Pharmacogenomics Flashcards

1
Q

define Pharmacogenomics

A

study of how genes affect a person’s response to drugs.

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2
Q

define Pharmacogenetics

A

the effect of genetic variation on drug response, including disposition, safety and tolerability, and efficacy.

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3
Q

what is the process of translation?

A

gene to protein

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4
Q

define a polymorphism

A

1 out of every 1220 bases can be different in humans

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5
Q

what type of polymorphism is the most common type of genetic variation among people?

A

Single nucleotide polymorphisms (SNPs)

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6
Q

what is the overall goal of drug metabolism?

A

Drug is enzymatically transformed into a polar, water-soluble, and excretable metabolite.

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7
Q

the variant CYP2D6*2xn would result in?

A

increased enzyme activity

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8
Q

the variant CYP2D6*4 would result in?

A

an inactive enzyme

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9
Q

the variant CYP2D6*5 would result in?

A

no enzyme

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10
Q

the variant CYP2D6*10 would result in?

A

an unstable enzyme

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11
Q

the variant CYP2D6*17 would result in?

A

altered affinity for substrates

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12
Q

define biosimilar

A

there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product

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13
Q

define reference product

A

the initial biopharmaceutical that has been approved by regulatory agencies for specific indications

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14
Q

define biomimic

A

a biopharmaceutical, claimed to have high similarity with a given reference product, that has not undergone full clinical development and has not achieved regulatory approval

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15
Q

define biosimilar agent

A

a monoclonal antibody or fusion protein that has undergone a complete development process

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16
Q

how long do biotech companies have after a biologic drug is approved before biosimilars can be produced?

A

12 years

17
Q

what is contained in the purple book?

A

Lists all approved biologics

18
Q

what does Adalimumab target?

A

necrosis factor a

19
Q

what is Adalimumab approved to treat?

A

RA, psoriasis, ulcerative colitis, and ankylosing spondylitis