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FTCM > DLA4, DLA5- Drug Development and Adverse Effects > Flashcards

DLA4, DLA5- Drug Development and Adverse Effects Flashcards

1
Q

define the 4 types of ADRs

A 
(ADR- adverse drug reaction)
Type A- explainable/predictable ADR
Type B- unexplainable/idiosyncratic ADR
Type C- chronic ADR
Type D- delayed ADR
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2
Q

Most ADR are type (1), accounting for (2)%. It includes the following examples: (3).

A

1- type A, explainable / predictable
2- 80%
3- toxicity of overdose, side effects, secondary effects, drug interaction

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3
Q

Type A ADR is dose (in-/dependent)

Type B ADR is dose (in-/dependent)

A

A- dose dependent

B- dose independent

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4
Q

list some examples of Type B ADRs

A
  • intolerance
  • hypersensitivity
  • pseudoallergic (first exposure, unlike in type I hypersensitivity)
  • idiosyncratic (unpredictable reactions)
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5
Q

describe Type C ADR

A
  • only occurs with long-term drug use
  • ex. dependence / withdrawal associated
  • ex. some effects only appear after long-term use (steroids)
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6
Q

describe Type D ADR

A
  • delayed ADR
  • usually carcinogenic / teratogenic
  • rare, commonly associated with chemotherapeutic agents
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7
Q

list the 5 mechanisms of drug toxicity

A
  • on-target adverse effects
  • off-target adverse effects
  • toxic metabolite production
  • harmful immune response production
  • idiosyncratic responses
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8
Q

compare on-target and off-target drug toxicities

A

ON- either too much stimulation of receptor (i.e. hypoglycemia from insulin) or activating same receptor in non-target tissue (i.e. His receptors in CNS) [same receptor]

OFF- drug binds additional receptor(s) in target and or non-target tissue [different receptor]; Note this can include enantiomer of drug with different effects

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9
Q

95% of acetominophen is metabolized by (1). The remaining 5% is oxidized by (2) forming (3), a reactive intermediate. (3) is conjugated with (4) in non-toxic doses, but in toxic doses (4) stores are depleted and (5) occurs.

A 
1- glucuronidation, sulfation
2- cytochrome P450
3- NAPQI (N-acetyl-benzoquinineimine)
4- glutathione
5- cell death
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10
Q

describe the two types of harmful immune responses to drugs

A

1) hypersensitivity / allergic response

2) autoimmune reactions

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11
Q

list the inducers of cytochrome P450

A

chronic EtOH use, rifampin, phenytoin, phenobarbital, carbamazepine, St. John’s Wort
(mostly seizure drugs)

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12
Q

list the inhibitors of cytochrome P450

A

cimetidine, ketoconazole, clarithromycin, quinidine, sulfonamides, ciprofloxacin, grapefruit juice
(mostly antibiotics)

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13
Q

gingko biloba has a _____ effect

A

inhibits platelet aggregation

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14
Q

St. John’s wort has a _____ effect

A

antidepressant

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15
Q

list the results of cellular toxicity

A
  • apoptosis
  • fibrosis
  • carcinogenesis
  • teratogenesis
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16
Q

list the categories for classifying drug use in pregnancy (hint- 5)

A

A- adequate, no risk to fetus
B- animal studies show adverse effects, no evidence seen in with studies in pregnant women
C- animals studies shoe adverse effects or have not been conducted, no studies with pregnant women conducted
D- studies show risk to fetus, however benefits can outweigh potential risks
X- studies show risk to fetus, do not give to pregnant women

17
Q

list the 5 approaches to discovering or developing a new drug

A
  • identification of new drug target
  • rational design of new molecule based on understanding biological mechanisms and drug receptor structure
  • chemical modification of known molecule
  • screening for biologic activity via large number of natural products (previously discovered chemical entities)
  • combination of known drugs
18
Q

FDA determines safety and efficacy of a drug through (1) studies, then (2) studies, and finally (3) studies

A

1- in vitro
2- in vivo
3- RCTs

19
Q

list the three quantitative estimated in preclinical testing

A
  • no-effect dose: max dose where specific toxic effect is not seen
  • minimum lethal dose: smallest dose that killsexperimental animal
  • LD50: dose at which 50% of experimental animals die
20
Q

describe the approach and goal of Acute Toxicity preclinical testing

A
  • determine no-effect dose

- determine maximum tolerated dose

21
Q

describe the approach and goal of Subacute or Subchronic Toxicity preclinical testing

A
  • 2 wks to 3 mos

- determines biochemical and physiological effects

22
Q

describe the approach and goal of Chronic Toxicity preclinical testing

A
  • used if drug will need to be used in humans for long periods
  • runs concurrently with RCTs
  • determines biochemical and physiological effects
23
Q

describe the approach and goal of Effect on Reproductive Performance preclinical testing

A

test effects of animal mating behavior, reproduction, parturition, progeny, birth defects, postnatal development

24
Q

describe the approach and goal of Carcinogenic Potential preclinical testing

A
  • used if drug will need to be used in humans for long periods
  • determines gross and histological pathology
25
Q

describe the approach and goal of Mutagenic Potential preclinical testing

A

test effects on genetic stability and mutations in bacteria or mammalian cells in culture

26
Q

describe the approach and goal of Investigative Toxicology preclinical testing

A

-determines sequence & mechanism of toxic action
-discover genes, proteins, pathways involved
(-develop new methods for assessing toxicity, like computer assisted modeling)

27
Q

what are the limitations of preclinical testing

A
  • time-consuming, expensive
  • large number of animals required
  • extrapolation of animals results to humans aren’t always accurate
  • rare adverse effects are unlikely to be detected
28
Q

list the number of subjects, length of phase, and purpose of Prephase I clinical trials

A
  • Number: small
  • Length: short, hr-days
  • Purpose: facilitate efficient drug development
29
Q

list the number of subjects, length of phase, and purpose of Phase I clinical trials

A
  • Number: 20-100
  • Length: months
  • Purpose: safety
30
Q

list the number of subjects, length of phase, and purpose of Phase II clinical trials

A
  • Number: hundreds
  • Length: months - 2 yrs
  • Purpose: effectiveness, short-term safety
31
Q

list the number of subjects, length of phase, and purpose of Phase III clinical trials

A
  • Number: hundreds - thousands
  • Length: 1-4 yrs
  • Purpose: safety, dosage, effectiveness
32
Q

list the number of subjects, length of phase, and purpose of Phase IV clinical trials

A
  • Number: unlimited
  • Length: unlimited
  • Purpose: observe adverse effects
33
Q

define Black Box Warning

A

-FDA assigns it to a drug if studies show it carries significant risk of serious or life-threatening adverse effects

34
Q

define Orphan drugs

A

-drugs that are being research for rare diseases, which provides many obstacles
Defined as:
-affects <200,000 people in US
-affects >200,000 people in US, no expectation cost of drug will be recovered by its sales

35
Q

drugs can receive ‘fast-track’ status if…

A

they are for serious. life-threatening diseases

  • don’t need to meet all regular drug requirements
  • can be ‘fast-tracked’ off the market too
36
Q

define the Schedule classes of drugs

A

1- high potential for abuse, all non-research use is illegal under federal law
2- high potential for abuse, no telephone Rxs, no refills
3- abuse potential less than 1/2, Rx rewritten after 6 mos or 5 refills
4- abuse potential less than 3, Rx rewritten after 6 mos or 5 refills (illegal possession has different penalties)
5- abuse potential less than 4, no Rx required (depends on state)

37
Q

New Drug Application occurs after Phase (1) trials and can (2) amount of time

A

1- phase 3

2- mos-yrs

FTCM (16 decks)

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