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PHRM 824 Final > Exam 6/Final Material > Flashcards

Exam 6/Final Material Flashcards

(81 cards)

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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
Investigational New Drug Application
An application to begin administering a drug to human subjects
26
New drug applications
An application to receive approval to market a new drug
27
Generally recognized as safe
Compounds whose safety in humans has been established, if included toxicology data is not needed
28
Goal of preclinical studies
Determine nature of risk and minimize it
29
Effect of single dose in at least 2 species
Acute studies
30
Length depends on anticipated therapy in at least 2 species
repeated dose studies
31
Determine likelihood compound is mutagenic or carcinogenic
Genetic toxicity
32
Need depends on target population, multiple species
Reproductive toxicity
33
Only for compounds used in chronic or recurring conditions
Carcinogenicity
34
Off target response Marginal impact on health May impact patient compliance
Side effects
35
Extension of pharmacological effect Dose dependent May seriously impair health Bradycardia with propanolol
Augmented responses
36
Not predicted from pharmacology of drug Sometimes not dose dependent Can seriously impact health Carbamazepine induced liver injury
Toxic reactions
37
Four determinants of toxic drug responses
Individual susceptibility Accessibility of drug to target Compensatory mechanisms Reactivity of drug with target
38
Diet, genetics, environment, underlying disease
Individual susceptibility
39
Compensatory mechanisms
blood pH compatible
40
Somatic cell damage outcome
Cancer
41
Germ cell damage outcome
Birth defects, childhood cancers
42
Developing embryo damage outcome
Miscarriages, still births, birth defects
43
Disruption of normal cellular functions that does not result in cell death
Cellular dysfunction
44
Dysregulation of cellular processes provoked by a toxicant resulting in the death of the cell
Cellular destruction
45
Damage to genetic material caused by external agent
Genotoxicity
46
Embryo death weeks
1-2 weeks
47
Major congenital anomalies weeks
3-8 weeks
48
Functional defects and minor anomalies weeks
Weeks 9-38
49
Malformations, exposure at specific stage of development, dose dependent effect
Criteria for teratogen classification
50
DES effects in women exposed in utero
Higher infertility rates 40x more chance of clear cell adenocarcinoma
51
Augmented response
Exaggerated response to a drug due to an excessive dose of greater than usual sensitivity
52
Damage to an organism that causes abnormality in development
Teratogenicity
53
An agent that causes damage to DNA
Mutagen
54
A low frequency serious adverse drug reaction with an immunological etiology to an otherwise safe and effective therapeutic agent
Drug induced hypersensitivity
55
A low mw chemical with propensity to bind irreversibly to protein. May or may not stimulate an immune response
Hapten
56
A substance that interacts with dendritic cells, stimulating maturation and possible polarization of an immune response
Costimulatory agent
57
A substance that stimulates an immune response having stimulatory capacity for the innate and adaptive immune systems
Immunogen
58
A substance that interacts with high affinity with immunologic receptors
Antigen
59
A rash that exhibits erythematous macules or papules most commonly initially appearing on the trunk
Exanthema
60
A rash that appears as flat distinct colored area less than 1 cm in area
Macule
61
A raised rash with distinct color overall size less than 1cm
Papule
62
DRESS
Drug reaction with Eosinophilia and Systemic Symptoms distinguished by involvement of internal organs and skin
63
Four key principles of DIHR
Rare, unpredictable, complex, potentially fatal
64
Reactions occur within one hour of last dose, Type 1 immunologically, IgE mediated
Immediate hypersensitivity
65
Reaction occurs more than 1 hour after last dose, type 4 or 3, T cell mediated
Delayed hypersensitivity
66
Hypersensitivity reactions require what phases
Sensitization and effector
67
Anaphylaxis consists of
Respiratory and cardiovascular manifestations, swelling of lips, tongue, or throat
68
Most patients with penicillin allergy lose sensitivity within how long
10 years
69
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?
Applicability
70
Acute preclinical toxicology studies are conducted in at least how many species?
2
71
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
The GRAS list
72
The safety factor most commonly used for calculating the first dose in humans from animal studies is
10
73
Which of the following toxic responses to a drug is most likely to be associated with methemoglobinemia while taking the drug?
Cellular dysfunction
74
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)
Side effect
75
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
Accessibility of drug to target
76
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
Decreased risk for liver injury
77
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?
Embryo death
78
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
IgE Mediated
79
DRESS is primarily differentiated from other DIHRs by
Internal organ involvement
80
Most people who claim to be allergic to penicillin can safely take the drug
True
81
Time frame at which most drug reactions occur
4-14 days or 1-3 weeks

PHRM 824 Final (4 decks)

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