History of Healthcare
The first-mass produced antibiotic known as the wonder drug in the 1940's
What is penicillin
Chemically identical drug that must demonstrate bioequivalence
What is a generic
Approximately 50% of the drug that is absorbed from this route will reach systemic circulation
What is the rectal route
What is rectal
The Food Drug & Cosmetic Act of 1938 required drugs to be shown to be ____ prior to introduction into the market
What is safe
A protein that binds drugs or ligands to trigger a cellular response
What is a receptor
Theory proposed in 1500's but not adopted until the 20th century
What is Germ Theory
The study of genetic factors that affect drug responses
What is pharmacogenomics
Route of administration that bypasses first-pass metabolism
What is sublingual
The rate of drug administration equals the rate of elimination (after about 5 half-lives)
What is steady state
A drug that binds to a receptor, not producing an effect and blocking endogenous substances from binding to it.
What is an antagonist?
Concept that the human body is interrelated and in natural balance
What is humoralism
An FDA-approved drug used for a NON-FDA approved reason that has shown value postmarketing
What is off-label
Enzyme family responsible for most oxidative metabolism
What are CYP450 enzymes
or What is CYP3A4
Amount or fraction of drug administered dose reaching systemic circulation
What is bioavailability
Ends in an "ase"
Discovered the first antibiotic to treat syphilis
Who is Ehrlich
Paul Ehrlich
Patented and marketed under a proprietary name
What is a brand name
High protein binding limits amount of ______ drug to distribute to site of action
What is free drug
Process where drugs excreted in bile are reabsorbed from the intestine, prolonging half-life
What is entero-hepatic recirculation
Once receptor is bound, activates small intracellular signals
What are second messengers
Amendment to the FDCA requiring both safety and efficacy be proven prior to FDA approval.
What is the Kefauver-Harris Drug Amendments Act?
Phase of clinical trial where large populations are studied to confirm effectiveness and safety
What is phase III (3)
A drug that is inactive until metabolized into its active form in the body
What is a prodrug
Patient has this genetic variation in a specific group of liver enzymes that causes them to have a reduced response to a drug.
What is a rapid metabolizer
Gs-coupled receptor pathway activates this
What is cAMP