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Drug Delivery Systems > Quiz 1 Material > Flashcards

Quiz 1 Material Flashcards

1
Q

A branch of pharmaceutics that study the fate of drugs after administration to a living organism.

A

Pharmacokinetics

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2
Q

The study of drug concentration and it’s effect to the body.

A

Pharmacodynamics

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3
Q

Study of the impact of physicochemical properties of the drug and drug product on drug delivery and absorption under normal or pathological condition.

A

Bio-pharmaceutics

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4
Q

The influence of genetic variation on a drugs efficacy and toxicity

A

Pharmacogenomics

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5
Q

The technologies involving development of dosage forms

A

Pharmaceutical Technology

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6
Q

Pharmaceutics deals with all of the following except?
A. Preparation of dosage forms
B. Formulating a pure drug to dosage forms
C. Studying the physico-chemical properties of pure drug substance
D. Identifying the mechanism of action of a drug
E. Study the rate and extent of drug absorption

A

D. Identifying the mechanism of action of a drug

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7
Q

A substance used in the diagnoses, mitigation, treatment, cure, or prevention of disease in humans or other animals.

A

Drug

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8
Q

A drug that must change to an active compound after ingestion. Such conversion occurs through enzymatic and biochemical cleavage.

A

Pro-drug

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9
Q

In non-clinical development are humans involved or not?

A

No, non-human status

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10
Q

In clinical development are studies performed in humans?

A

Yes

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11
Q

A protein, enzyme, receptor, signaling, or other molecules that is/are responsible for development of a disease.

A

Target

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12
Q

A test protein, peptide, or compound that appears to act on targets.

A

Hit

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13
Q

Of the numerous hits or variants, the protein, peptide, or organic compound that show the highest degree of activity against the disease.

A

Lead

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14
Q

A protein, peptide, or organic compound that has most or all of the properties of a desired therapeutic agent.

A

Candidate

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15
Q

New Drug application, filed for initial testing of each new drug in humans.

A

Investigational New Drug Application

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16
Q

A marketed therapeutic agent

A

Product

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17
Q

First studies in humans, usually healthy humans, after obtaining IND. Single dose followed by short-term multiple dose studies - follow up for days to weeks.

A

Clinical Development Phase I

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18
Q

Determine effectiveness in conditions or diseases of interest.

A

Clinical Development Phase II

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19
Q

Confirm effectiveness in larger studies

A

Clinical Development Phase III

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20
Q

Post-approval studies

A

Clinical Development Phase IV

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21
Q

It takes about ___ years to develop a FDA approved brand name drug.

A

15

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22
Q

What kind of drug does not require preclinical development or the drug discovery process? What does this kind of drug require?

A

Generic Drugs

Bioequivalence study

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23
Q

Preclinical studies are performed in _________.

A

Animals

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24
Q

Clinical studies are performed in _______ at _______ different phases

A

Humans

Four

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25
Q

An active ingredient that produces pharmacological action or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease. Does this include the intermediates used in the synthesis of such ingredient?

A

Drug substance

No

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26
Q

A finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally but not necessarily, in association with one or more other ingredients.

A

Drug Product

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27
Q

An amount of drug that is enough to produce a therapeutic response without producing toxic effects

A

Dose

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28
Q

Which of the following statements are not correct?
A. Drug substance is the same as active ingredient
B. Tablet is a drug product
C. The terms ‘drug product’ and ‘drug substance’ can be used interchangeably
D. Prodrugs requires bio-transformation to become active
E. ‘Dose’ and ‘Dosage forms’ are used as synonyms

A

A. Drug substance is the same as active ingredient

D. Prodrugs requires bio-tansformation to become active

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29
Q

A dosage form offers which of the following advantages?
A. Provides a safe and vonvenient means of administering a drug
B. Enhances patient compliance
C. Protects the drug against chemical decompostiion
D. Conceals any unpleasant odor or taste
E. Ensures or controls the release of drug into the body
F. All of the above

A

F. All of the above

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30
Q

Identify the correct statement:
A. Some prescription drugs may not require FDA registration
B. Phase III trial is performed after FDA approval of a drug
C. Generic drug development involves all the steps that are required for a brand drug
D. Mutagenicity studies are performed in healthy humans.

A

B. Phase III trial is performed after FDA approval of a drug

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31
Q

What information does a dosage form include?

A
  • Name and quantities of ingredients
  • Mixing sequence
  • Processing steps
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32
Q

Additives in a pharmaceutical formulation.

A

Excipients

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33
Q

Physical-chemical properties of the drug substance

A

Drug Factors

34
Q

Factors that affect absorption of a drug substance from various routes of administration

A

Bio-pharmaceutic considerations

35
Q

Ingredient responsible for pharmacological effects

A

Active Ingredients

36
Q

Ingredients that do not have any pharmacological effects.

A

Inactive ingredients

37
Q

A trademark officially registered by a company.

A

Proprietary (Brand) Name

38
Q

The generally recognized or “common” name for a drug.

A

Non-proprietary (Generic) Name

39
Q

A copy of a brand drug product, comprising the same active ingredient(s), strength, and dosage form

A

Generic Product

40
Q

Identify true or false statements.
A. Proprietary name is the chemical name of a drug
B. The terms, ‘generic name’ and ‘generic product’ describe the same nomenclature
C. Generic name is the common name of a drug
D. Generic product is an imitation of a brand product

A

A. - False
B. - False
C. - True
D. - True

41
Q

Not considered dangerous for self-medication and you get these drugs without a prescription.

A

Over the Counter Drugs

42
Q

Refills have to be authorized and can only be dispensed with a prescription.

A

Legend Drugs (prescription)

43
Q

Drugs that have potential for abuse.

A

Controlled or Scheduled Drugs

44
Q

Drugs with no accepted medical use and high potential for abuse.

A

Schedule I

45
Q

Drugs with accepted medical uses but still have high potential for abuse. Causes severe psychological and physical dependence.

A

Schedule II

46
Q

These substances have an abuse potential less than those in schedule I and II. Can cause moderate or low physical dependence or high psychological dependence.

A

Schedule III

47
Q

Less potential for abuse than I, II, III. Causes limited psychological and physical dependence

A

Scedule IV

48
Q

Least potential for abuse

A

Schedule V

49
Q 
Which of the following drug class has the least potential for abuse?
A. Schedule I
B. Schedule II
C. Schedule III 
D. Schedule IV
C. Schedule V
A

C. Schedule V

50
Q

Organized sets of monographs or books that describe the standards for drugs.

A

Pharmacopeias

51
Q

True or False? Offical compendia considered the legal standard for drugs.

A

True

52
Q

True or False? USP is a reference book that establishes standards to be used by manufacturers to prepare drug products.

A

True

53
Q

True or False? USP is an independent, science-based public health organization.

A

True

54
Q

True or False? Monographs of drug substances are in the USP section and that of pharmaceutical ingredients are in the NF section.

A

True

55
Q

True or False? USP is the only pharmacopeia in the world.

A

False

56
Q

True or False? USP is used only in the United States.

A

False

57
Q

True or False? Monographs of USP mainly describes use of drugs.

A

False

58
Q

Drug administered by mouth, and tube feeding using nasogastric, gastrotomy, jejunostomy tubes.

A

Enteral Route

59
Q

Drugs administered by the mouth and the drug is absorbed by the GI tract.

A

Oral Route

60
Q

Where are oral drugs absorbed mainly?

A

Small Intestine

61
Q

What are the advantages to the oral route of administration?

A
  • Convenient and noninvasive
  • Good for ambulatory patients
  • Self-administration
62
Q

What are the disadvantages to the oral route of administration?

A
  • Not suitable for drugs that degrades in the GI tract
  • First-pass metabolism reduces drug absorption
  • Interaction with the GI tract and food
  • Unpleasant taste
63
Q

Solid dosage forms prepared by compression and contain medicinal substances

A

Tablets

64
Q

Solid dosage forms in which drug substances and appropriate excipients are enclosed in either hard or soft shell

A

Capsules

65
Q

Solid drug particles dispersed in a suitable vehicle

A

Suspensions

66
Q

When drugs are present in a homogenous solution

A

Solutions

67
Q

Looks like a capsule but is actually a tablet

A

Caplet

68
Q

Drug is placed under the tongue

A

Sublingual region

69
Q

The drug is held between the cheek and gingivae adjacent to the teeth

A

Buccal region

70
Q

What are the advantages to sublingual and buccal routes of administration?

A
  • Avoids first-pass metabolism and GI tract degredation

- Can be used in unconscious patients

71
Q

What are the disadvantages to sublingual and buccal routes of administration?

A
  • Not very pleasant

- Not good for drugs that are degraded in saliva

72
Q

What is it called when orally administered drugs enter the liver before entering the systemic circulation?

A

First-pass metabolism

73
Q

Routes of administration other than the oral route that are sterile, pyrogen free preparations called injections

A

Parenteral route

74
Q

What are the advantages of parenteral routes?

A
  • Used in emergency situations, uncooperative, or unconscious patients
  • Unreliable absorption from the GI tract
  • Inactivation or destruction from GI tract
75
Q

What are the disatvantages of parenteral routes?

A
  • Difficult to withdraw and prepare

- Must be sterile

76
Q

Injected into the corium, the more vascular layer of the skin, just beneath the epidermis.

A

Intradermal injections

77
Q

What is a common site of intradermal injections?

A

The anterior surface of the forearm

78
Q

Injected into the loose interstitial tissue, the layer of fat immediately under the skin.

A

Loose interstitial tissue

79
Q

What are some common sites of interstitial injections?

A
  • The outer surface of the upper arm
  • The anterior surface of the thigh
  • The lower portion of the abdomen
80
Q

Injections deep into the skeletal muscles at sites away from nerve and blood vessels

A

Intramuscular injections

81
Q

What are the common sites of intramuscular injections?

A
  • Buttocks
  • Upper arms
  • Lateral thighs
82
Q

Drugs administered via the large proximal veins in the large proximal veins in anterior surface of elbow, back of hand, and larger veins in the foot.

A

Intravenous injections

Drug Delivery Systems (1 decks)

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