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Pharmaceutics Exam 1

Total questions: 120

Worksheet time: 1hrs 9mins

Name
Class
Date
1.

Pick a best definition for a drug.

a)

Medication we can only get from a pharmacy that is prescribed by a doctor

b)

Any product that produces a cure in a person

c)

Any product that is approved for use in treating a diagnosis, producing a cure, treatment and/or preventing a disease; and intended to affect the function of the body

d)

A chemical substance a person takes; this may be a drug of wine, a glass of juice or cough sedative

2.

Dosage form is the type of physical product of a drug, mixed with inactive components and active ingredients.

a)

true

b)

false

3.

Select all or any that are possible dosage forms.

a)

tablets

b)

suppositories

c)

solutions

d)

aerosols

4.

What are ways pharmaceutical exicipents work to make a drug more acceptable?

a)

physical appearance

b)

texture of the drug

c)

taste and odor of the drug

d)

cost of the drug

5.

What are the key attributes of pharmaceutical expicients?

a)

safety, quality, functionality

b)

safety, quantity, texture

c)

safety, size, appearance

d)

size, shape, texture

6.

The systematic chemical name is...

a)

the IUPAC

b)

the Brand name

c)

the Generic name

7.

The generic name...

a)

issued only for a single chemical

b)

issued for a single chemical or mixture of chemicals

c)

scientific name

8.

What is the difference between a comatose and ambulatory patient?

a)

ambulatory can not walk and are sitting in the ER waiting for help, very sickly patient

b)

comatose is a patient that is at home going through hospice

c)

comatose is a patient in a state of unconsciousness

d)

ambulatory îs a patient who is able to walk around

9.

Select the reason(s) to why patients need a dosage form.

a)

provides convenience and aesthetics

b)

instant delivery of drugs directly to blood circulation

c)

provides liquid preparation of drugs that are unstable and insoluble for a desire solvent

d)

provide time or site-specific action

10.

Drug delivery systems are specialized dosage forms with specific...

a)

release rate and release site

b)

action site

c)

receptor site and release rate

11.

Which dosage form characteristic affect bioavailability of drug?

a)

disintegration/ dissolution rate

b)

solid-state form

c)

storage conditions

d)

particle size

12.

What physiologic factors and patient characteristic affect bioavailability of a drug?

a)

drug metabolism

b)

gastric emptying time/ intestinal timing

c)

fluids in system

d)

gastrointestinal pH

e)

drugs effects, food, fed or fasting status

13.

Select advantage(s) of oral RoA.

a)

wide range of pH availability for absorption through GI tract

b)

convenient

c)

non-invasive

d)

most natural compared to other routes

14.

Select the classification(s) of drug forms.

a)

physical state

b)

intended action

c)

route

d)

duration

15.

Which classification of dosage forms is that of physical state?

a)

solid, semi-solid, liquids, disperse systems

b)

system and local

c)

enteral and paternal

d)

fast acting and long acting

16.

Which classification(s) of dosage forms is that of intended action?

a)

solid, semi-solid, liquids, disperse system

b)

systemic and local

c)

enteral and paternal

d)

fast acting and long acting

17.

Which classification of dosage forms are that of RoA?

a)

solids and semi-solids

b)

systemic and local

c)

enteral and paternal

d)

fast acting and long acting

18.

Which classification of dosage forms is related to duration of action?

a)

fast acting and long acting

b)

enteral and parenteral

c)

system and local

d)

solid, semi-sold, liquids, and disperse systems

19.

Select enteral route(s).

a)

oral, rectal, sublingual

b)

oral, rectal, nasal

c)

nasal, otic, ocular

d)

pulmonary, oral, rectal

20.

What is the difference between enteral RoA and parenteral RoA?

a)

enteral RoA the medication flows through the intestine before getting to the intended site

b)

parenteral RoA the medication avoids the intestinal route

c)

enteral RoA and parenteral RoA flow opposite routes and are excreted untimely

d)

parental RoA flows through the intestinal tract and enteral RoA flow past the intestinal RoA

21.

Drugs work by:

Having active ingredients (API) in a dosage form, RoA, absorption of drug into circulation, then reaching drug target.

a)

True

b)

False

22.

Bioavailability is the rate and extent to which a drug is absorbed from a dosage form and become available at the site of action.

a)

True

b)

False

23.

What flow will oral administration take?

a)

mouth, GI tract, circulatory system, target, excreted

b)

GI tract, circulatory system, target, excreted

c)

mouth, GI tract, target, excreted

d)

mouth, GI tract, circulatory system, excreted

24.

The acting of a drug, fast or long, is the process of which classification of dosage forms?

a)

physical state

b)

duration of action

c)

intended action

d)

route of administration

25.

Drugs act systemically or locally, which classification of dosage forms is this?

a)

intended action

b)

duration of action

c)

route of administration

d)

physical state

26.

Which oral dosage form has the highest bioavailability?

a)

solution

b)

coated tablets

c)

suspension

d)

capsule

27.

Which oral dosage form has the lowest bioavailability?

a)

solution

b)

coated tablets

c)

uncoated tablets

d)

capsules

28.

True or False.

Variety of dosage forms can be designed for enteral and parenteral routes of administration.

a)

True

b)

False

29.

The route of IV injections:

a)

Injected into the circulatory system

b)

From the circulatory system can be distributed to GI tract and tissue

c)

Drug reach intended site

d)

Drug metabolizes and excreted

30.

IM and SC injection route:

a)

Injected into the tissues

b)

Distributes to the circulatory system and GI tract

c)

Drug metabolize and excreted

d)

Into tissues, metabolite, excreted

31.

Which correctly defines bioavailable dose?

a)

—The rate and extent to which a drug substance is absorbed from a drug product (a dosage form) and becomes available at the site of drug action

b)

—The fraction of an administered dose that reaches the systemic circulation in the unchanged form

c)

—The ability of a drug to reach the systemic circulation and also be distributed to tissues and GI tract

d)

The absorption from a drug product (a dosage form) and becomes available at the site of drug action

32.

Metabolism is also called...

a)

biotransformation

b)

detoxification

c)

inactivation

d)

biomolecules

33.

Metabolism involves...

a)

the chemical changes to drugs within the body

b)

the physical changes to drugs within the body

c)

the overall mechanism of drugs within the body

34.

First pass effect means

a)

drug is only metbolized in liver

b)

drug is only metabolize in gut

c)

drug is may metabolize in liver and Gi

d)

drug makes a pass and goes into the circulation

35.

Non-first pass means

a)

drug does not metabolize in liver

b)

drug makes its way to site

c)

bioavailability is variable

36.

Can drugs be reabsorbed?

a)

Yes

b)

No

37.

Define adult dose.

a)

is the amount of drug that usually produces the medicinal effect in the adult patient

b)

is the amount that that usually produces the medicinal effect in the infant or child patient

c)

is a dose given at the beginning of treatment to start getting the effect of a drug

d)

is the amount that that usually produces the medicinal effect in any patient

38.

Define pediatric dose.

a)

is the amount of drug that usually produces the medicinal effect in the adult patient

b)

is the amount that that usually produces the medicinal effect in the infant or child patient

c)

is the amount that that usually produces the medicinal effect in any patient

39.

Define dosage regimen.

a)

is the prescribed schedule of dosing

b)

is a larger-than-usual initial dose

c)

are similar in amount to usual doses and are used to sustain the desired drug blood levels

d)

is a dose given at the beginning of treatment to start getting the effect of a drug

40.

Define initial dose.

a)

is a dose given at the beginning of treatment to start getting the effect of a drug

b)

larger than usual dose

c)

the lowest concentration dose

d)

the amount the produces intensity

41.

Define loading dose.

a)

is a dose given at the beginning of treatment to start getting the effect of a drug

b)

a larger than usual initial dose

c)

the prescribed schedule of dosing

42.

Is the ratio (TD50/ED50) between a drug's median toxic dose & its median effective dose -

a)

therapeutic dose

b)

median toxic dose (TD)

c)

median effective dose (ED)

d)

minimum toxic concentration (MTC)

43.

Is the amount that produces toxic effects in 5o% of the people -

a)

median toxic dose (TD)

b)

median effective dose (ED)

c)

therapeutic index

d)

minimum effective concentration (MEC)

44.

Which defines minimum toxic concentration (MTC)?

a)

is the minimum serum concentration of the drug that can produce the desired therapeutic effect

b)

is the lowest concentration of an antimicrobial drug that prevents visible growth of a microorganism after incubation with media.

c)

is the base level of blood serum concentration that produces dose-related toxic effects

d)

is the amount that produces toxic effects in 50% of the individuals

45.

Define maintenance dose.

a)

are similar in amount to usual doses and are used to sustain the desired drug blood levels

b)

is a larger-than-usual initial dose

c)

is a dose given at the beginning of treatment to start getting the effect of a drug

d)

is the lowest concentration of an antimicrobial drug that prevents visible growth of a microorganism after incubation with media.

46.

Is the base level of blood serum concentration that produces dose related toxic efects -

a)

minimum toxic concentration (MTC)

b)

median effect dose (ED)

c)

median toxic dose (TD)

d)

minimum inhibitory concentration (MIC)

47.

What are sources for new drugs?

a)

plants

b)

synthesized in labs

c)

biotechnology

d)

universities

48.

What are the benefits from drugs being synthesized in labs?

a)

having high purity

b)

less expensive

c)

more expensive

d)

large production

49.

How are drugs discovered?

a)

by a medical staff

b)

from a disease

c)

from signs/symptoms

d)

based on the receptor type

e)

from historians

50.

Select which definition is a goal drug.

a)

to find an active ingredients or modify an existing active ingredients

b)

prototype of the drug that has desire activity but also many undesirable characteristics

c)

compound that is worthy of extensive biological, pharmacological, and animal testing

d)

is required to have a metabolic transformation after administration to produce desire effect of active compound

51.

Select the definition of lead compound.

a)

is a prototype of the drug that has desire activity but also many undesirable characteristics

b)

to find an active ingredient or modify an existing active ingredient to form a new drug

c)

is a compound that is worthy of extensive biological, pharmacological, and animal testing

d)

is required to have a metabolic transformation after administration to produce desire effect of active compound

52.

Which is a great definition of drug candidate?

a)

is required to have a metabolic transformation after administration to produce desire effect of active compound

b)

is a compound that is worthy of extensive biological, pharmacological, and animal testing

c)

is a prototype of the drug that has desire activity but also many undesirable characteristics

d)

to find an active ingredient or modify an existing active ingredient to form a new drug

53.

Define a prodrug.

a)

to find an active ingredient or modify an existing active ingredient to form a new drug

b)

is required to have a metabolic transformation after administration to produce desire effect of active compound

c)

is a compound that is worthy of extensive biological, pharmacological, and animal testing

d)

is a prototype of the drug that has desire activity but also many undesirable characteristics

54.

Which is the most desirable RoA?

a)

oral

b)

IV injection

c)

rectal

d)

topical

55.

Select any lead discovery methods.

a)

random screening

b)

metabolism studies

c)

clinical observation

d)

rational design

e)

high throughput screening

56.

Which lead discovery method identifies the cause of the disease and used that a the substrate or known drug?

a)

rational design

b)

clinical observation

c)

metabolism studies

d)

high throughput screening

57.

Which lead discovery method is used to screen for same or other potential activities?

a)

metabolism studies

b)

clinical observation

c)

rational design

d)

random screening

58.

Scientist bring together tractable targets and chemical to identify the lead compound

a)

HTS

b)

rational drug

c)

clinical observation

d)

metabolism studies

59.

What does the lead optimization process result in?

a)

drug

b)

drug candidate

c)

approved drug

d)

lead compound

60.

The lead optimization process

a)

test the activity

b)

test the potency

c)

test the activity and potency

61.

IC50 is the concentration at 50% of the drug will inhibit

a)

true

b)

false

62.

EC50 is the 50% concentration to produce effectiness.

a)

True

b)

False

63.

Which is the definition fo activity of a drug?

a)

biological effect produced

b)

is the strength of the biological effect produced

c)

neither

d)

both

64.

Which is the best definition of potency of a drug?

a)

biological effect produced

b)

strength of biological effect produced

c)

both

d)

neither

65.

Which is Phase 1 of clinical trials?

a)

testing in humans for the first time, asses the risk vs the benefits, determine the metabolic activity along with side effects

b)

evaluates pharmacological effects and test the efficacy of the drug, identifies the dosage and response characteristics of drug

c)

evaluates the overall benefit-risk relationship which proves information of efficacy and safety of drug

d)

continual data collecting, where long-term effects are discovered, product defects are reported and determined

66.

How many phases are clinical trials split into?

a)

one

b)

two

c)

three

d)

none

67.

The preclinical studies test in humans.

a)

False

b)

True

68.

Phase 2 clinical trials..

a)

testing in humans for the first time, asses the risk vs the benefits, determine the metabolic activity along with side effects

b)

evaluates the overall benefit-risk relationship which proves information of efficacy and safety of drug

c)

evaluates pharmacological effects and test the efficacy of the drug, identifies the dosage and response characteristics of drug

d)

continual data collecting, where long-term effects are discovered, product defects are reported and determined

69.

Which event partake in Phase 3 of clinical trials?

a)

continual data collecting, where long-term effects are discovered, product defects are reported and determined

b)

evaluates the overall benefit-risk relationship which proves information of efficacy and safety of drug

c)

evaluates pharmacological effects and test the efficacy of the drug, identifies the dosage and response characteristics of drug

d)

testing in humans for the first time, asses the risk vs the benefits, determine the metabolic activity along with side effects

70.

In new drug development process.

This is the are part of the drug discovery stage where chemistry, physical properties and biologic activity are assessed of a potential lead compound as safe and effective therapeutical.

a)

preclinical studies

b)

clinical trials

c)

phase 1

d)

post marketing

71.

This phase is checking the safety in humans.

a)

phase 1

b)

phase 2

c)

phase 3

d)

phase 4

72.

This phase test the effectiveness of the drug.

a)

phase 1

b)

phase 2

c)

phase 3

d)

phase 4

73.

This phase checks for the safety, effectiveness and dosage.

a)

phase 1

b)

phase 2

c)

phase 3

d)

phase 4

74.

This phase determines the metabolic activity and side effects of a dose.

a)

phase 1

b)

phase 2

c)

phase 3

d)

phase 4

75.

This phase evaluates test the ability to produce the desire effect of the drug, the efficacy.

a)

phase 1

b)

phase 2

c)

phase 3

d)

phase 4

76.

This phase evaluates the overall benefit to risk of the drug.

a)

phase 2

b)

phase 3

c)

phase 1

d)

none

77.

When will IND be submitted in drug approval process.

a)

before clinical trials

b)

after clinical trials

c)

after NDA

d)

after postmarking

78.

When will NDA be submitted in the drug approval process?

a)

before postmarking, after clinical trials

b)

after clinical trial, before preclinical trials

c)

after preclinical trials, before IND

d)

after IND and after clinical trials

79.

The name of IND.

a)

Investigation New Drug Application

b)

New Drug Application

c)

Abbreviated New Drug Application

d)

Biologic License Application

80.

The name of NDA.

a)

New Drug Application

b)

Investigational New Drug Application

c)

Abbreviated New Drug Application

d)

Biologic License Application

81.

Which drug application is used to gain approval for generic drugs.

a)

NADA

b)

NDA

c)

ANDA

d)

IND

82.

This drug application is required for biologic, vaccines and human blood products.

a)

BLA

b)

ANDA

c)

NDA

d)

IND

83.

This application seeks approval to market a new product after preclinical and clinical studies are completed.

a)

NDA

b)

IND

c)

ANDA

d)

BLA

84.

This application must be submitted for a new drug to begin testing in humans.

a)

NDA

b)

IND

c)

ANDA

d)

BLA

85.

Which application matches the goal to protect the right and safety of human and to ensure the investigation is coherent and sound.

a)

NDA

b)

IND

c)

ANDA

d)

BLA

86.

Which application goal is to gain marketing permission of a new drug?

a)

IND

b)

NDA

c)

ANDA

d)

BLA

87.

This application establishing bioequivalence of generic and original drug.

a)

ANDA

b)

NDA

c)

IND

d)

BLA

88.

No preclinical or clinical study necessary for this application.

a)

ANDA

b)

NDA

c)

IND

d)

BLA

89.

When is a clinical hold place on a IND application of a drug?

a)

unreasonable risk are show

b)

unqualified investigators are reviewed

c)

misleading information from investigators

d)

not enough information is established

90.

What is the process for an orphan drug?

a)

to be used for a rare condition

b)

can be submitted at anytime

c)

only able to submit after trials are completed

d)

other sources have failed

91.

A full hold is placed on a new drug when all clinical studies must be resolved.

a)

True

b)

False

92.

(a)   is to find an active ingredient or modify existing active ingredient to form a new drug

93.

Best definition of prodrug.

a)

a compound that requires metabolic transformation after it is administrated to produce desire pharmacologically active compound

b)

an active drug

c)

do not need to metabolize because they are prodrug, so produce an desire effect

94.

Select the rationale for preformulation studies.

a)

the process is doing before learning

b)

the process of completely a new drug and putting the shelf

c)

the process of investigating properties ingredients before forming the drug

95.

Select the goals of preformulation

a)

to establish physical characteristics

b)

to establish necessary parameters

c)

to establish the compatibility

d)

to determine the stability

e)

all are correct

96.

What is the principle of thermal analysis?

a)

the change in thermal energy as a function of temperature

b)

the change in all properties of a drug

c)

to purpose a melting form of a drug

97.

Thermal analysis is studying the properties of material as they change with temperature.

a)

True

b)

False

98.

Differential Scanning Calorimetry (DSC) is the difference of heat required to increase temperature of a sample.

a)

true

b)

false

99.

When a molecules melts -

a)

endothermic

b)

exothermic

c)

moves in a positive (upward) direction

d)

moves in a negative (downward) direction

100.

When a molecule crystallizes -

a)

it's endothermic

b)

it's exothermic

c)

its moves in a positive direction

d)

moves in a negative direction

101.

What does (TGA) Thermogravimetric Analysis?

a)

tells the loss/gain of weight of compound when the temperature change

b)

measures the changes of properties of product

c)

measure the temperature changes of compound based on loss/gain of weight

102.

(TMA) Thermomechanical Analysis measures

a)

the change of dimensions/ mechanical properties of a sample against the temperature

b)

measure changes without any temperature acting on it

c)

measures the loss/gain of weight due to temperature

103.

The purer the compound, the (a)   the MP range

104.

The purer the compound, the (a)   the MP.

105.

How is melting point (MP) affecting the compound?

a)

the purity of the compound

b)

the product of the compound

c)

the weight of the compound

d)

the dimension of the compound

106.

When a compound has many impurities -

a)

the MP low

b)

the MP range is very broad

c)

the MP is high

d)

has a very small MP range

107.

What is polymorphism?

a)

the ability of a solid to exist in multiple forms or crystal structure

b)

the existing of multiple forms

c)

the disappearance of a product as it vaporizes

d)

ability of a product to vaporizes and reappear as a solid

108.

A crystal solid has:

a)

fixed internal structure

b)

is less soluble

c)

does not tend to change form

d)

none of these

109.

A molecule without a clearly define shape is -

a)

amorphous

b)

crystalline

c)

neither

d)

both

110.

An amorphous solid -

a)

no fixed internal structure

b)

higher solubility

c)

reverts to stable when stored

d)

lower solubility

111.

Which is the definition for enantiotrophs?

a)

one form stable over certain pressure or temperature; while the other is stable over a different pressure and temp range

b)

one form is stable over all temperatures below MP, while other forms are unstable

112.

Best definition for monotrophs.

a)

one form is stable over all temperatures below MP, while other forms are unstable

b)

one form stable over certain pressure or temperature; while the other is stable over a different pressure and temp range

113.

Which is reversible?

a)

enantiotropic

b)

monotropic

114.

Select the correct match

a)

enantiotropic/endothermic

b)

monotropic/endothermic

c)

enantiotropic/exothermic

d)

monotropic/exothermic

115.

Has a higher MP, lower heat of fusion

a)

enantiotropic

b)

monotropic

116.

These dosage form characteristic affect the bioavailability of a drug

a)

solid-state form

b)

disintegration/dissolution rate

c)

storage conditions

d)

particle size

117.

Type of dosage forms of parenteral injection RoA.

a)

aerosol

b)

sterile solution

c)

ointments

d)

suspensions

118.

What are the disadvantages of transdermal RoA?

a)

expensive

b)

low molecular weight with high partition coefficient are suitable for transdermal formulations

c)

controlled delivery of drugs

d)

having high molecular weight with low solubility to bypass skin layer

119.

Some factors effecting bioavailability.

a)

physiochemical properties of drug

b)

dosage form characteristics

c)

pharmaceutical excipients

d)

physiological factors and patient characteristics

120.

What are advantages of transdermal RoA?

a)

convenient

b)

can be removed

c)

escapes first pass effect

d)

controlled delivery of drugs