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PHRM824 > Final Lectures > Flashcards

Final Lectures Flashcards

1
Q

The study of the 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 in toxicology 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

What was the similarity between marijuana and K2?

A

Both attach to CB receptor

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8
Q

Describes where in the body
A. Local vs systemic
B. Immediate vs Delayed
C. Reversible vs irreversible

A

A. Local vs systemic

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9
Q

Where is the site of entry in local vs systemic?

A

Local- At site of contact or entry
Systemic- At site distant from contact or entry

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10
Q

What is the time between immediate vs delayed?

A

Immediate- seconds to hours
Delayed- Days to years

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11
Q

What is the type of exposure in reversible vs irreversible?

A

reversible- abates after stopped exposure
irreversible- persists after stopping exposure

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12
Q

Toxic effect associated with time and source in environment

A

exposure

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13
Q

Toxic effect phase in the body and where it goes

A

Disposition

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14
Q

Toxic effect cellular response

A

Toxicodynamics

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15
Q

Lowest observable adverse effect level

A

LOAEL

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16
Q

The highest dose of an agent that does not produce an adverse effect.

A

NOAEL

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17
Q

KD is 68 year old female who presents to the emergency room with history of a spider bite approximately ½ hour prior to arrival. She presents with stomach and shoulder pain, sweating, headache and complaining of feeling light headed. Her blood pressure and respiration are both elevated. The patient’s husband took a picture of the spider on his smartphone, which is quickly identified as a black widow spider. Based upon the time frame of this patient’s symptoms, this would be classified as a(n)
A. delayed toxic reaction
B. immediate toxic reaction

Since the reaction in the case presented above was provoked by a spider on the
skin, this would be classified as a
a. Local reaction
b. Systemic reaction

A

B. immediate toxic reaction

B. systemic reaction

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18
Q

While in the emergency, the patient above continued to experience high blood pressure and developed chest pains. The patient was treated with black widow antivenom and agents to reduce blood pressure. The use of antivenom represents an intervention at what level?
a. Toxicodynamics
b. Exposure
c. Disposition

The spider venom to which this patient was exposed is an example of a
a. Toxicant
b. Toxin
c. Tuberculin

A

a. Toxicodynamics
b. Toxin

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19
Q

Level of Risk Benefit analysis that is evaluated for the population
A. Acceptability
B. Accessibility
C. Applicability

A

B. Accessibility

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20
Q

Level of Risk Benefit analysis that is evaluated for a patient
A. Acceptability
B. Accessibility
C. Applicability

A

C. Applicability

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21
Q

Level of Risk Benefit analysis that is evaluated in terms of personal values
A. Acceptability
B. Accessibility
C. Applicability

A

A. Acceptability

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22
Q

This is filed between preclinical development and Phase 1 (between 1-6 months)

A

Investigational New Drug (IND)

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23
Q

Application to receive approval to market a new drug. Between Phase III and Launch/Phase IV, the drug has over 6 months of assessment and is being monitored for adverse events.

A

New Drug Application (NDA)

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24
Q

A group of compounds whose safety in
humans has been established through careful study or widespread use. If included in a
drug formulation as excipients, specific toxicology data is not needed for these
compounds.

A

Generally Recognized As Safe (GRAS)

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25
Q

Match:
A. Acute Studies
B. Repeated Dose Studies
C. Genetic Toxicity
D. Reproductive Toxicity
E. Carcinogenicity

  1. Length depends on anticipated therapy; at least 2 species
  2. Needs depends on target population; multiple species
  3. Only for cmpds used in chronic or recurring conditions
  4. Effect of single dose; at least 2 species
  5. Determine likelihood cmpd is mutagenic or carcinogenic
A

A-4
B-1
C-5
D-2
E-3

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26
Q

What are the four steps for predicting the first dose in man for a new drug?

A

Step 1: Determine the max NOAEL in appropriate animal species
Step 2: Calculate HED from appropriate species
Step 3: Determine a safety factor (usually 10)
Step 4: Divide HED by safety factor to determine MRSD

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27
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. Accessibility
b. Applicability
c. Acceptability

A

b. Applicability

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28
Q

Acute preclinical toxicology studies are conducted in at least how many species?
a. 2
b. 3
c. 4
d. 5

A

a. 2

29
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 US Pharmacopeial Compendium of safe excipients
b. The PhRMA list of approved excipients
c. The GnPhA list
d. The GRAS list

A

d. The GRAS list

30
Q

The safety factor most commonly used for calculating the first dose in humans from animal studies is
a. 2
b. 5
c. 10
d. 50

A

c. 10

31
Q

Off-target effects of a drug that are bothersome but do not meaningfully impact the health of a patient.

A

side effects

32
Q

An exaggerated response to a drug due to an excessive dose or greater than usual sensitivity to the drug.

A

augmented response

33
Q

Responses that are not expected based upon the targeted pharmacologic effect and put the patient’s health at serious risk.

A

toxic response

34
Q

Toxic drug response involving diet, genetics, environment, and underlying disease
A. Accessibility of Drug to Target
B. Reactivity of Drug with Target
C. Compensatory Mechanisms
D. Individual Susceptibility

A

D. Individual Susceptibility

35
Q

How well does drug get to target, stay at target, and its accessibility
A. Accessibility of Drug to Target
B. Reactivity of Drug with Target
C. Compensatory Mechanisms
D. Individual Susceptibility

A

A. Accessibility of Drug to Target

36
Q

Ability to compensates for cellular insults
A. Accessibility of Drug to Target
B. Reactivity of Drug with Target
C. Compensatory Mechanisms
D. Individual Susceptibility

A

C. Compensatory Mechanisms

37
Q

Interaction with drug to target
A. Accessibility of Drug to Target
B. Reactivity of Drug with Target
C. Compensatory Mechanisms
D. Individual Susceptibility

A

B. Reactivity of Drug with Target

38
Q

Most toxic drug reactions are mediated through ______ ____________

A

reactive metabolites

39
Q

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

A

Cellular Dysfunction

40
Q

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

A

Cellular Destruction

41
Q

Damage to genetic material caused by an external agent

A

Genotoxicity

42
Q

Damage to an organism that causes an abnormality in development

A

Teratogenicity

43
Q

An agent that causes damage to DNA

A

Mutagen

44
Q

Which type of cells cause many forms of cancers?
A. Somatic cells
B. Germ cells
C. Developing embryo

A

A. Somatic cells

45
Q

Which type of cells cause birth defects and childhood cancers?
A. Somatic cells
B. Germ cells
C. Developing embryo

A

B. Germ cells

46
Q

Which type of cells cause miscarriages, stillbirths, and birth defects?
A. Somatic cells
B. Germ cells
C. Developing embryo

A

C. Developing embryo

47
Q

What happens to Methemoglobin from oxidative stress in RBC? G6PD? What is the primary mechanism:
Cell dysfunction, cell destruction or genotoxicity

A

Cell Dysfunction:
increase in oxidative stress in RBC= increase methemoglobin
Decrease in G6PD RBC= increase methemoglobin

48
Q

What are the three primary targets of cell destruction?

A

ATP depletion, Ca accumulation, and ROS/RNS generation

49
Q

True/False: Teratogen effect is dose independent

A

False: Dose dependent

50
Q

Match the weeks with the gestational teratogenic effect:
A. 1-2 weeks
B. 3-8 weeks (Main embryonic period)
C. 9-38 weeks (fetal periods)

  1. Functional defects and minor abnormalities
  2. Death of embryo and spontaneous abortion
  3. Major congenital abnormalities
A

A. 2
B. 3
C. 1

51
Q

Which of the following toxic responses to a drug is most likely to be associated with methemoglobinemia while taking the drug?
a. Cellular destruction
b. Cellular dysfunction
c. Neoantigen formation
d. Mitochondrial dysregulation
e. Lipid peroxidation

A

b. Cellular dysfunction

52
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. Augmented response
b. Side effect
c. Toxic reaction

A

b. Side effect

53
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. Individual susceptibility
b. Accessibility of drug to target
c. Compensatory mechanisms
d. Reactivity of the drug

A

b. Accessibility of drug to target

54
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. Increased risk for liver injury
b. Decreased risk for liver injury
c. Similar risk to people not taking the interacting drug
d. Not enough information provided to answer this question

A

b. Decreased risk for liver injury

55
Q

Exposure of a pregnant woman to a teratogen in the 2nd week of pregnancy is most likely to result in what kind of impact?
a. Embryo death
b. Major congenital abnormality
c. Functional defects
d. Minor anomalies

A

a. Embryo death

56
Q

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

A

Drug-induced hypersensitivity

57
Q

A low molecular weight chemical with the propensity to bind irreversibly to protein; might or might not stimulate an immune response

A

Hapten

58
Q

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

A

Costimulatory agent

59
Q

Of the two types of DIHR hypersensitivity
(immediate and delayed) identify:
-Time
-Type
-Cell that is mediating

A

Immediate: occur within 1 hr; Type I; Ig-E mediated
Delayed: occurs > 1 hr; Type IV or III; T cell-mediated

60
Q

A a substance that stimulates an immune response, having stimulatory capacity for the innate and adaptive immune systems
a. antigen
b. immunogen

A

b. immunogen

61
Q

A substance that interacts with high affinity with immunologic receptor
a. antigen
b. immunogen

A

a. antigen

62
Q

A rash that exhibits erythematous macules or papules, most commonly initially appearing on the trunk
A. Macule
B. Exanthema
C. Papule

A

B. Exanthema

63
Q

A rash that appears as flat, distinct colored area less than 1 cm in area
A. Macule
B. Exanthema
C. Papule

A

A. Macule

64
Q

A raised rash with distinct color that may have distinct or non-distinct edges, with overall size <1 cm
A. Macule
B. Exanthema
C. Papule

A

C. Papule

65
Q

Two primary reasons most people who claim they have a penicillin allergy actually don’t

A
  • 50% of people with IgE-mediated PCN allergy lose sensitivity within 5 years; >80% by 10 years
  • The rash is caused by concurrent viral infections
66
Q

Which of the following is not a key characteristic of DIHRs?
a. Rare
b. predictable
c. complex
d. potentially fatal

A

b. predictable

67
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
b. T cell-mediated

A

a. IgE-mediated

68
Q

Most people who claim to be allergic to penicillin can safely take the drug.
a. True
b. False

A

a. True

69
Q

DRESS is primarily differentiated from other DIHRs by
a. Significant mortality
b. The extent of skin involvement
c. Internal organ involvement
d. The causative drugs
e. None of the above

A

c. Internal organ involvement

PHRM824 (6 decks)

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