EXTRA-LABEL, COMPOUNDED, AND GENERIC DRUGS

Question 1

Define “New Animal Drug”

Answer 1

Drugs intended for animal other than man that is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in the labeling of the drug.

Question 2

Define “extra-label drugs”

Answer 2

Drug is used in a manner not in accordance with approved label directions.

Question 3

What animals are mostly in need of restrictions when administering extra label drugs?

Answer 3

Food animals.

Question 4

When are extra label drugs ONLY used in food animals?

Answer 4

ONLY FOR THERAPEUTIC PURPOSES (if an animal’s health is threatened or suffering)

NOT ALLOWED IN FEEDS

Question 5

Define “compounded drugs”

Answer 5

Manipulation of the drug beyond that stipulated on the label. (Usually mixing, combining, or altering ingredients to create a medication tailored to the needs of a patient)

Question 6

Are compounded drugs approved by the FDA?

Answer 6

Nope. Compounded drugs are basically adulteration of drugs.

Question 7

T or F
Generics or nonproprietary drugs may be pharmaceutically equivalent but may not be therapeutically equivalent.

Answer 7

T

Question 8

Define “Orange book”

Answer 8

Approved Drug Products With Therapeutic Equivalence Evaluations.

Question 9

What theory is being described?
The magnitude of pharmacodynamic is directly proportional to the number of receptors with which the drug interacts.

Answer 9

Drug-receptor Theory.

Question 10

What is the therapeutic range of drugs?

Answer 10

When the drug concentration is parallel to tissue concentration.

Below this, therapeutic faikure may result.

Above this, toxicity may result.

Question 11

What are the four drug movements that act on a drug simultaneously?

Answer 11

Absorption
Distribution
Metabolism
Excretion

Question 12

Science that mathematically describes the TIME course of plasma drug concentrations after administration of a dose. (The result of ADME)

Answer 12

Pharmacokinetics.

Question 13

Differentiate bulk flow from passive diffusion.

Answer 13

BF - movement of substances in bulk or masses down a pressure gradient.

PD - movement of molecules from high concentration to low concentration.

Both are passive processes

Question 14

4 methids by which drugs move.

Answer 14

Pinocytosis
Bulk flow
Passive diffusion
Carrier Mediated Transport

Question 15

What are xenobiotics?

Answer 15

Chemical to which an organism is exposed that are extrinsic to the normal metabolism of that organism.

Without metabolism, xenobiotics would reach toxic concentrations.

Question 16

The ratio concentration of a drug in two immiscible or slightly miscible phases.

Answer 16

Lipid/water partition coefficient.

Question 17

An equation that predicts the ratio of ionized and unionized drug.

Answer 17

Henderson Hasselbach

Question 18

The ratio of ionzed and nonionized forms of drugs depends on what constant?

This also measures the rate at which a drug is dissolved and broken down into its constituents.

Answer 18

Dissociation constant

Question 19

What happens to a drug if the environmental pH is similar to that of the dissociation constant?

ie. weak bases being ionized in alkaline pH. And weak acids being nonionized in acidic pH.

Answer 19

The more nonionized a drug is and will have higher chances of diffusingm

Question 20

What is the ratio of ionized and nonionized drugs to be considered diffusible?

Answer 20

Greater than or equal to 0.01

Question 21

All drugs need to pass a cell membrane to reach their receptor.

Answer 21

FALSE

Question 22

The most well known transport protein which belongs to the ATP-binding cassette superfamily of efflux transporters and has multiple drug resistance.

Answer 22

P-glycoprotein

Question 23

Define first pass effect

Answer 23

Phemomenon in which a drug is metabolized in a specific location in a body that results in the reduced concentration of the active drug before reaching its site of action.

Question 24

What drug penetrates the skin slowly compared with their rate of absorption to other body membranes?

Lilid-soluble or lipid-insoluble drugs

Answer 24

Lipid-insoluble drugs.

Question 25

Why is stratum corneum being disrupted during the application of drugs in the skin?

Answer 25

To enhance drug absorption

Question 26

Why is dimethyl sulfoxide applied to the skin before the administration of topical drugs?

Answer 26

To enhance drug absorption and penetration

Question 27

What is the effective barrier of the skin that prevents or hinder a topical drug’s absorption?

Answer 27

Stratum corneum

Question 28

Why are volatile and gasseous anesthetics diffuse instantaneously? (Have instantaneous effect)

Answer 28

Because of their small molecules and relatively high water-lipid partition coefficients.

Question 29

The rate of blood flow affects the rate of capillary wall

Answer 29

False.

Question 30

What causes the rapid rate of diffusion of drugs that pass through the capillary walls?

Answer 30

The fenestration of the capillary. And because capillaries are not affected by the blood flow.