Block 5 Flashcards
Veterinary Drugs
Products that are use to diagnose, cure, mitigate, treat, or prevent disease.
Product
A specific formulation of an active substance that has a claim for efficacy and safety at a certain dose
Active substance vs Product
Active substance is the individual part of a drug that has pharmaceutical properties, while a product is the combination between the active substance + inactive ingredients (coloring agents, preservatives).
T/F: Active substances (on its own) may have a completely different safety and efficacy profile than the product as a whole
True
Define efficacy for pain
Decreased lameness, decreased vocalization, change in facial expressions, improved mobility
Define efficacy for parasites
Decreased worms, decreased eggs in feces
Parasiticides legally have to be >___% effective, other drugs need “________” evidence
90%, “substantial evidence”
Substantial evidence
A statistical P value that is LESS than 0.05
Target animal safety studies (TAS)
Studies performed with the product (not just active ingredient) in the animals it plans to be used on
Animal class safety study
Narrowing down testing to certain classes of animals (like breed)
Label data is developed from… (2)
1) safety studies (controlled studies with beagles)
2) adverse events during field studies and post marketing
Maximum safe dose
The most of a drug you can give without causing adverse effects
Minimum effective dose
The least amount of a drug you can give befire it becomes ineffective
2 different types of dosing
Exact dose and Dose band
Exact dose
A drug that has a specific and precise quantity that needs to be administered according to weight
