Deck 2: Veterinary Drug Development and Control

Question 1

Which regulatory agency develops new uses of existing pesticides?

A)USDA
B)EPA
C)FDA
D)DEA

Answer 1

EPA

Question 2

What test is done to determine the dosage at which a drug induces organ or tissue damage resulting in permanent injury or death?

A)Margin of safety
B)Therapeutic indexing
C)Systems-oriented screening
D)Toxicity evaluation

Answer 2

Toxicity evaluation

Question 3

When can preclinical studies begin?

A)Stage I
B)Stage II
C)Stage III
D)Stage IV

Answer 3

Stage II

Question 4

Which agency requires that all drugs be tested for adverse effects before approval?

A)USDA
B)EPA
C)FDA
D)DEA

Question 5

If a serious adverse reaction occurs on a ______ then the manufacturer will most likely terminate drug testing.

A)special test
B)short-term toxicity test
C)reproductive test
D)long-term test

Question 6

Which of the following statements is true?

A)Drugs that kill with a small dose need further evaluation.
B)Only drugs that are highly lethal need to include the lethal dose on their marketing materials.
C)The effective dose is the dose that produces the desired effect.
D)A dose can be called effective only if the amount of the test drug caused a defined effect in 75 percent of the animals.

Question 7

A dose can be called effective only if the amount of the test drug causes a defined effect in _____ of the animals that receive it.

A)10 percent
B)25 percent
C)50 percent
D)75 percent

Question 8

During which stage of drug development is a drug approved or rejected?

A)Stage I
B)Stage II
C)Stage III
D)Stage IV

Question 9

What is the lethal dose of Valium in mice?

A)720 mg/kg given orally
B)500 mg/kg given orally
C)2,000 mg/kg given orally
D)100 mg/kg given orally

Question 10

A greater therapeutic index is represented by a(n)_____ number.

A)equal
B)larger
C)smaller
D)zero

Question 11

How long are tests conducted before they can be labeled non-carcinogenic?

A)Three months
B)Six months
C)Three years
D)Six years

Question 12

When calculating the therapeutic index, what is used as the measure of toxicity?

A)The effective dose
B)The lethal dose
C)The margin of safety
D)Toxic evaluation

Question 13

How long does it take on average for testing before a new veterinary drug appears on the market?

A)One year
B)Three years
C)Five years
D)Seven years

Question 14

If a manufacturer wants to see if a drug causes cancerous tumors, which test would be conducted?

A)Carcinogenicity test
B)Special test
C)Reproductive test
D)Teratogenicity test

Question 15

What is another name for stability studies?

A)Shelf life studies
B)Clinical trials
C)Post-approval monitoring
D)Surveillance studies

Question 16

What percentage of the animals receiving a drug must die in order for researchers to identify the lethal dose?

A)10 percent
B)25 percent
C)50 percent
D)75 percent

Question 17

If there is a small difference between an effective dose and a lethal dose then there is a _____.

A)narrow therapeutic index
B)broad therapeutic index
C)narrow shelf life
D)broad shelf life

Question 18

What value is determined by comparing the drug's LD₅₀ and its ED₅₀?

A)Long-term toxicity
B)Systems-oriented screen
C)Chronic study
D)Therapeutic index

Question 19

What do systems-oriented screens test?

A)Toxicity
B)Physiological systems
C)Therapeutic indices
D)Margins of safety

Question 20

What is monitored during therapeutic drug therapy?

A)Temperature
B)Plasma levels
C)Blood pressure
D)Bone marrow

Question 21

After a drug is approved, is any further testing done?

A)No, once approved all testing is stopped.
B)No, because further testing may reveal adverse effects.
C)Yes, long-term toxicity tests continue for up to two years.
D)Yes, if the company so decides to continue testing.

Question 22

Who can report an adverse reaction to the FDA?

A)Veterinarians
B)Animal owners
C)Manufacturers
D)All of the choices are correct.

Question 23

When will the FDA approve a drug for general use even if it can cause birth defects?

A)If the risk to the fetus is so small in number that it is unlikely to occur
B)If the benefits of the drug are far greater than the risk to the fetus
C)If the manufacturer can demonstrate that the adverse effects no longer exist in certain breeds
D)If the therapeutic index has narrowed to such a number that the FDA is now comfortable with the risk

Question 24

When researchers are testing for fetal defects, they are testing for which adverse effect?

A)Carcinogenicity
B)Teratogenicity
C)Reproductivity
D)Toxicity

Question 25

If the LD₅₀ and ED₅₀ values are known for a given drug, how can you determine the therapeutic index?

A)By subtracting the LD₅₀ value by the ED₅₀ value
B)By adding the LD₅₀ value by the ED₅₀ value
C)By multiplying the LD₅₀ value by the ED₅₀ value
D)By dividing the LD₅₀ value by the ED₅₀ value