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PH 107 - Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices (Lec.) > Introduction to Pharmaceutical Dosage Forms, Drug Delivery System, and Medical Devices > Flashcards

Introduction to Pharmaceutical Dosage Forms, Drug Delivery System, and Medical Devices Flashcards

1
Q

Is an article/agent used in diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals

A

Drug

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2
Q

Used for the relief of pain

A

Analgesics

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3
Q

Used to relieve pain by interfering with nerve transmission

A

Anesthetics

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4
Q

Used to relieve gastric hyperacidity and the pain associated with duodenal or gastric ulcers

A

Antacids

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5
Q

Used to rid the body of worm infestation that have gained entry into the body through the gastrointestinal tract

A

Antihemintics

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6
Q

Used to relieve the chest pain associated with increased oxygen demand by the heart muscle due to physical exertion

A

Antianginals

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7
Q

Used to inhibit cholinergic nerves that are primary responsible for gastrointestinal hypersecretions and motility

A

Anticholinergics

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8
Q

Used to inhibit the clotting mechanism in patients who have a propensity for clotting

A

Anticoagulants

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9
Q

Used to depress brain nerve firing to control convulsive seizures in epilepsy

A

Anticonvulsants

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10
Q

Used to decrease gastrointestinal activity, adsorb toxins, and replace the bacterial flora

A

Antidiarrheals

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11
Q

Used to block the brain centers associated with vomiting

A

Antiemetics

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12
Q

Used to antagonize the pathological effects of histamine that is released as a consequence of various disease states

A

Antihistamines

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13
Q

Used to lower blood pressure

A

Antihypertensives

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14
Q

Are natural or synthetic agents that are able to inhibit the growth or destroy microorganisms

A

Anti-infectives/Sulfonamides

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15
Q

Are cellular toxins that function by destroying rapidly multiplying cells associated with cancer

A

Antineoplastics

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16
Q

Used to depress the CNS cough trigger and belong to the narcotic category of drugs

A

Antitussive

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17
Q

Used for treatment of viral infections such as herpes simplex, group A influence, and HIV infection

A

Antivirals

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18
Q

Used to relax bronchial smooth muscle, which dilates the airway that is usually constricted in pulmonary disease states

A

Bronchodilators

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19
Q

Are vasoconstrictors that cause the shrinking of mucus membranes, permitting improved air transit through the nasal and other air passages

A

Decongestants

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20
Q

Used to promote digestion of food in the gastrointestinal tract in individuals who have a defect in this activity

A

Digestants

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21
Q

Acts on the kidney to increase the output of urine, thus ultimately reducing edema fluid accumulation

A

Diuretics

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22
Q

Used to induce vomiting

A

Emetics

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23
Q

Used to produce and maintain sleep

A

Hypontics/Sedatives

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24
Q

Used to promote defecation in patients who are constipated or unable to empty the gastrointestinal tract of its waste materials

A

Laxatives/Cathartics

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25
Q

Used to produce a sense of detach calmness without depression of mental faculties or clouding of consciousness

A

Tranquilizers

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26
Q

Includes diagnostic aids, radioisotopes, and vitamins

A

Miscellaneous drugs

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27
Q

One who prepares and sells drugs or compounds for medicinal purposes

A

Apothecary

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28
Q

Word that connotes a charm/drug used for good or for evil

A

Pharmakon

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29
Q

Successful psychologic treatment rather than therapeutic effects

A

Placebo therapy

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30
Q

Dosage formulations used for clinical evaluation of a new drug

A

Clinical Drug Materials (CDM)

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31
Q

Promotes the right and safety of the subjects

A

Investigational New Drug (IND)

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32
Q

Gains permission to market the drug product

A

New Drug Application (NDA)

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33
Q

Application by the sponsor of approved NDA to make changes

A

Supplemental New Drug Application (SNDA)

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34
Q

Nonclinical laboratory studies and clinical investigations may be omitted, except those pertaining to the drug’s bioavailability

A

Abbreviated New Drug Application (ANDA)

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35
Q

Manufacture of biological such as blood products, vaccines, and toxins

A

Biologics License Application (BLA)

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36
Q

Brings together regulatory requirements

A

International Conference on Harmonization (ICH)

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37
Q

Active ingredient/component that produces pharmacologic activity

A

Drugs substance

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38
Q

Drug substance with unknown clinical, toxicologic, physical, and chemical properties

A

New Chemical Entity (NCE)

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39
Q

Finished dosage form (containing the drug subs + other excipients/inert substances)

A

Drug product

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40
Q

Used for single agents

A

Non-proprietary names

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41
Q

Associated with a single chemical entity or with a mixture of chemicals constituting a specific proprietary product

A

Proprietary/trademark names

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42
Q

Have served as a reservoir of potential drugs

A

Plant materials

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43
Q

Used as a tranquilizer and hypotensive agent

A

Rauwolfia serpentina

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44
Q

Used as an antidiabetic agent and for its antitumor activity

A

Vinca rosea

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45
Q

Are considered aromatic, bitter, anti-inflammatory, and bronchial smooth muscle relaxant

A

Vitex negundo

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46
Q

Used to treat skin infections, wounds, dysentery, and urinary tract infections

A

Mangostana garcinia

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47
Q

Includes serums, antitoxins, and vaccines

A

Biologicals

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48
Q

Year when Edward Genner worked on the smallpox vaccine

A

1796

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49
Q

From renal monkey

A

Poliomyelitis vaccine

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50
Q

From chick embryo

A

Mumps & influenza vaccine

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51
Q

From duck embryo

A

Rubella vaccine

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52
Q

Is a medical intervention based on the modification of the genetic material of living cells

A

Gene therapy

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53
Q

A drug that would produce the specifically desired effect

A

Goal drug

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54
Q

A prototype chemical compound that has fundamental desired biologic or pharmacologic activity

A

Lead compound

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55
Q

A term used to describe a compound that requires metabolic transformation after administration

A

Prodrug

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56
Q

A drug not recognized among experts as safe and effective

A

New drug

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57
Q

Treatment that are sought for to target small number of patients with rare conditions/diseases

A

Orphan drug

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58
Q

Rare disease/condition affecting fewer than 200,000 people

A

Orphan disease

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59
Q

5 examples of orphan disease

A

Chronic lymphocytes, Leukemia, Gaucher’s disease, Cystic fibrosis, AIDS

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60
Q

Used to obtain basic information on the drug’s effects that may be used to predict safe and effective use in humans

A

Pharmacologic profile

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61
Q

Use of computer graphics to present and manipulate the structure of the drug molecule to fit the stimulated molecular structure of the receptor site

A

Molecular graphics

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62
Q

Testing of large numbers of systematic organic compound or substance of natural origin for biologic activity

A

Random/non-targeted screening

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63
Q

Chemical alteration of an organic compound to enhance its usefulness as a drug

A

Molecular modification

64
Q

Drug design that interferes with the known or suspected biochemical pathway of mechanism of a disease process

A

Mechanism-based drug design

65
Q

Concerned with drugs, their sources, appearance, chemistry, action, and uses

A

Pharmacology

66
Q

Latin word which means drug

A

Pharmaco

67
Q

Latin word which means study of

A

Logos

68
Q

3 sub-areas of pharmacology

A

Pharmacodynamics, Pharmacokinetics, Clinical pharmacology

69
Q

Study of the biochemical and physiological effect of drugs and their mechanism of action

A

Pharmacodynamics

70
Q

Deals with the absorption, distribution, metabolism, and excretion (ADME) of the drug

A

Pharmacokinetics

71
Q

Applied pharmacologic principle to the study of the effects and action of drugs in human

A

Clinical pharmacology

72
Q

Transit through the liver and exposure to the hepatic enzyme system

A

1st pass effect

73
Q

Performed through the collection and analysis of urine, blood, feces samples

A

ADME studies

74
Q

Area of pharmacology that deals with the adverse or undesired effects of drugs

A

Toxicology

75
Q

Studies the toxic effect of a test compound when administered in single dose or multiple doses over a short period

A

Acute/short term toxicity studies

76
Q

Considered: the relationship to projected human clinical studies for safety

A

Subacute/subchronic studies

77
Q

Drugs intended to be given to humans for a week or more, animal studies of 90-180 days in length must demonstrate safety

A

Chronic toxicity studies

78
Q

Long term studies (18-24 months) with surviving animals killed and studied at defined weeks during the test period

A

Carcinogenicity studies

79
Q

Reveals any effect of an active ingredient on mammalian reproduction

A

Reproduction studies

80
Q

Determines whether test compound affects gene mutation or cause chromosome or DNA damage

A

Genetoxicity/mutagenecity studies

81
Q

Drug substance must possess some aqueous solubility for system absorption and therapeutic response

A

Drug solubility

82
Q

Drug molecules must first cross a biologic membrane of protein and lipid to produce a pharmacologic response

A

Partition coefficient

83
Q

Speed/rate at which a drug substance dissolved in a medium

A

Dissolution rate

84
Q

Affects the drug’s dissolution rate and rate & extent of absorption

A

Physical form & particle size

85
Q

Tests various temperatures, conditions of relative humidity, and environments of light, air, and packaging

A

Stability

86
Q

Includes proposed new drug, placebos, and drug products compared to new drug

A

Clinical supplies/clinical trial materials (CTM)

87
Q

Controlled studies where 1 of the parties are not knowledgeable of which product is being administered

A

Blinded studies

88
Q

Patient unaware of the agent administered, investigational drug, placebo, and comparator drug

A

Single blind studies

89
Q

Neither the patient nor the clinician is aware of the agent administered

A

Double blind studies

90
Q

All parties are aware of the products administered

A

Open label

91
Q

Design applicable to most clinical trials

A

Parallel designs

92
Q

Design used for comparing different treatments within individuals

A

Crossover designs

93
Q

Part of the IND application; submitted to ensure the appropriate design and conduct of investigation

A

Clinical protocol

94
Q

Stage where animal pharmacology and toxicology data are obtained

A

Preclinical stage

95
Q

Stage which is the initial introduction and includes 20-100 healthy volunteers

A

Phase I

96
Q

Stage where controlled clinical studies to several hundred patients with the disease/condition are treated

A

Phase II

97
Q

Phase where several hundred to several thousand patients with the disease/condition treated for which the drug was developed

A

Phase III

98
Q

Phase where completed studies are sufficient for the NDA

A

Phase 3a

99
Q

Phase where additional studies are used to gather supplemental information to support certain labelling requests

A

Phase 3b

100
Q

Phase which has continual clinical investigation and manufacturing scale-up activities

A

Phase IV

101
Q

Phase where product development continues after the FDA’s market approval of the product

A

Phase V

102
Q

Letter for approval of the application permitting marketing

A

Approval letter

103
Q

Letter for one or more deficiencies

A

Non-approvable letter

104
Q

Derived from biological assay methods; reflects drug’s potency

A

Units of activity

105
Q

Determines minimum concentration expected to produce the drug’s desired effects in a patient

A

Minimum effective concentration (MEC)

106
Q

Above the average blood serum concentration level producing toxic effects

A

Minimum toxic concentration (MTC)

107
Q

Produces the desired intensity of effect in 50% of the individuals tested

A

ED50/Median effective dose

108
Q

Produces a defined toxic effect in 50% of the individuals tested

A

TD50/Median toxic dose

109
Q

Ratio of drug’s median toxic dose and median effective dose

A

Therapeutic index

110
Q

Regularly schedule subsequent administration to keep the most desirable concentration of drug in the blood

A

Maintenance dosage

111
Q

Required to attain desired concentration of the drug in the blood of tissues

A

Initial priming/loading dose

112
Q

Protects the patient from contracting the illness

A

Prophylactic dose

113
Q

Administered to the patient after exposure or contraction of the illness

A

Therapeutic dose

114
Q

Effect of drug modified by prior/concurrent administration of another drug

A

Drug-drug interaction

115
Q

Direct application of the drug to desired site of action

A

Local effects

116
Q

Entrance of drug into circulatory system and transport to cellular site of its action

A

Systemic effects

117
Q

Route of administration - mouth

A

Oral

118
Q

Route of administration - git via mouth

A

Peroral

119
Q

Route of administration - under the tongue

A

Sublingual

120
Q

Route of administration - other than git (by injection)

A

Parenteral

121
Q

Route of administration - vein

A

Intravenous

122
Q

Route of administration - artery

A

Intraarterial

123
Q

Route of administration - heart

A

Intracardiac

124
Q

Route of administration - spine

A

Intraspinal/intrathecal

125
Q

Route of administration - bone

A

Intraosseous

126
Q

Route of administration - joint

A

Intraarticular

127
Q

Route of administration - joint-fluid area

A

Intrasynovial

128
Q

Route of administration - skin

A

Intracutaneous/intradermal

129
Q

Route of administration - beneath the skin

A

Subcutaneous

130
Q

Route of administration - muscle

A

Intramuscular

131
Q

Route of administration - skin surface

A

Epicutaneous, Transdermal

132
Q

Route of administration - conjunctiva

A

Conjunctival

133
Q

Route of administration - eye

A

Intraocular

134
Q

Route of administration - Nose

A

Intranasal

135
Q

Route of administration - ear

A

Aural

136
Q

Route of administration - lung

A

Intrarespiratory

137
Q

Route of administration - rectum

A

Rectal

138
Q

Route of administration - vagina

A

Vaginal

139
Q

Route most taken for systemic effects after absorption from various surfaces along git

A

Oral route

140
Q

Route for systemic action preferred for drugs that are destroyed/inactivated by the stomach and intestine environments

A

Rectal route

141
Q

Route where the drug is injected into the body using a fine needle at various sites and depths

A

Parenteral route

142
Q

Injected through layers of skin into the loose subcutaneous tissue

A

Subcutaneous/hypodermic injection

143
Q

Injected into the skeletal muscles

A

Intramuscular injection

144
Q

Injected directly into the veins of the forearm

A

Intravenous injection

145
Q

Injected/administered into the corium of the skin

A

Intradermal injection

146
Q

Route where the drug is applied topically to the skin

A

Epicutaneous route

147
Q

Slowly releases medication for percutaneous absorption

A

Transdermal delivery systems

148
Q

Transdermal delivery system - antianginal

A

Nitroglycerin

149
Q

Transdermal delivery system - smoking cessation

A

Nicotine

150
Q

Transdermal delivery system - estrogenic hormone

A

Estradiol

151
Q

Transdermal delivery system - antihypertensive

A

Clonidine

152
Q

Transdermal delivery system - antinausea

A

Scopolamine

153
Q

Route for eye, ear, and mucous membranes of the nose

A

Ocular, oral, and nasal routes

154
Q

Solutions, suspensions, and ointments for the eyes

A

Ophthalmic preparations

155
Q

Solutions/suspensions by drops as fine mist from a nasal spray container

A

Nasal preparations

156
Q

Viscid to soften earwax, relieve earache, or combat an ear infection

A

Otic/ear preparations

PH 107 - Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices (Lec.) (3 decks)

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