z. Exam 1 Concepts Flashcards
Yearly Process for FDA Approval
0-4 Years: Computer models and animal studies
4: Healthy human volunteers (male, young, no previous medical conditions)
6ish: Target population
9: Market, expanded to elderly, liver/kidney
20 years: Patents and generics
Lab Testing in Vitro
In test tubes or dishes
Lab Testing in Vivo
On living organisms
Vitro: the ‘t’ is for trial or laboratory setting
Medication Death: Misfeasance
Negligence - wrong drug or dose given
“missed the mark”
Medication Death: Nonfeasance
Omission- not giving prescribed medication
Medication Death: Malfeasance
Giving the correct dose but through wrong route
Pharmacogenetics
Variations of the predicted drug response due to patients individual genetic factors
Biologic Variations (Asian/African American)
Asian: Decreased Response to drugs r/t CTP2D6 enzyme
AA: Respond poorly to anti-hypertensives
Disintegration
Stage 1 in physically breaking down a medication
Dissolution
Drug becomes a solution that can cross biologic membrane and available for the body absorb/use
Absorption
Movement of drug particles from the GI tract to the body fluids
Distribution
Drug becomes available to body fluids and tissue
Metabolism
Body (individual cells) inactivates the drug
Excretion
How the body gets rid of the drug (kidney/liver)
Effects on Absorption
- Drug forms, route, GI mucosa’s, food, metabolism
- Absorption is reduced if there are fewer villi in small intestine (r/t disease or surgery)
First pass effect
Medication passes through the liver before it reaches systemic circulation
Bioavailability
What % of the dose reaches the systemic circulation
IV - 100%
IM/SC - 75%-100%
PO - 5%-100%
Rectal - 30% - 100%
Blood brain barrier and its effect on distribution
Only lipid soluble medications are able to pass, making treatment for brain injuries challenging
Drug Classifications for Pregnancy
A, B, C, D, X
Where X is never
Ex Thalidamide
Liver Disease and the effects on metabolism
Since most medications are metabolized by the liver, a damaged liver extends the half life and could lead to toxicity
Main route of excretion
Kidneys
Others: Liver, feces, lungs, saliva, breast milk, sweat
Effects of GFR on excretion
A decreased GFR impairs drug excretion and can lead to accumulation of the drug in the system
Pharmacodynamics
Study of biochemical and physiological effects of drugs (what the drug does to the body)
Pharmacodynamics - Primary effect
Desirable and what the medication is supposed to do