Lesson 4

Question 1

Adequate and well-controlled studies have failed to demonstrate a
risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters)

Answer 1

Pregnancy Category A

Question 2

drug failed to demonstrate fetal risk in animal studies, and there
are no adequate and well-controlled studies in pregnant women

Answer 2

Pregnancy Category B

Question 3

drug demonstrates fetal risk in animal studies, but there are no adequate and well-controlled; the potential benefit of using this drug during pregnancy may outweigh the potential risk

Answer 3

Pregnancy Category C

Question 4

drug demonstrates evidence of human fetal risk; however, the benefit of using this drug during pregnancy may outweigh the
potential risk

Answer 4

Pregnancy Category D

Question 5

both animal and human studies demonstrate fetal abnormalities
or adverse effects; the risk of using this drug during pregnancy
outweighs the benefit

Answer 5

Pregnancy Category X

Question 6

there is no available data to determine the drug’s teratogenic
effect; hence, the drug is not rated

Answer 6

NR

Question 7

the lowest drug concentration in the patient’s bloodstream

Answer 7

trough level

Question 8

indicates the margin of safety that exists between the
effective or therapeutic dose (ED) and the lethal or toxic dose (LD)

Answer 8

Therapeutic index (TI)

Question 9

the dose
that produces unwanted and possibly dangerous side effects

Answer 9

Lethal or toxic dose

Question 10

Is the median lethal dose which is defined as the dose causing mortality in
50 percent of the sample population

Answer 10

LD50

Question 11

is the median effective dose which is defined as the dose that causes 50
percent of a sample population to respond

Answer 11

ED50

Question 12

Are macromolecules that are involved in
various biochemical processes of the body. They are located on the cell surface membrane, in the cytoplasm, or the cell nucleus.

Answer 12

Receptors

Question 13

explains that drug molecule usually acts on receptor sites within the body, resulting in increased or decreased cellular activity, change in the permeability of cell membranes, or modification of cellular metabolism

Answer 13

Drug-Receptor interaction (Receptor Theory)

Question 14

The initiation of a response after the drug and the receptor binds

Answer 14

Intrinsic theory of drug action

Question 15

the intensity of drug
action is influenced by the amount of occupied receptor sites

Answer 15

Occupational theory of drug action

Question 16

considers the time when drug-receptor
interaction occurs

Answer 16

Rate theory

Question 17

explains that the percentage
of drug-occupied receptors determines the extent of the physiologic response

Answer 17

Law of mass action

Question 18

proposes that a receptor does not
necessarily need to be in an exact shape or configuration to bind with the active
substrate (drug). As the substrate binds with the receptor, the latter changes its
shape in conformation with the substrate’s shape (induced fit mechanism) to
permeate a better fit and cause a cellular response.

Answer 18

induced-fit theory

Question 19

binds with
the receptor to stimulate a
response

Answer 19

Agonist

Question 20

a drug that attaches
to the receptor but does not
cause a response

Answer 20

Antagonist

Question 21

compete with
agonists for receptor sites

Answer 21

Competitive antagonist

Question 22

bind
on other sites of the receptor or cell and inactivate it

Answer 22

non-competitive antagonists

Question 23

is a drug
that interacts with the receptor but produces only a slight chemical action and response

Answer 23

partial agonist

Question 24

explains that drugs can cause biological effects by interacting with the body’s enzyme systems, either by inhibiting or enhancing the action of the enzyme

Answer 24

cellular system theory

Question 25

refers to a drug’s ability to preferentially bind or attach to specific receptors in a particular organ or system

Answer 25

Selectivity

Question 26

release of drug

Answer 26

Liberation

Question 27

taken into the body

Answer 27

Absorbed

Question 28

moved into various tissues

Answer 28

Distributed

Question 29

changed into a form that can be eliminated from the
body

Answer 29

Metabolized

Question 30

the first step in determining the onset of action, rate of absorption,
availability, and the other processes for all drug products administered by all routes of
administration

Answer 30

Liberation

Question 31

the drug is released from its pharmaceutical or dosage
form (e.g., tablet, capsule, suppository, suspension, implant)

Answer 31

Liberation

Question 32

is the breakdown of the drug’s dosage form into chunks or
smaller granules

Answer 32

Disintegration

Question 33

is the further breakdown of drug granules into
smaller, fine particles

Answer 33

Disaggregation

Question 34

allows the drug molecules to be dispersed in
the gastric fluid, body cavities, or tissues before absorption

Answer 34

Dissolution

Question 35

drugs may be released in
any of these forms:

Answer 35

immediate
delayed
extended.

Question 36

The drug product is formulated to release the therapeutic drug without delay. In this
form, the drug reaches its site of action or goes into the bloodstream as quickly as
possible

Answer 36

immediate release

Question 37

means the drug product is formulated to release the
therapeutic drug sometime after it is taken

Answer 37

Delayed release

Question 38

the drug product is formulated to make the drug available over an extended period, thus reducing the dosage frequency.

Answer 38

extended-release

Question 39

Often produce a steadier plasma drug concentration with fewer side
effects. These products increase patient compliance
because of less frequent dosing

Answer 39

extended-release form

Question 40

the movement of the drug particles from the source of entry into the body (e.g., GI tract, mucus membrane, skin, body cavities, and tissues) to the
bloodstream.

Answer 40

Absorption

Question 41

The drug moves from an area of higher concentration to an area of lower concentration. This mechanism does not require energy or a
carrier protein to move the drug across biological membranes.

Answer 41

Passive diffusion

Question 42

This mechanism does not use energy. However, it needs
a transmembrane carrier protein (such as an enzyme) to facilitate the
movement of a large drug molecule from an area of higher concentration to
an area of lower concentration.

Answer 42

Facilitated diffusion

Question 43

carrier proteins are needed to facilitate drug absorption
across membranes. Drug molecules must closely resemble the structure of the carrier protein to facilitate absorption. Also, energy (ATP) is required to facilitate movement against a pressure gradient (from an area of lower concentration to an area of higher concentration)

Answer 43

Active transport

Question 44

this mechanism involves the absorption of large-sized drug particles through engulfment by the cell membrane. The drug is transported
into the cell by pinching the drug-filled vesicle. Vitamin B12 in the gut is
absorbed through this mechanism

Answer 44

Endocytosis

Question 45

occurs when the drug particle is delivered from the site of absorption to its site of action. When the active drug component is absorbed in the
systemic circulation, it has to reach its target cells to cause an effect.

Answer 45

Drug distribution

Question 46

the process of chemically altering the drug within the body by
enzymatic actions.

Answer 46

Metabolism/Biotransformation

Question 47

the process by which drugs and their metabolites are
removed from the body via excretory organs, including the kidneys (major excretory system), intestines, lungs, mammary glands, sweat glands, and salivary glands, and the skin.

Answer 47

Excretion or elimination