Intro Pt 3 - not covered Flashcards
preclinical testing
1-3 years
animal trials
get dosage and toxicity
pharmacokinetics and dynamics
Human/clinical trials
6-8 years
phases 1-3
1. safety
2. work in pts?
3. work in double blind?
phase 4 is post marketing surveillance and ongoing
orphan drug program
drugs to treat rare conditions
expedited process to treat rare diseases
addt funding
route of administration
path by which drug is brought into contact with the body
how route is decided
drug properties
sire of desired action (local/systemic)
rate of absoprtion
digestion effect
routine/emergency
accuracy of dose
pt condition/cx/vomiting
routes of administration list
Enteral:
oral
sublingual
rectal
Parenteral:
inhalation
injection
topical
also:
intraperitoneal
intraarticular
intraspinal
epidural
intracardiac
inhalation
topical
transdermal
first pass metabolism
oral route drugs are absorbed through the stomach and sent to the portal vein for filtration in the liver
drug is metabolized by liver enzymes before entering systemic circulation
oral route drug formulations
tablet
enteric coated tablet
capsule
mixture
extended release tablet
parenteral
administered not through the mouth/digestive system
parenteral route of administration
intramuscular
subcutaneous
intravenous
intradermal
intrathecal
administer into spinal cord
spinal anesthesia, pain relief, chemo
epidural route
injection into epidural space above dura before CSF
local anesthetics
local route
skin - ointments, sprays, etc
inuction - rub on skin
mucous membranes - drops, mouth wash, etc