Week 1: Veterinary Drug Development Use & Prescribing Flashcards
What does NADA stand for and what does it consist of
New animal drug application
Four steps of drug approval
Is the drug working? Is it safe?
What does AMDUCA stand for and what does it do?
Animal medicinal drug use clarification act
Clears use for “extra label” applications
Important given small size of animal health market
What are the four steps of drug approval?
Preliminary studies Pre clinical studies Clinical trials (FDA approval) Post approval monitoring and reporting
What does the state boards of pharmacy do?
Most relevant for us
Makes sure rules are being followed, care about cleanliness, paperwork, inventory control, involved with monitoring prescriptions and frequency
What does the FDA do?
Food and Drug Administration
regulate feed animal drugs
What does the DEA do?
Drug Enforcement Administration
Regulates controlled drugs, based on addictive potential
What does the EPA do?
Environmental protection administration
Pesticides (like flea and tick drugs)
What does the USDA do?
United States Department of Agriculture
Biologics
Regulates substances made from a living source
vaccines and serums
What does APHIS stand for?
Animal plant health inspection service
What are some places you can get information about drugs?
Manufacturer’s package inserts
Veterinary Red Book Veterinary Physicians Desk Reference
VPB Veterinary Pharmaceuticals and Biological
What is the chemical name of a drug
the molecule
What is the generic name of a drug
Common name for the molecule
What are some characteristics of the patent holders trade name?
Patents run 17 years before expiration
Exclusive marketing rights may be less than 17 years
What does Rx mean?
Prescription
What does a “C” with Roman numerals indicate about a drug?
It is a controlled substance
What is a composition statement?
Describes the physical and chemical properties of the active drug
What is clinical pharmacology?
Modes and mechanisms of actions
What is ADME stand for when dealing with pharmacokinetics?
Administration
Distribution
Metabolism and bio transformation
Excretions pathways and rates