Week 1 Intro Flashcards
What is primarily occuring in phase 1 trials
20-100 participants, asking about pharmaxokinetics to see if its safe and how the body metabolizes it
What occurs primarily in phase 2 trials
Does this drug work to treat patients (find dosing to treat patients)
What occurs in phase 3 clinical trials
Asking if it works, use double blind RCT with selective screening, 1000-6000.
What occurs in phase 4
marketing, the drug is on the market to be perscribed.
If a drug does not have a name yet, what stages is it in?
1 or 2 probably
Labeled vs off-label
Labeled- drug marketed for the indication, approved through FDA process (i.e. metformin for DM2)
off label- Drug has not gone through FDA process for that disease (i.e metformin to treat PCOS)
What are orphan drugs
Treat rare condition (<200k people in the USA) that are otherwise cost prohibitive, so companies are given financial incentives
What is on the PI vs Medication gudie
Document providing information about the drug you use, oriented to medical professionals. Reviewed by FDA.
Medication guides are for consumer and are easier to understand
Black box warning vs contraindication
Black box warning is something to be cautious about/aware of when prescribing
Contraindication= absolutely do not give medication with the disorder
mcg
microgram
cap
capsule
elix
elixir
ODT
orally disintegrating tab
Supp
suppository
Tab
tablet
gtt
Drip (i.e. Nitroglycerine drip)
IM
Intramuscular
SC/SQ
Subcutaneous
IV
Intravenous
IVPB
IV infused over short duration
Inh
inhaled
neb
nebulized
PO
by mouth
PR
By rectum
