Pharmacogenomics Flashcards
define Pharmacogenomics
study of how genes affect a person’s response to drugs.
define Pharmacogenetics
the effect of genetic variation on drug response, including disposition, safety and tolerability, and efficacy.
what is the process of translation?
gene to protein
define a polymorphism
1 out of every 1220 bases can be different in humans
what type of polymorphism is the most common type of genetic variation among people?
Single nucleotide polymorphisms (SNPs)
what is the overall goal of drug metabolism?
Drug is enzymatically transformed into a polar, water-soluble, and excretable metabolite.
the variant CYP2D6*2xn would result in?
increased enzyme activity
the variant CYP2D6*4 would result in?
an inactive enzyme
the variant CYP2D6*5 would result in?
no enzyme
the variant CYP2D6*10 would result in?
an unstable enzyme
the variant CYP2D6*17 would result in?
altered affinity for substrates
define biosimilar
there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product
define reference product
the initial biopharmaceutical that has been approved by regulatory agencies for specific indications
define biomimic
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
define biosimilar agent
a monoclonal antibody or fusion protein that has undergone a complete development process
how long do biotech companies have after a biologic drug is approved before biosimilars can be produced?
12 years
what is contained in the purple book?
Lists all approved biologics
what does Adalimumab target?
necrosis factor a
what is Adalimumab approved to treat?
RA, psoriasis, ulcerative colitis, and ankylosing spondylitis
