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Pharmacogenetics > Exam 2 lectures 14 & 15 > Flashcards

Exam 2 lectures 14 & 15 Flashcards

1
Q

targeted therapies are treatments that

A

target specific characteristics of diseased cells

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2
Q

targeted therapies are generally less

A

harmful to normal, healthy cells

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3
Q

targeted therapies can be various forms:

A

small molecules, RNA/DNA-based oligonucleotides, antibodies, & peptides/proteins

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4
Q

key factors in the discovery & development of targeted therapy

A
  • new technology
  • new targets
  • target validation in early development phase
  • predictive models
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5
Q

molecular targeted drug may target at various levels:

A

molecular, cellular, tissue/organ, system, whole body, population

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6
Q

effects of targeted therapy can be

A

physiological
biochemical
functional

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7
Q

criteria for target validation

A
  • causal relation between target & disease
  • correlation with disease status
  • specificity
  • affinity
  • mode of action (onset)
  • regulation of effects
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8
Q

methods of target validation

A
  • molecular/ genetic/ genomic
  • biochemical/proteomic
  • physiological/functional
  • pharmacological/ tocicological
  • population-based
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9
Q

testing system in target validation

A
  • cell-free in vitro
  • cell
  • organ (in vitro & in vivo)
  • small animals
  • non-human primates
  • humans
  • computational biology/bioinformatics
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10
Q

evaluation of target validation

A
  • qualitative (yes/no, withdrawal effect)
  • quantitative ( dose-effect& dose-response relationships)
  • biological effects vs. statistical signnificance
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11
Q

dose-effect

A

individual level

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12
Q

dose-response

A

group level

- most drugs are approved based on the population level

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13
Q

interpretation of target validation

A
  • geno vs pheno
  • in vitro vs in vivo
  • animals vs humans
  • healthy subjects vs patients
  • other host factors (age,, sex, race)
  • other limitations (dose-range)
  • research tools vs drug class/entiiy
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14
Q

biomarkers for selection of cancer therapy: EGFR

A
  • erlotinib (lung cancer)

- cetuximab (colon cancer)

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15
Q

biomarkers for selection of cancer therapy: HER2

A
  • trastuzumab (breast cancer)

- lapatinib (breast cancer)

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16
Q

biomarkers for selection of cancer therapy: KRAS

A

cetuximab (colon cancer)

17
Q

oncotype DX scoring

A
  • for breast cancer therapy with tamoxifen
  • recurrence score
  • 31 high risk (benefit from chemo)
18
Q

MammaPrint

A
  • breast cancer therapy
  • predict risk of metastasis
  • aggressive therapy can be considered for those with poor prognosis
  • for pts <61, early stage I & II
19
Q

DPD (Dihydroprimidine dehydrogenase)

A
  • drug disposition in cancer therapy

- DPD responsible for >85% 5-FU breakdown

20
Q

thymidylate synthase (TS)

A
  • drug disposition in cancer therapy
  • molecular target for 5-FU
  • over expression linked to drug resistance
21
Q

PGX factors in targeted therapy

A 
genetic variations in pathogens, targeted genes, in genes associated with drug metabolism/dispoition, & in signalling pathways involved in drug response & toxicity
other factors (interactions & physiology/disease status)
22
Q

purpose of PG testing

A
  • provide evidence for PG variations
  • improve healthcare outcome by enhancing selection & dosing of therapy
  • provide rationale for stratification of subjects in clinical studies
  • facilitate PG research & developing novel drugs
23
Q

CYP2D6/PM

A
  • poor response to tamoxifen
  • for postmenpausal women with breast cancer can be treated with aromatoase inhibitor
  • in pre-&perimenopausal women, no alternative therapy
  • test can be used for monitoring response & prognosis
24
Q

nocebo

A

negative response to treatment

- can be an effect of PG testing

25
Q

selection of target patient population: conventional approaches

A
  • age. sex, race, etc
  • disease status, pathology, stage
  • co-morbidity
  • physiology/ pathology,: prego, liver & kidney function
26
Q

PG approaches add on

A 
PK characteristics (ADME: disease-independent)-differentiating people
- PD characteristics (disease subtype)- differentiating disease
27
Q

approval of race-targeted drug BiDil

A
  • fixed dose of isosorbide dinitrate & hydralazine hcl
  • indication: HF; adjunct to standard therapy; black people
  • commercial failure; negative publicity; high cost compared to the 2 separate drugs alone
  • no comparison to other racial groups
28
Q

about — drugs prescribed to children were not tested in children; they are not labeled for pediatric use

A

2/3

29
Q

policies developed to encourage testing drugs in children

A
  • pediatric research equity act
  • best pharmaceuticals for children act
  • marking incentive: 6-month exclusivity
30
Q

PG considerations in children

A
  • developmental changes in gene expression in children
  • metabolizing enzymes-age related
  • pediatric diseases vs adult diseases
  • clinical trials in children- minimal risk
  • including children in clinical trials
  • including children in PG testing
31
Q

lawsuit of lyme vaccine

A
  • LYMeric
  • OspA triggers development of autoimmune arthritis in individuals with HLA-DR4 gene
  • withdrawn from market
32
Q

OBRA90

A

pharmacist has to inform patient of risk of ADE if known genetic variant in patient or it will be a breach of duty

33
Q

if PGX testing is considered different for traditional genetic testing

A

a detailed consent form is probably NOT needed

34
Q

formal consent form needed if:

A

familial implication
ancillary info needed
risk of discrimination
laws

35
Q

under federal law & laws of many states

A

individuals DO NOT own their health data or stored specimens (at least in the sense of medical research)

36
Q

HIPAA pricacy rule distinguishes

A

individually identifiable health info (IIHI) from de-identified health info

37
Q

in general, disclosure or research use of IIHI needs

A

informed consent

38
Q

de-identified health info can be used

A

without authorization

39
Q

major goal of PG in clinical trials

A

stratify patients- improve response & reduce side effects

Pharmacogenetics (8 decks)

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