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
2
Q
initiated to define physical and chemical properties of the agent
A
preformulation studies
3
Q
follow to develop the initial features of the proposed pharmaceutical product or dosage form
A
formulation studies
4
Q
the federal Food, Drug, and Cosmetic Act is regulated by
A
Title 21 of the US Code of Federal Regulations
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
6
Q
pharmaceutical industry in the US grew rapidly during
A
World War II
7
Q
discovered by Alexander Fleming in England
A
penicillin
8
Q
penicillin became commercially available
A
1944
9
Q
date of discovery of penicillin
A
1929
10
Q
date of end of World War 2
A
1945
11
Q
ways of producing new drugs
A
variety of natural sources,
synthesis in the laboratory,
creation through biotechnology
12
Q
served as reservoir of potential new drugs
A
plant materials
13
Q
major contributions to modern drug therapy may be attributed to
A
conversion of botanic folklore remedies into modern wonder drugs
14
Q
a tranquilizer and hypotensive agent
A
reserpine
15
Q
reserpine is isolated from
A
Rauwolfia serpentina
16
Q
also known as periwinkle
A
Vinca rosea
17
Q
original indication of vinca rosea
A
treatment of diabetis mellitus
18
Q
after screening of pharmacological activities, V. rosea exhibited ____ capabilities
A
anti-tumor
19
Q
materials of V. rosea for treating tumors
A
vinblastine,
vincristine
20
Q
used in the treatment of ovarian cancer
A
paclitaxel (Taxol)
21
Q
paclitaxel is isolated from
A
Pacific Yew Tree
22
Q
also known as mexican yams
A
Dioscorea
23
Q
rich in the chemical steroid structure from which cortisone and estrogen are derived
A
Dioscorea
24
Q
hormonal substances such as thyroid extract, insulin, and pituitary hormone are derived from
A
endocrine glands of cattle, sheep, and swine
25
rich source of estrogen
urine of pregnant mares
26
pioneered work for smallpox vaccine in 1796
Edward Jenner
27
prepared in cultures of renal monkey tissue
poliomyelitis vaccine
28
prepared from fluids of chick embryo
mumps and influenza vaccine
29
prepared from duck embryo
rubella (German measles) vaccine
30
prepared from skin of bovine calves inoculated with vaccinia virus
smallpox vaccine
31
two basic technologies that drive the genetic field of drug development
recombinant DNA,
| monoclonal antibody production
32
common characteristics of rDNA and mAb production
ability to manipulate and produce proteins,
| ability to influence the cell's ability to produce proteins
33
characteristics of rDNA technology
more fundamental of two techniques,
potential to produce any protein,
allows gene-splicing (transplant of genetic material from higher species into lowly bacterium)
34
more fundamental of two techniques
recombinant DNA technology
35
has the potential to produce any protein
recombinant DNA technology
36
allows gene-splicing
recombinant DNA technology
37
transplant of genetic material from higher species into lowly bacterium
gene-splicing
38
human insulin
recombinant DNA technology
39
human growth hormone
recombinant DNA technology
40
hepatitis B vaccine
recombinant DNA technology
41
epoetin alfa
recombinant DNA technology
42
interferon
recombinant DNA technology
43
characteristics of mAb production
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
44
conducted entirely within the cells of higher animals
monoclonal antibody production
45
exploits ability of cells with the potential to produce a desired antibody
monoclonal antibody production
46
stimulates an unending stream of pure antibody production
monoclonal antibody production
47
used in home pregnancy testing hormones
monoclonal antibody production
48
lupus erythematosus
belilumab
49
Hodgkin lymphoma
brentuximab
50
colorectal cancer
cetuximab
51
multiple sclerosis
natalizumab
52
macular degeneration
ranibizumab
53
rheumatoid arthritis
tocilizumab
54
used to prevent, treat, cure, diagnose, or mitigate human disorders caused by genetic disorders
human gene therapy
55
first human gene therapy
treatment of (ADA) adenosine deaminase deficiency
56
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
goal drug
57
involves testing of large numbers of synthetic organic compounds or substance of natural origin for biologic activity
random or untargeted screening
58
maybe used initially to detect an unknown activity of the test compound or substance or to identify the most promising compounds to be studied
random screens
59
used to detect and evaluate biological activity
bioassays
60
used to differentiate the effect and potency of the test agent
bioassays
61
initial bioassays maybe performed in ___
in vitro (cell cultures)
62
subsequent bioassays maybe performed in
in vivo (animals)
63
chemical alteration of a known and previously characterized organic compound (lead compound) for the purpose of enhancing its usefulness as a drug
molecular modification
64
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
molecular modification
65
molecular modification to design a drug that interferes specifically with the known or suspected biochemical pathway or mechanism of a disease process
mechanism-based drug design
66
use of computer graphics to represent and manipulate the structure of drug molecule to fit the similated molecular structure of the receptor site
molecular graphics
67
prototype chemical compound that has a fundamental desired biologic or pharmacologic activity
lead compound
68
requires metabolic transformation after administration to produce the desired pharmacologically active compound
prodrug
69
conversion of an inactive prodrug to an active compound occurs primarily through
enzymatic biochemical cleavage
70
example of prodrug
enalapril maleate
71
enalapril is bioactivayed by hydrolysis to ___
enalaprilat
72
criteria of prodrug
solubility,
absorption,
biostability,
prolonged release
73
active ingredient that has never before been marketed in the US in any form
new molecular entity
74
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.
false
75
generally formidable that it soon is replaced in scientific communication by a shortened name
systematic name
76
chemical's nonproprietary (or generic name)
shortened name
77
serves numerous and varied purposes, its principal function being to identify the substance to which it applies by means of designation
nonproprietary name
78
nonproprietary name are issued only for ____ agents
single
79
science concerned with drugs, their sources, appearance, chemistry, actions and uses
pharmacology
80
subareas of pharmacology
pharmacodynamics,
pharmacokinetics,
clinical pharmacology
81
study of biochemical and physiologic effects of drugs and their mechanisms of actions
pharmacodynamics
82
deals with absorption, distribution, metabolish or biotransformation and excretion
pharmacokinetics
83
also known as metabolism
biotransformation
84
applies pharmacologic principles to the study of effects and actions of drug in humans
clinical pharmacology
85
when the receptors are saturated, the effects of the specific interaction are ___
maximized
86
today's emphasis of drug development
identifying the cause and process of a disease and then designing molecules capable of interfering with that process
87
the quantity of drug molecules available for interaction is related to
the capacity of the specific receptor site
88
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
International Conference on Harmonization
89
required to report to FDA each adverse drug experience that is both serious or unexpected
drug's sponsor
90
day limit for reporting of adverse effects
15 day
91
summary of all of the preclinical and clinical studies conducted over the period from drug discovery through product devolepment
labeling
92
following summary information in the package insert
```
description of the product,
clinical pharmacology,
indications and usage,
contraindications,
precautions,
adverse reactions,
drug abuse and dependence,
overdosage,
dosage and administration,
how supplied
```
93
decides whether to allow sponsor to market the drug or not
FDA
94
180 day period of receipt of an application
review clock
95
types of letters FDA uses to respond to a drug's sponsor
approval,
| complete response
96
drug has met agency standards and can be marketed in the US
approval
97
review period for a drug is complete and the application is not yet ready for approval
complete response
98
purpose of NDA
to gain permission to market drug product
99
disease or condition that affects fewer than 200,000 people in the US
orphan disease
100
amount of drug that will produce the desired effect in most adult patients
drug's adult dose, or
| starting dose
101
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
dosage regimen
102
amount administered to protect patient from contracting the illness
prophylactic dose
103
administered to a patient after exposure or contraction to illness
therapeutic dose
104
doses of vaccines expressed in
units of activity
105
units of activity are derived from
bioassays
106
minimum concentration that can be expected to produce the drug's desired effects in a patient
minimum effective concentration (MEC)
107
second level of serum concentration
minimum toxic concentration
108
expected to produce dose-related toxic effects in the average individual
minimum toxic concentration
109
amount that will produce desired intensity of the effect in 50% of the individuals tested
median effective dose
110
relationship between desired and undesired effects of drug is expressed as
therapeutic index
111
ratio between a drug's median toxic dose and median effective dose
therapeutic index
112
formula for therapeutic index
TD50/ED50
113
negates desirable effects of drug
minimum toxic concentration
114
ability to endure influence of a drug during continued use
drug tolerance
