Final 2

Question 1

Key step which enables a drug to be active in human body

Answer 1

Dissolution

Question 2

An API can be used in the manufacturing of a drug product until:
a. the expiration date
b. the date specified by the retest interval, when it can continue to be used
as long as retest results meet specifications
c. it is completely used up
d. the date specified by the retest interval, when it must be dispose

Answer 2

b. the date specified by the retest interval, when it can continue to be used
as long as retest results meet specifications

Question 3

The predominant route of administration to treat back of eye disorder is ____

Answer 3

Intravitreal

Question 4

The most stable crystal form of an API:

a. Has the highest solubility of all crystal forms of the API
b. Has the lowest solubility of all crystal forms of the API

Answer 4

a. Has the highest solubility of all crystal forms of the API

Question 5

When a drug is delivered using a DUROS implant, constant drug release can be achieved for a year. The mechanism of release used in this system is:

Answer 5

Osmotic Pump

Question 6

The percentage of drugs dispensed generically in the US is:

Answer 6

90%

Question 7

Often, the most critical excipient for a pediatric formulation is:

Answer 7

Flavoring

Question 7

Often, the most critical excipient for a pediatric formulation is:

Answer 7

Flavoring

Question 8

An ANDA for a generic drug must contain:

Answer 8

Bioequivalence data

Question 9

Otic medicine is generally applied externally. Are otic drug products required to be sterile?

Answer 9

Yes

Question 10

The most common source of microbial contamination in the clean room environment is:

Answer 10

Personnel environmental contact

Question 11

Which of the following factors are important to consider with developing an ophthalmic formulation?

a. sterility
b. tonicity
c. pH
d. All of the above

Answer 11

d. All of the above

Question 12

True/False: The approval process in the US is the same for generic biotechnology-derived drugs as for traditional small drugs

Answer 12

False

Question 13

The salt form of a drug substance:

a. Always the preferred form
b. Often used to increase aqueous solubility of drug substance

Answer 13

b. Often used to increase aqueous solubility of drug substance

Question 14

Drugs administered nasally can be used for:

a. CNS delivery
b. Systemic
c. Local
d. All of the above

Answer 14

d. All of the above

Question 15

True/False: Appearance of the drug product should be included on the specification at release AND on stability

Answer 15

True

Question 16

True/False: All prescription drugs are FDA regulated

Answer 16

True

Question 17

The current thinking is that children must be protected:

Answer 17

Through clinical research

Question 18

Which of the following is NOT a method used for terminal sterilization of sterile solutions?

a. In-process filtration with aseptic processing
b. moist heat
c. UV light
d. dry heat

Answer 18

a. In-process filtration with aseptic processing

I think this is incorrect; verify

Question 19

The primary type of excipient used in lyophilization is:

a. a lubricant
b. a colorant
c. a bulking agent
d. a preservative

Answer 19

c. a bulking agent

Question 20

When engineering your powder formulation for pulmonary delivery, your ideal formulation would contain

a. uniform particle size
b. wide range of particle sizes
c. particles can’t be used, only liquid

Answer 20

a. uniform particle size

Question 21

Noninvasive routes of administration ALWAYS:

a. have improved patient compliance
b. require the drug to pass across a mucosal or cellular barrier
c. have a slower onset of action
d. all

Answer 21

b. require the drug to pass across a mucosal or cellular barrier

Question 22

Lipophilic drugs more easily permeate cells via:

a. transcellular transport
b. paracellular
c. either type
d. neither type

Answer 22

a. transcellular transport

Question 23

Amorphous solids are sometimes produced for use in the final dosage form because:

a. they have higher solubility than crystalline
b. they are more chemically stable than crystalline
c. they can convert to the crystalline form
d. they are more physically stable than the crystalline form

Answer 23

a. they have higher solubility than crystalline

Question 24

Excipients are also referred to as:

Answer 24

Inactive ingredients

Question 25

PLGA can NOT be used to make:

a. gels
b. implantable rods
c. microspheres
d. All of it can be used

Answer 25

d. All of it can be used

Question 26

A drug that exhibits polymorphism:

a. can exist in more than one crystal form
b. requires sterilization
c. is amorphous
d. can not be made into suitable drug product

Answer 26

a. can exist in more than one crystal form

Question 27

In a drug product, “API” is a synonym for:

a. the excipient
b. the crystal form
c. the dosage form
d. the drug substance

Answer 27

d. the drug substance

Question 28

TRUE/FALSE: PLGA has ideal release characteristics

Answer 28

FALSE

It not great for release but it’s good enough

Question 29

APIs can NOT be:

Answer 29

Complex mixtures