Veterinary Drugs Flashcards
What can be learned from the drug label
Estimate safe dose/ effective dose
Estimate how close the safe dose is to the effective dose
Adverse effects
Risks regarding age, weight, reproductive status
Veterinary Drug
Products that are used to diagnose, culture, mitigate, treat or prevent diseases
Why would a product with lower efficacy be registered?
Different measurements
Different mode of action
Better safety profile
What is included on the product label
Indication
Dose and administration
Safety
Adverse reactions
Warnings/ Disposal
Expiry or Stability
Animal Class Safety Study
Youngest age group for the product
Reproductive safety
Special cases - specific breeds
T/F: Efficacy is disease dependent
True
_______________________
For each indication, the product at the planned labeled dose must be shown effective
T/F: Efficacy level is disease dependent
True
________________________
Dose should be the minimum effective
The (lowest/highest) weight in a dose band is used to estimate the minimum effective dose
The (lowest/highest) weight in a dose band is used to estimate the minimum effective dose
The US FDA is responsible for monitoring what of veterinary drugs
Safety and Effectiveness for intended use
Methods, facillities and control used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity
Where are reliable sources to get information on veterinary drugs
FDA Freedom of Information Act (FOIA) drug summaries
Dose Band
One quantity for a range of body weight
What is incorporated into Target Animal Safety (TAS)
Tolerance Studies
Animal Class Safety Study
Pharmacokinetics - sometimes
Safety and Efficacy in other test subjects
Field Study
Pharmacovigilance
Veterinary drugs are approved by
US Food and Drug Administration (FDA)
What is determined from dose-titration/ dose-determination efficacy studies
Lowest dose required for effect
T/F- Ectoparasitics, Teat dips, Cleaning agents, vaccines, vitamins and supplements are considered veterinary drugs
False
Exact Dose
One quantity of medication per kg of body weight
Efficacy Studies
In vitro studies
Bioequivalence studies
Dose- Titration / Dose- Determination
Dose- confirmation
Tolerance Studies
Normal, healthy laboratory beagles
1x, 3x, 5x dose and length of treatment
Topicals tested topically and orally
Maximum recommended dose / target dose
Label data is developed from
Safety studies
Adverse reactions that occur during efficacy and field studies
Adverse events that occur post-marketing
The (lowest/highest) weight in a dose band is used to estimate the maximum safe dose
The (lowest/highest) weight in a dose band is used to estimate the maximum safe dose
Product label is monitored and negotiated between
the FDA and product Company
What is determined from dose-confirmation efficacy studies
Efficacy for each claim in each animal species for which the product will be used or proof of limiting species
