(Prelims) DDS_2 Lec Flashcards
1
Q
Organized sets of monographs or books containing such standards to be used by
those involved in the production of drugs and pharmaceutical products.
A
Pharmacopeia or Formularies
2
Q
American Pharmacopeia is so called as what
A
Lititz Pharmacopeia
2
Q
this is a 32page booklet containing information on 84 internal and 16 external drugs and
preparations.
A
American Pharmacopeia
2
Q
Pharmakon meaning
A
Drug
3
Q
Poiein meaning
A
make
3
Q
Great Britain Pharmacopeia
A
British Pharmacopeia
4
Q
father of the USP
A
Lyman Spalding
5
Q
Precursor to the USP
A
Massachusetts Pharmacopeia
6
Q
how many information of drugs in Massachusetts Pharmacopeia?
A
536 drugs and pharmaceutical preparations
7
Q
Arsphenamine discovered by who
A
Paul Ehrlich and Sahachiro Hata
7
Q
How many pages and drugs in USP?
A
272 pages, 217 drugs
7
Q
submitted a plan to the Medical Society of the County of New York for the
creation of a national pharmacopeia.
A
Lyman Spalding
8
Q
Arsphenamine started what era
A
era of chemotherapy
8
Q
specific agent against syphilis
A
Arsphenamine
9
Q
serve as therapeutic guide to the medical profession
A
United Stated Pharmacopeia
9
Q
Denied admission to the USP
A
National Formulary
10
Q
designating both the USP and NF as establishing legal standards for medicinal
and pharmaceutical substances.
A
President Theodore Roosevelt
10
Q
Signed into law the first federal Pure Food and Drug Act
A
President Theodore Roosevelt
11
Q
Section of Monographs for drug substances, dietary supplements, dosage forms, and
compounded preparations
A
USP Section
11
Q
purchased the NF, unifying the official compendia and providing the mechanism
for a single national compendium
A
United Stated Pharmacopeial Convention, Inc.
12
Q
such drugs also must comply with compendial standards for strength, quality, or
purity.
A
Adulterated
13
Q
Section of Monographs for pharmaceutical excipients
A
NF Section
14
Q
must comply with compendial standards for packaging and labeling
A
Misbranded
15
Q
Homeopathy was coined by who
A
Samuel Hahnemann
16
Homoios meaning?
Similar
17
Pathos meaning
Disease
18
Ensures the quality of Homepathic drugs
Homeopathic Pharmacopeia of the United States
19
Sci name of Poison Ivy
Toxicodendron radicans
19
causes a red, itchy rash
Poison Ivy
20
published by the World Health Organization (WHO) of the United Nations
International Pharmacopeia
21
Mexican Pharmacopeia
Farmacopea de los Estados Unidos Mexicanos
21
what pharmacopeia does Canada use
USP-NF
22
Brazilian Pharmacopeia
Farmacopeia Brasilieira
22
is an international standard that provides guidelines specifically on
quality management systems. Ability to consistently provide products and
services that meet customer and regulatory requirements and to demonstrate
continuous improvement
ISO 9001
23
is a set of internationally recognized standards for quality assurance
and management
ISO 9000
24
gives guidelines for enhancing an organization's ability to achieve
sustained success
ISO 9004
24
contains a model for quality assurance for the production, servicing and
installation of products.
ISO 9002
24
uses inspection and testing as a means to determine if final products or
services meet requirements.
ISO 9003
25
distributed by an otherwise reputable manufacturer as an elixir using diethylene
glycol as the solvent
Sulfanilamide
25
this amendment specifically prohibited false claims of therapeutic effects,
declaring such products misbranded.
Shirley Amendment
26
Established a legal distinction between prescription and over-the-counter (OTC) or
nonprescription drugs.
DURHAM-HUMPHREY AMENDMENT OF 1951
27
It is the responsibility of the ______ to either grant or deny permission to manufacture
and distribute a new product after review
FDA
27
Thalidomide was hoped to replace what
Barbiturates
28
recommended as a sedative and tranquilizer, was being sold OTC in Europe.
Thalidomide
29
Thalidomide given to women during pregnancy produced birth defects caused what
Phocomelia+
30
What is the use of thalidomide now
treatment of multiple myeloma
31
What is RA 9165
Comprehensive Dangerous Drugs Act
32
Determine if Sched 1-5?
no accepted medical use
potential for abuse ++++(high)
Sched 1
33
Determine if Sched 1-5?
accepted medical use
potential for abuse ++++ (high)
Sched 2
34
Determine if Sched 1-5?
accepted med use
potential for abuse +++ (moderate)
Sched 3
35
Determine if Sched 1-5?
accepted med use
potential for abuse ++ (low)
Sched 4
36
Determine if Sched 1-5?
accepted med use
potential for abuse + (low)
Sched 5
37
Determine if Sched 1-5?
Heroin
Sched 1
38
Determine if Sched 1-5?
Fentanyl
Sched 2
39
Determine if Sched 1-5?
Dihydrocodeine
Sched 5
39
Determine if Sched 1-5?
Tramadol
Sched 4
39
Determine if Sched 1-5?
Marijuana
Sched 1
40
Determine if Sched 1-5?
Ketamine
Sched 3
41
Determine if Sched 1-5?
Specified quantities of Codeine
Sched 3
41
Determine if Sched 1-5?
Cocaine
Sched 2
42
Determine if Sched 1-5?
Morphine
Sched 2
43
Used to call attention to one of the following situations
Black Box Warnings
Example: Morphine
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE THREATENING RESPIRATORY
DEPRESSION;NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
44
Drugs intended for the treatment of rare diseases and conditions
Orphan Drugs
45
How are Rare diseases defined
> affecting fewer than 200,000 people
> affecting more than 200,000 people but company is unlikely to recover its research and development costs
46
A treatment for Gaucher disease, which causes pain and damage to
tissue in the liver, spleen, lungs and bone marrow
Alglucerase
46
A therapy to treat cystic fibrosis, a genetic disorder that causes problems
with breathing and digestion
Ivacaftor
47
A drug product recall may be initiated by the FDA or by the manufacturer
Voluntary Recall
48
Classification indicating degree of hazard:
will cause serious adverse health consequences or death.
Class I
48
Classification indicating degree of hazard:
cause temporary or medically reversible adverse health consequences
or the probability of serious adverse health consequences
Class II
49
Classification indicating degree of hazard:
not likely to cause adverse health consequences
Class III
50
is that component of pharmacy practice which entails the
direct interaction of the pharmacist with the patient for the purpose of caring for
that patient'
s drug-related needs
Pharmaceutical care
51
To gain approval for marketing, a pharmaceutical company must demonstrate,
through supporting scientific evidence that the new drug or drug product is _________________ for its proposed use.
safe and effective
52
initiated to define the physical and chemical properties of the agent.
Preformulation studies
53
follow to develop the initial features of the proposed pharmaceutical product or
dosage form
Formulation studies
54
At the completion of the carefully designed preclinical and clinical studies, the drug’s
sponsor may file a what
New Drug Application
54
Only when the _______ demonstrate adequate safety and shows promise as a useful drug will the drug's sponsor file an ________________
Preclinical studies; Investigational New Drug Application
55
If there are no satisfactory approved drugs or treatment alternatives for a serious
medical condition, special protocols may be issued permitting the use of an investigational drug to
treat some patients prior to approval of the NDA
treatment IND
56
for distribution of biologics
Biologics Licensing Application (BLA)
57
gain approval to market a generic equivalent of a product that is already
approved and being marketed by the pioneer, or the original sponsor, of the drug
Abbreviated New Drug Application (ANDA)
58
the antibiotic that became commercially available in 1944, 15 years after its
discovery
Penicillin
59
Penicillin was found by who
Alexander Fleming
60
tranquilizer and hypotensive agent
Indian Snakeroot
61
treatment of diabetes mellitus
Periwinkle
62
treatment of ovarian cancer
Pacific Yew Tree
62
rich in the chemical steroid structure, from which cortisone and estrogens are semisynthetically produced
Mexican Yams
63
cultures of renal monkey tissue
Poliomyelitis vaccine
63
skin of bovine calves
Smallpox vaccine
63
fluids of chick embryo
Mumps and Influenza vaccines
63
a specific marker to pregnancy
Human Chorionic Gonadotropin (HCG) molecule
63
has the potential to produce almost any protein
Recombinant DNA
64
in duck embryo
Rubella (German measles) vaccine
65
the first recombinant biopharmaceutical approved in the United States in 1982
Human insulin
65
exploits the ability of cells with the potential to produce a desired antibody and
stimulates an unending stream of pure antibody production
mAb Production
66
modified outside the body
ex vivo
66
the first FDA-approved therapeutic mAb, a transplant rejection drug
Muromonab
67
The first human gene therapy used was to treat what
adenosine deaminase (ADA)
deficiency
67
used to prevent, treat, cure, diagnose, or mitigate human diseases caused by
genetic disorders
Human gene therapy
68
modified within the body
in vivo
69
examining 15,000 chemical compounds a week using 10 to 20 biologic assay
High-Throughput Screening
69
a condition that results in abnormal functioning of the immune system
adenosine deaminase (ADA)
deficiency
70
a chemical alteration of a known and previously characterized organic
compound, involving changes in functional groups, ring
structures, or configuration
Molecular Modification
70
involves the testing of large numbers of synthetic organic compounds or
substances of natural origin for biologic activity, detect an unknown activity of the test compound or substance
Random or Untargeted Screening
71
detect and evaluate biologic activity
Bioassays
71
identify the most promising compounds to be studied, determine a specific activity
Nonrandom or Targeted Screening
72
first commercial beta-blocker
Propranolol
73
first commercial histamine H2-receptor blocking agent
Cimetidine
74
design a drug that interferes specifically with the known or suspected
biochemical pathway or mechanism of a disease process
Mechanism-based drug design
75
inhibitor of histamine at the histamine H2-receptors, inhibits gastric acid secretion
Ranitidine
76
inhibits uptake of serotonin, useful in the treatment of depression
Sertraline
77
protect the drug during its transport in the body
Biostability
78
A compound that requires metabolic biotransformation after administration to
produce the desired pharmacologically active compound.
PRODRUGS
78
A prototype chemical compound that has a fundamental desired biologic or
pharmacologic activity
A LEAD COMPOUND
79
originally developed and approved to treat benign prostatic hyperplasia later on to treat male baldness
Finasteride
80
after oral administration, is bioactivated by hydrolysis to enalaprilat, an ACE
inhibitor used in the treatment of hypertension
Enalapril maleate
81
Prodrugs may be designed preferentially for what
Solubility, absorption, biostability, and prolonged release
82
depending on a prodrug’s rate of metabolic conversion to an active drug
Prolonged Release
83
The science concerned with drugs
PHARMACOLOGY
83
defined by the FDA as an active ingredient that has never before been marketed
New Molecular Entity (NME)
84
undergo preclinical testing for biologic activity to assess their potential as useful
therapeutic agents
Prospective drug substances
85
the study of the biochemical and physiologic effects of
drugs and their mechanisms of action
pharmacodynamics
effects of what the drug does to the body
86
effects of what the body does to the drug
pharmacokinetics
87
Main organ for drug metabolism?
Liver
88
Transit to the liver is termed as?
First Pass Effect
89
Route of Administration with 100% bioavailability?
Intravenous (IV)
90
undertaken to determine the presence of a test drug or its metabolites in the milk
of lactating animals; the ability of the drug to cross the placental barrier and enter the fetal blood
supply
Special studies
91
toxicity with short-term
acute effects
91
Deals with the adverse or undesired effects of drug.
TOXICOLOGY
92
toxicity with long-term use
chronic effects
92
determine the toxic effects of a test compound when administered in a single
dose and/or in multiple doses over a short period, usually a single day
Acute or Short-Term Toxicity Studie
92
minimum of 2 weeks of daily drug administration at three or more dosage levels
to two animal species
Subacute or Subchronic Toxicity Studies
93
drugs intended to human use for a week or more, animal studies of 90 to 180 days
must demonstrate safety
Chronic Toxicity Studies
94
undertaken when the compound has shown sufficient promise as a drug to enter
human clinical trials
Carcinogenicity Studies
95
determine whether the test compound can affect gene mutation or cause
chromosome or DNA damage
Genotoxicity or Mutagenicity Studies
95
An example of this is Salmonella typhimurium - used in assays to detect mutations
Ames Test
96
fertility and mating behavior; early embryonic, prenatal, and postnatal
development; multigenerational effects; and teratology
Reproduction Studies
97
aqueous solubility for systemic absorption and therapeutic response
Drug Solubility
97
must first cross a biologic membrane of protein and lipid
Partition Coefficient
98
speed at which a drug substance dissolves in a medium
Dissolution Rate
99
crystal or amorphous forms and/or the particle size
Physical Form
100
101
