Veterinary Drugs Flashcards Preview

RUSVM Pharmacology > Veterinary Drugs > Flashcards

Flashcards in Veterinary Drugs Deck (22):
1

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

2

Veterinary Drug

Products that are used to diagnose, culture, mitigate, treat or prevent diseases

3

Why would a product with lower efficacy be registered?

Different measurements

Different mode of action

Better safety profile

4

What is included on the product label

Indication

Dose and administration

Safety

Adverse reactions

Warnings/ Disposal

Expiry or Stability

5

Animal Class Safety Study

Youngest age group for the product

Reproductive safety

Special cases - specific breeds

6

T/F: Efficacy is disease dependent

True

_______________________

For each indication, the product at the planned labeled dose must be shown effective

7

T/F: Efficacy level is disease dependent

True

________________________

Dose should be the minimum effective

8

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

9

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

10

Where are reliable sources to get information on veterinary drugs

FDA Freedom of Information Act (FOIA) drug summaries

11

Dose Band

One quantity for a range of body weight

12

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

13

Veterinary drugs are approved by

US Food and Drug Administration (FDA)

14

What is determined from dose-titration/ dose-determination efficacy studies

Lowest dose required for effect

15

T/F- Ectoparasitics, Teat dips, Cleaning agents, vaccines, vitamins and supplements are considered veterinary drugs

False

16

Exact Dose

One quantity of medication per kg of body weight

17

Efficacy Studies

In vitro studies

Bioequivalence studies

Dose- Titration / Dose- Determination

Dose- confirmation

18

Tolerance Studies

Normal, healthy laboratory beagles

1x, 3x, 5x dose and length of treatment

Topicals tested topically and orally

Maximum recommended dose / target dose

19

Label data is developed from

Safety studies

Adverse reactions that occur during efficacy and field studies

Adverse events that occur post-marketing

 

20

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

21

Product label is monitored and negotiated between

the FDA and product Company

22

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