Veterinary Drugs

Question 1

What can be learned from the drug label

Answer 1

Estimate safe dose/ effective dose

Estimate how close the safe dose is to the effective dose

Adverse effects

Risks regarding age, weight, reproductive status

Question 2

Veterinary Drug

Answer 2

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

Question 3

Why would a product with lower efficacy be registered?

Answer 3

Different measurements

Different mode of action

Better safety profile

Question 4

What is included on the product label

Answer 4

Indication

Dose and administration

Safety

Adverse reactions

Warnings/ Disposal

Expiry or Stability

Question 5

Animal Class Safety Study

Answer 5

Youngest age group for the product

Reproductive safety

Special cases - specific breeds

Question 6

T/F: Efficacy is disease dependent

Answer 6

True

_______________________

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

Question 7

T/F: Efficacy level is disease dependent

Answer 7

True

________________________

Dose should be the minimum effective

Question 8

The (lowest/highest) weight in a dose band is used to estimate the minimum effective dose

Answer 8

​The (lowest/highest) weight in a dose band is used to estimate the minimum effective dose

Question 9

The US FDA is responsible for monitoring what of veterinary drugs

Answer 9

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

Question 10

Where are reliable sources to get information on veterinary drugs

Answer 10

FDA Freedom of Information Act (FOIA) drug summaries

Question 11

Dose Band

Answer 11

One quantity for a range of body weight

Question 12

What is incorporated into Target Animal Safety (TAS)

Answer 12

Tolerance Studies

Animal Class Safety Study

Pharmacokinetics - sometimes

Safety and Efficacy in other test subjects

Field Study

Pharmacovigilance

Question 13

Veterinary drugs are approved by

Answer 13

US Food and Drug Administration (FDA)

Question 14

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

Answer 14

Lowest dose required for effect

Question 15

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

Answer 15

False

Question 16

Exact Dose

Answer 16

One quantity of medication per kg of body weight

Question 17

Efficacy Studies

Answer 17

In vitro studies

Bioequivalence studies

Dose- Titration / Dose- Determination

Dose- confirmation

Question 18

Tolerance Studies

Answer 18

Normal, healthy laboratory beagles

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

Topicals tested topically and orally

Maximum recommended dose / target dose

Question 19

Label data is developed from

Answer 19

Safety studies

Adverse reactions that occur during efficacy and field studies

Adverse events that occur post-marketing

Question 20

The (lowest/highest) weight in a dose band is used to estimate the maximum safe dose

Answer 20

The (lowest/highest) weight in a dose band is used to estimate the maximum safe dose

Question 21

Product label is monitored and negotiated between

Answer 21

the FDA and product Company

Question 22

What is determined from dose-confirmation efficacy studies

Answer 22

Efficacy for each claim in each animal species for which the product will be used or proof of limiting species