Midterm Flashcards
3 different types of drug names
Chemical
Trade (brand)
Generic
Generic name starts with a
Lowercase letter
Before any drug is marketed it is given a ____ that becomes the “official” name for the drug
Generic name
Brand name starts with a
Upper case letter
acetaminophen is a trade name, what is an example of its generic name
Tylenol
FDA requires the active ingredient of the generic product to ____ at the same rate as the trade name product
Enter the bloodstream at the same rate
Generic name is generally ___ than brand name items
Cheaper
What does chemically equivalent mean
2 formulations of a drug meet the chemical and physical standards established by regulatory agencies
What does biologically equivalent mean
2 formulations of a drug produce similar concentrations of the drug in the blood and tissues
Therapeutically equivalent means
2 formulations of a drug have an equal therapeutic effect
For medications to be FDA approved it needs to be
Biologically equivalent and therapeutically equivalent
FDA determines?
Which drugs can be sold by prescriptions and OTC
Who regulates the labelling and advertising of prescription drugs
FDA
How long does it take for a new drug to be available on pharmacy shelves
12 years
Animal studies usually begin by measuring what?
Acute and chronic toxicity
Phase I clinical trials refers to small and then increasing doses administered to?
A limited number of healthy human volunteers
Phase I of clinical studies determines ?
Biologic effects
Metabolism
Safe dose range in humans
Toxic effects of the drigs
In phase II of clinical studies a larger group of humans are given the drug. What is reported by the FDA during this phase?
Adverse reactions
Phase 3 of clinical trials involves a large number of patients who have?
The condition for which the drug is indicated for
In phase III of clinical studies what must be demonstrated?
What is determined?
Safety and efficacy must be demonstrated
Dosage is determined
Phase 4 of clinical studies involves?
(Drug is now approved at this point)
Post marketing surveillance
-toxicity that occurs in pts taking the drug after it is released is recorded
Schedule II-IV drugs require a
Prescription
What schedule of drugs must be types or written in one or indelible ink
Schedule II
What schedule of drug prescriptions CANNOT be phoned to pharmacist
Schedule II