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📋 PHAR 3: Pharmaceutical Dosage Forms > Chapter 2: New Drug Development and Approval Process > Flashcards

Chapter 2: New Drug Development and Approval Process Flashcards

1
Q

requires a new drug to be approved by the Food and Drug Administration before it may be legally introduced in the interstate commerce

A

the federal Food, Drug, and Cosmetic Act

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2
Q

initiated to define physical and chemical properties of the agent

A

preformulation studies

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3
Q

follow to develop the initial features of the proposed pharmaceutical product or dosage form

A

formulation studies

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4
Q

the federal Food, Drug, and Cosmetic Act is regulated by

A

Title 21 of the US Code of Federal Regulations

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5
Q

factors that triggered drug development

A

cumulative body of scientific and biomedical information generated worldwide,
combined efforts of those participating in drug discovery and development

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6
Q

pharmaceutical industry in the US grew rapidly during

A

World War II

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7
Q

discovered by Alexander Fleming in England

A

penicillin

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8
Q

penicillin became commercially available

A

1944

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9
Q

date of discovery of penicillin

A

1929

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10
Q

date of end of World War 2

A

1945

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11
Q

ways of producing new drugs

A

variety of natural sources,
synthesis in the laboratory,
creation through biotechnology

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12
Q

served as reservoir of potential new drugs

A

plant materials

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13
Q

major contributions to modern drug therapy may be attributed to

A

conversion of botanic folklore remedies into modern wonder drugs

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14
Q

a tranquilizer and hypotensive agent

A

reserpine

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15
Q

reserpine is isolated from

A

Rauwolfia serpentina

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16
Q

also known as periwinkle

A

Vinca rosea

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17
Q

original indication of vinca rosea

A

treatment of diabetis mellitus

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18
Q

after screening of pharmacological activities, V. rosea exhibited ____ capabilities

A

anti-tumor

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19
Q

materials of V. rosea for treating tumors

A

vinblastine,

vincristine

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20
Q

used in the treatment of ovarian cancer

A

paclitaxel (Taxol)

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21
Q

paclitaxel is isolated from

A

Pacific Yew Tree

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22
Q

also known as mexican yams

A

Dioscorea

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23
Q

rich in the chemical steroid structure from which cortisone and estrogen are derived

A

Dioscorea

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24
Q

hormonal substances such as thyroid extract, insulin, and pituitary hormone are derived from

A

endocrine glands of cattle, sheep, and swine

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25
Q

rich source of estrogen

A

urine of pregnant mares

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26
Q

pioneered work for smallpox vaccine in 1796

A

Edward Jenner

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27
Q

prepared in cultures of renal monkey tissue

A

poliomyelitis vaccine

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28
Q

prepared from fluids of chick embryo

A

mumps and influenza vaccine

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29
Q

prepared from duck embryo

A

rubella (German measles) vaccine

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30
Q

prepared from skin of bovine calves inoculated with vaccinia virus

A

smallpox vaccine

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31
Q

two basic technologies that drive the genetic field of drug development

A

recombinant DNA,

monoclonal antibody production

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32
Q

common characteristics of rDNA and mAb production

A

ability to manipulate and produce proteins,

ability to influence the cell’s ability to produce proteins

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33
Q

characteristics of rDNA technology

A

more fundamental of two techniques,
potential to produce any protein,
allows gene-splicing (transplant of genetic material from higher species into lowly bacterium)

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34
Q

more fundamental of two techniques

A

recombinant DNA technology

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35
Q

has the potential to produce any protein

A

recombinant DNA technology

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36
Q

allows gene-splicing

A

recombinant DNA technology

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37
Q

transplant of genetic material from higher species into lowly bacterium

A

gene-splicing

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38
Q

human insulin

A

recombinant DNA technology

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39
Q

human growth hormone

A

recombinant DNA technology

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40
Q

hepatitis B vaccine

A

recombinant DNA technology

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41
Q

epoetin alfa

A

recombinant DNA technology

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42
Q

interferon

A

recombinant DNA technology

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43
Q

characteristics of mAb production

A

conducted entirely within the cells of higher animals,
exploits ability of cells with the potential to produce a desired antibody,
stimulates an unending stream of pure antibody production

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44
Q

conducted entirely within the cells of higher animals

A

monoclonal antibody production

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45
Q

exploits ability of cells with the potential to produce a desired antibody

A

monoclonal antibody production

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46
Q

stimulates an unending stream of pure antibody production

A

monoclonal antibody production

47
Q

used in home pregnancy testing hormones

A

monoclonal antibody production

48
Q

lupus erythematosus

A

belilumab

49
Q

Hodgkin lymphoma

A

brentuximab

50
Q

colorectal cancer

A

cetuximab

51
Q

multiple sclerosis

A

natalizumab

52
Q

macular degeneration

A

ranibizumab

53
Q

rheumatoid arthritis

A

tocilizumab

54
Q

used to prevent, treat, cure, diagnose, or mitigate human disorders caused by genetic disorders

A

human gene therapy

55
Q

first human gene therapy

A

treatment of (ADA) adenosine deaminase deficiency

56
Q

produces specifically desired effect,
be administered by the most desired route (generally orally) at minimal dosage,
dosing frequency has optimal onset and duration of activity,
exhibit no side effects,
no residual effect

A

goal drug

57
Q

involves testing of large numbers of synthetic organic compounds or substance of natural origin for biologic activity

A

random or untargeted screening

58
Q

maybe used initially to detect an unknown activity of the test compound or substance or to identify the most promising compounds to be studied

A

random screens

59
Q

used to detect and evaluate biological activity

A

bioassays

60
Q

used to differentiate the effect and potency of the test agent

A

bioassays

61
Q

initial bioassays maybe performed in ___

A

in vitro (cell cultures)

62
Q

subsequent bioassays maybe performed in

A

in vivo (animals)

63
Q

chemical alteration of a known and previously characterized organic compound (lead compound) for the purpose of enhancing its usefulness as a drug

A

molecular modification

64
Q

means enhancing its specificity for a paticular body site, increasing its potency, improving its rate and extent of absorption, modifying to advantage its time course in the body, reducing its toxicity, or changing its physical or chemical properties to provide desired features

A

molecular modification

65
Q

molecular modification to design a drug that interferes specifically with the known or suspected biochemical pathway or mechanism of a disease process

A

mechanism-based drug design

66
Q

use of computer graphics to represent and manipulate the structure of drug molecule to fit the similated molecular structure of the receptor site

A

molecular graphics

67
Q

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

A

lead compound

68
Q

requires metabolic transformation after administration to produce the desired pharmacologically active compound

A

prodrug

69
Q

conversion of an inactive prodrug to an active compound occurs primarily through

A

enzymatic biochemical cleavage

70
Q

example of prodrug

A

enalapril maleate

71
Q

enalapril is bioactivayed by hydrolysis to ___

A

enalaprilat

72
Q

criteria of prodrug

A

solubility,
absorption,
biostability,
prolonged release

73
Q

active ingredient that has never before been marketed in the US in any form

A

new molecular entity

74
Q

A combination of two or more old drugs or a change in the usual proportions of drugs un an established combination product is considered the same if the change introduces a question of safety or efficacy.

A

false

75
Q

generally formidable that it soon is replaced in scientific communication by a shortened name

A

systematic name

76
Q

chemical’s nonproprietary (or generic name)

A

shortened name

77
Q

serves numerous and varied purposes, its principal function being to identify the substance to which it applies by means of designation

A

nonproprietary name

78
Q

nonproprietary name are issued only for ____ agents

A

single

79
Q

science concerned with drugs, their sources, appearance, chemistry, actions and uses

A

pharmacology

80
Q

subareas of pharmacology

A

pharmacodynamics,
pharmacokinetics,
clinical pharmacology

81
Q

study of biochemical and physiologic effects of drugs and their mechanisms of actions

A

pharmacodynamics

82
Q

deals with absorption, distribution, metabolish or biotransformation and excretion

A

pharmacokinetics

83
Q

also known as metabolism

A

biotransformation

84
Q

applies pharmacologic principles to the study of effects and actions of drug in humans

A

clinical pharmacology

85
Q

when the receptors are saturated, the effects of the specific interaction are ___

A

maximized

86
Q

today’s emphasis of drug development

A

identifying the cause and process of a disease and then designing molecules capable of interfering with that process

87
Q

the quantity of drug molecules available for interaction is related to

A

the capacity of the specific receptor site

88
Q

has worked toward harmonization or bringing together the regulatory requirements with the long-range goal of establishing a uniform set of standarfs for drug registration within geographic areas

A

International Conference on Harmonization

89
Q

required to report to FDA each adverse drug experience that is both serious or unexpected

A

drug’s sponsor

90
Q

day limit for reporting of adverse effects

A

15 day

91
Q

summary of all of the preclinical and clinical studies conducted over the period from drug discovery through product devolepment

A

labeling

92
Q

following summary information in the package insert

A 
description of the product,
clinical pharmacology,
indications and usage,
contraindications,
precautions,
adverse reactions,
drug abuse and dependence,
overdosage,
dosage and administration,
how supplied
93
Q

decides whether to allow sponsor to market the drug or not

A

FDA

94
Q

180 day period of receipt of an application

A

review clock

95
Q

types of letters FDA uses to respond to a drug’s sponsor

A

approval,

complete response

96
Q

drug has met agency standards and can be marketed in the US

A

approval

97
Q

review period for a drug is complete and the application is not yet ready for approval

A

complete response

98
Q

purpose of NDA

A

to gain permission to market drug product

99
Q

disease or condition that affects fewer than 200,000 people in the US

A

orphan disease

100
Q

amount of drug that will produce the desired effect in most adult patients

A

drug’s adult dose, or

starting dose

101
Q

determined during clinical investigation and is based largely on a drug’s inherent duration of action, its pharmacokinetic profile, and characteristics of the dosage form

A

dosage regimen

102
Q

amount administered to protect patient from contracting the illness

A

prophylactic dose

103
Q

administered to a patient after exposure or contraction to illness

A

therapeutic dose

104
Q

doses of vaccines expressed in

A

units of activity

105
Q

units of activity are derived from

A

bioassays

106
Q

minimum concentration that can be expected to produce the drug’s desired effects in a patient

A

minimum effective concentration (MEC)

107
Q

second level of serum concentration

A

minimum toxic concentration

108
Q

expected to produce dose-related toxic effects in the average individual

A

minimum toxic concentration

109
Q

amount that will produce desired intensity of the effect in 50% of the individuals tested

A

median effective dose

110
Q

relationship between desired and undesired effects of drug is expressed as

A

therapeutic index

111
Q

ratio between a drug’s median toxic dose and median effective dose

A

therapeutic index

112
Q

formula for therapeutic index

A

TD50/ED50

113
Q

negates desirable effects of drug

A

minimum toxic concentration

114
Q

ability to endure influence of a drug during continued use

A

drug tolerance

📋 PHAR 3: Pharmaceutical Dosage Forms (8 decks)

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