assignment, neither party knows)

78
Q

what happens in phase 3

A

several hundred to several thousand taking drugs, 1-4 years, toxicities here may not show until after marketing when millions take it long term, testing for safety, dosage, effectiveness & adverse effects

79
Q

submit NDA after conclusion of clinical trials (approx 8-9yrs after animal & human testing), if approved can sell

A

true

80
Q

what is phase 4

A

post marketing surveillance for adverse event monitoring forever
after FDA approval
monitored for remainder of life span
can be pulled off market or relabeled with new warnings and precautions

81
Q

wht is the right to try law

A

allows terminally ill patients to access experimental treatments that have passed Phase I of clinical trials but have not yet been approved by the Food and Drug Administration (FDA).
This legislation aims to give patients who have exhausted other treatment options the opportunity to try investigational drugs that could potentially help them, without waiting for the lengthy FDA approval process

82
Q

chemical drug name

A

determined by chemical structure; ex: acetylsalicylic acid

83
Q

generic drug name

A

not capatalized, FDA approved official name

84
Q

brand/trade name

A

trademarked

85
Q

What is ANDA?

A

abbreviated - application for drug approval for an existing licensed medication or approved drug

86
Q

what is NDA

A

new drug application - submitted after successful conclusion of clinical trials approx 8-9 yrs after animal and human testing

87
Q

What is a Patent?

A

lasts approx 20 yrs after applying prior to phase 1 of testing
other companies can file ANDA to sell the same product without clinical trial testing
gives the patent holder the exclusive right to manufacture, use, sell, and distribute the drug for a certain period, typically 20 years from the date of filing

88
Q

ex of patent and ANDA

A

ibuprofen is the generic name (note the small case lettering)
After patent expiration, the trade names for ibuprofen include
Advil
Caldolor
Genpril
I-Prin
Ibu-200
Midol Cramp and Body Aches
Motrin; Motrin Children’s, Motrin Junior, Motrin IB
Neoprofen

89
Q

Factors affecting drug cost and drug development

A

research & devleopment costs
includes FDA approval process
complicated manufacturing process
coverage and reimbursement for the drug by 3rd party payer (insurance)
desired profit margin of manufacturer
maximizing profits prior to patent expiration
export to other countries
determined by foreign government or negotiation
usually lower over seas

90
Q

what is the difference bw pharmacology and pharmacoepidemiology

A

pharmacology - basic and clinical applied science that deals with fate and actions of drugs in the body
pharmakon - poison or drugs
logos - study or discourse of
pharmacoepidemiology - study of drug outcomes
study of the use and effects of drugs in large populations
Applies the principles and methods of epidemiology to understand the patterns, causes, and effects of drug use and to evaluate the outcomes of drug therapies in the real world.

91
Q

basic and clinical applied science that deals with fate and actions of drugs in the body

A

pharmacology

92
Q

study of drug outcomes

A

pharmacoepidemiology

93
Q

study of the use and effects of drugs in large populations

A

pharmacoepidemiology

94
Q

Applies the principles and methods of epidemiology to understand the patterns, causes, and effects of drug use and to evaluate the outcomes of drug therapies in the real world.

A

Applies the principles and methods of epidemiology to understand the patterns, causes, and effects of drug use and to evaluate the outcomes of drug therapies in the real world.

95
Q

how early are they able to ask for a patent?

A

right after or before they find the molecule, during phase 1

96
Q

what is the avg time

A

12 yrs (8-15)

97
Q
A

Pharm & Ototoxicity (10 decks)

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