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PHRM 824 Final > Exam 6/Final Material > Flashcards

Exam 6/Final Material Flashcards

1
Q

The study of adverse effects of chemical or physical agents on living systems

A

Toxicology

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2
Q

A poisonous substance produced by living cells

A

Toxin

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3
Q

A man-made chemical introduced into the environment that produces toxic effects on living cells

A

Toxicant

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4
Q

An area of focus in toxicology which is concerned with determining the toxic responses to agents

A

Descriptive toxicology

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5
Q

An area of focus concerned with determining why or how agents provoke a toxic response

A

Mechanistic toxicology

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6
Q

An area of focus in toxicology that is concerned with assessing the risks of toxic substances and determining how that risk is best managed

A

Regulatory toxicology

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7
Q

LOAEL

A

Lowest observable adverse effect level

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8
Q

NOAEL

A

No observable effect level

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9
Q

Seconds to hours

A

Immediate

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10
Q

Days to years

A

Delayed

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11
Q

Effect abates after stopping exposure

A

Reversible

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12
Q

Effect persists after stopping exposure

A

Irreversible

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13
Q

Source/environment, ingestion, inhalation, dermal

A

Exposure

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14
Q

Traveling through the body

A

Disposition

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15
Q

Cellular responses

A

Toxicodynamics

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16
Q

Three means by which toxic responses may be mitigated

A

Prevent/reduce exposure
Enhance elimination from body
Block/repair cellular effects

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17
Q

Three levels of risk benefit analysis

A

Accessibility, applicability, acceptability

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18
Q

Accessibility

A

FDA evaluates the benefits/risks for the population

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19
Q

Applicability

A

Provider evaluates benefits/risks for a patient

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20
Q

Acceptability

A

Patient evaluates benefits/risks in terms of personal values

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21
Q

Three elements needed for IND with the FDA

A

Animal pharmacology and toxicology, manufacturing information
Clinical protocol and investigator information

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22
Q

MRSD

A

Maximum recommended starting dose

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23
Q

Primary reason adverse drug events are not detected until after drug is approved

A

Rare effect in small amount of people

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24
Q

Five categories of preclinical studies

A

Acute, Repeated dose, Genetic toxicity, reproductive toxicity, carcinogenicity

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25
Q

Investigational New Drug Application

A

An application to begin administering a drug to human subjects

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26
Q

New drug applications

A

An application to receive approval to market a new drug

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27
Q

Generally recognized as safe

A

Compounds whose safety in humans has been established, if included toxicology data is not needed

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28
Q

Goal of preclinical studies

A

Determine nature of risk and minimize it

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29
Q

Effect of single dose in at least 2 species

A

Acute studies

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30
Q

Length depends on anticipated therapy in at least 2 species

A

repeated dose studies

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31
Q

Determine likelihood compound is mutagenic or carcinogenic

A

Genetic toxicity

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32
Q

Need depends on target population, multiple species

A

Reproductive toxicity

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33
Q

Only for compounds used in chronic or recurring conditions

A

Carcinogenicity

34
Q

Off target response
Marginal impact on health
May impact patient compliance

A

Side effects

35
Q

Extension of pharmacological effect
Dose dependent
May seriously impair health
Bradycardia with propanolol

A

Augmented responses

36
Q

Not predicted from pharmacology of drug
Sometimes not dose dependent
Can seriously impact health
Carbamazepine induced liver injury

A

Toxic reactions

37
Q

Four determinants of toxic drug responses

A

Individual susceptibility
Accessibility of drug to target
Compensatory mechanisms
Reactivity of drug with target

38
Q

Diet, genetics, environment, underlying disease

A

Individual susceptibility

39
Q

Compensatory mechanisms

A

blood pH compatible

40
Q

Somatic cell damage outcome

A

Cancer

41
Q

Germ cell damage outcome

A

Birth defects, childhood cancers

42
Q

Developing embryo damage outcome

A

Miscarriages, still births, birth defects

43
Q

Disruption of normal cellular functions that does not result in cell death

A

Cellular dysfunction

44
Q

Dysregulation of cellular processes provoked by a toxicant resulting in the death of the cell

A

Cellular destruction

45
Q

Damage to genetic material caused by external agent

A

Genotoxicity

46
Q

Embryo death weeks

A

1-2 weeks

47
Q

Major congenital anomalies weeks

A

3-8 weeks

48
Q

Functional defects and minor anomalies weeks

A

Weeks 9-38

49
Q

Malformations, exposure at specific stage of development, dose dependent effect

A

Criteria for teratogen classification

50
Q

DES effects in women exposed in utero

A

Higher infertility rates
40x more chance of clear cell adenocarcinoma

51
Q

Augmented response

A

Exaggerated response to a drug due to an excessive dose of greater than usual sensitivity

52
Q

Damage to an organism that causes abnormality in development

A

Teratogenicity

53
Q

An agent that causes damage to DNA

A

Mutagen

54
Q

A low frequency serious adverse drug reaction with an immunological etiology to an otherwise safe and effective therapeutic agent

A

Drug induced hypersensitivity

55
Q

A low mw chemical with propensity to bind irreversibly to protein. May or may not stimulate an immune response

A

Hapten

56
Q

A substance that interacts with dendritic cells, stimulating maturation and possible polarization of an immune response

A

Costimulatory agent

57
Q

A substance that stimulates an immune response having stimulatory capacity for the innate and adaptive immune systems

A

Immunogen

58
Q

A substance that interacts with high affinity with immunologic receptors

A

Antigen

59
Q

A rash that exhibits erythematous macules or papules most commonly initially appearing on the trunk

A

Exanthema

60
Q

A rash that appears as flat distinct colored area less than 1 cm in area

A

Macule

61
Q

A raised rash with distinct color overall size less than 1cm

A

Papule

62
Q

DRESS

A

Drug reaction with Eosinophilia and Systemic Symptoms distinguished by involvement of internal organs and skin

63
Q

Four key principles of DIHR

A

Rare, unpredictable, complex, potentially fatal

64
Q

Reactions occur within one hour of last dose, Type 1 immunologically, IgE mediated

A

Immediate hypersensitivity

65
Q

Reaction occurs more than 1 hour after last dose, type 4 or 3, T cell mediated

A

Delayed hypersensitivity

66
Q

Hypersensitivity reactions require what phases

A

Sensitization and effector

67
Q

Anaphylaxis consists of

A

Respiratory and cardiovascular manifestations, swelling of lips, tongue, or throat

68
Q

Most patients with penicillin allergy lose sensitivity within how long

A

10 years

69
Q

The action of a prescriber in selecting a drug for a particular patient is an example
of what element(s) of assessing the risk:benefit ratio for a drug?

A

Applicability

70
Q

Acute preclinical toxicology studies are conducted in at least how many species?

A

2

71
Q

The FDA does not require preclinical toxicology studies of non-drug components
(excipients) of a new drug as long as they are already included in

A

The GRAS list

72
Q

The safety factor most commonly used for calculating the first dose in humans from
animal studies is

A

10

73
Q

Which of the following toxic responses to a drug is most likely to be associated
with methemoglobinemia while taking the drug?

A

Cellular dysfunction

74
Q

Patients receiving a tricyclic antidepressant frequently complain of a dry mouth due
to the anticholinergic effects of the drug. This is an example of a(n)

A

Side effect

75
Q

Patients receiving some beta-blockers complain of experiencing frequent
nightmares. Some beta-blockers are less lipophilic and have a lower penetration
into the brain and, as a consequence, are rarely associated with nightmares. This
is an example of an adverse effect determined by

A

Accessibility of drug to target

76
Q

The liver injury associated with acetaminophen is caused by a toxic metabolite. In
patients also taking a drug inhibiting the CYP450 responsible for this metabolism
would be expected to be at

A

Decreased risk for liver injury

77
Q

Exposure of a pregnant woman to a teratogen in the 2 nd week of pregnancy is most
likely to result in what kind of impact?

A

Embryo death

78
Q

RB received a dose of cephalexin and within 30 minutes developed wheezing and
a raised skin rash across her chest and face. This is most likely a reaction that is

A

IgE Mediated

79
Q

DRESS is primarily differentiated from other DIHRs by

A

Internal organ involvement

80
Q

Most people who claim to be allergic to penicillin can safely take the drug

A

True

81
Q

Time frame at which most drug reactions occur

A

4-14 days or 1-3 weeks

PHRM 824 Final (4 decks)

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