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2nd Year - 1st Sem > (Prelims) DDS_2 Lec > Flashcards

(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

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2
Q

American Pharmacopeia is so called as what

A

Lititz Pharmacopeia

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2
Q

this is a 32page booklet containing information on 84 internal and 16 external drugs and
preparations.

A

American Pharmacopeia

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2
Q

Pharmakon meaning

A

Drug

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3
Q

Poiein meaning

A

make

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3
Q

Great Britain Pharmacopeia

A

British Pharmacopeia

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4
Q

father of the USP

A

Lyman Spalding

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5
Q

Precursor to the USP

A

Massachusetts Pharmacopeia

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6
Q

how many information of drugs in Massachusetts Pharmacopeia?

A

536 drugs and pharmaceutical preparations

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7
Q

Arsphenamine discovered by who

A

Paul Ehrlich and Sahachiro Hata

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7
Q

How many pages and drugs in USP?

A

272 pages, 217 drugs

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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

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8
Q

Arsphenamine started what era

A

era of chemotherapy

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8
Q

specific agent against syphilis

A

Arsphenamine

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9
Q

serve as therapeutic guide to the medical profession

A

United Stated Pharmacopeia

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9
Q

Denied admission to the USP

A

National Formulary

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10
Q

designating both the USP and NF as establishing legal standards for medicinal
and pharmaceutical substances.

A

President Theodore Roosevelt

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10
Q

Signed into law the first federal Pure Food and Drug Act

A

President Theodore Roosevelt

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11
Q

Section of Monographs for drug substances, dietary supplements, dosage forms, and
compounded preparations

A

USP Section

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11
Q

purchased the NF, unifying the official compendia and providing the mechanism
for a single national compendium

A

United Stated Pharmacopeial Convention, Inc.

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12
Q

such drugs also must comply with compendial standards for strength, quality, or
purity.

A

Adulterated

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13
Q

Section of Monographs for pharmaceutical excipients

A

NF Section

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14
Q

must comply with compendial standards for packaging and labeling

A

Misbranded

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15
Q

Homeopathy was coined by who

A

Samuel Hahnemann

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16
Q

Homoios meaning?

A

Similar

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17
Q

Pathos meaning

A

Disease

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18
Q

Ensures the quality of Homepathic drugs

A

Homeopathic Pharmacopeia of the United States

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19
Q

Sci name of Poison Ivy

A

Toxicodendron radicans

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19
Q

causes a red, itchy rash

A

Poison Ivy

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20
Q

published by the World Health Organization (WHO) of the United Nations

A

International Pharmacopeia

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21
Q

Mexican Pharmacopeia

A

Farmacopea de los Estados Unidos Mexicanos

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21
Q

what pharmacopeia does Canada use

A

USP-NF

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22
Q

Brazilian Pharmacopeia

A

Farmacopeia Brasilieira

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22
Q

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

A

ISO 9001

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23
Q

is a set of internationally recognized standards for quality assurance
and management

A

ISO 9000

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24
Q

gives guidelines for enhancing an organization’s ability to achieve
sustained success

A

ISO 9004

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24
Q

contains a model for quality assurance for the production, servicing and
installation of products.

A

ISO 9002

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24
Q

uses inspection and testing as a means to determine if final products or
services meet requirements.

A

ISO 9003

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25
Q

distributed by an otherwise reputable manufacturer as an elixir using diethylene
glycol as the solvent

A

Sulfanilamide

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25
Q

this amendment specifically prohibited false claims of therapeutic effects,
declaring such products misbranded.

A

Shirley Amendment

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26
Q

Established a legal distinction between prescription and over-the-counter (OTC) or
nonprescription drugs.

A

DURHAM-HUMPHREY AMENDMENT OF 1951

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27
Q

It is the responsibility of the ______ to either grant or deny permission to manufacture
and distribute a new product after review

A

FDA

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27
Q

Thalidomide was hoped to replace what

A

Barbiturates

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28
Q

recommended as a sedative and tranquilizer, was being sold OTC in Europe.

A

Thalidomide

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29
Q

Thalidomide given to women during pregnancy produced birth defects caused what

A

Phocomelia+

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30
Q

What is the use of thalidomide now

A

treatment of multiple myeloma

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31
Q

What is RA 9165

A

Comprehensive Dangerous Drugs Act

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32
Q

Determine if Sched 1-5?

no accepted medical use
potential for abuse ++++(high)

A

Sched 1

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33
Q

Determine if Sched 1-5?

accepted medical use
potential for abuse ++++ (high)

A

Sched 2

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34
Q

Determine if Sched 1-5?

accepted med use
potential for abuse +++ (moderate)

A

Sched 3

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35
Q

Determine if Sched 1-5?

accepted med use
potential for abuse ++ (low)

A

Sched 4

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36
Q

Determine if Sched 1-5?

accepted med use
potential for abuse + (low)

A

Sched 5

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37
Q

Determine if Sched 1-5?

Heroin

A

Sched 1

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38
Q

Determine if Sched 1-5?

Fentanyl

A

Sched 2

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39
Q

Determine if Sched 1-5?

Dihydrocodeine

A

Sched 5

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39
Q

Determine if Sched 1-5?

Tramadol

A

Sched 4

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39
Q

Determine if Sched 1-5?

Marijuana

A

Sched 1

40
Q

Determine if Sched 1-5?

Ketamine

A

Sched 3

41
Q

Determine if Sched 1-5?

Specified quantities of Codeine

A

Sched 3

41
Q

Determine if Sched 1-5?

Cocaine

A

Sched 2

42
Q

Determine if Sched 1-5?

Morphine

A

Sched 2

43
Q

Used to call attention to one of the following situations

A

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
Q

Drugs intended for the treatment of rare diseases and conditions

A

Orphan Drugs

45
Q

How are Rare diseases defined

A

> affecting fewer than 200,000 people
affecting more than 200,000 people but company is unlikely to recover its research and development costs

46
Q

A treatment for Gaucher disease, which causes pain and damage to
tissue in the liver, spleen, lungs and bone marrow

A

Alglucerase

46
Q

A therapy to treat cystic fibrosis, a genetic disorder that causes problems
with breathing and digestion

A

Ivacaftor

47
Q

A drug product recall may be initiated by the FDA or by the manufacturer

A

Voluntary Recall

48
Q

Classification indicating degree of hazard:

will cause serious adverse health consequences or death.

A

Class I

48
Q

Classification indicating degree of hazard:

cause temporary or medically reversible adverse health consequences
or the probability of serious adverse health consequences

A

Class II

49
Q

Classification indicating degree of hazard:

not likely to cause adverse health consequences

A

Class III

50
Q

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

A

Pharmaceutical care

51
Q

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.

A

safe and effective

52
Q

initiated to define the physical and chemical properties of the agent.

A

Preformulation studies

53
Q

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

A

Formulation studies

54
Q

At the completion of the carefully designed preclinical and clinical studies, the drug’s
sponsor may file a what

A

New Drug Application

54
Q

Only when the _______ demonstrate adequate safety and shows promise as a useful drug will the drug’s sponsor file an ________________

A

Preclinical studies; Investigational New Drug Application

55
Q

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

A

treatment IND

56
Q

for distribution of biologics

A

Biologics Licensing Application (BLA)

57
Q

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

A

Abbreviated New Drug Application (ANDA)

58
Q

the antibiotic that became commercially available in 1944, 15 years after its
discovery

A

Penicillin

59
Q

Penicillin was found by who

A

Alexander Fleming

60
Q

tranquilizer and hypotensive agent

A

Indian Snakeroot

61
Q

treatment of diabetes mellitus

A

Periwinkle

62
Q

treatment of ovarian cancer

A

Pacific Yew Tree

62
Q

rich in the chemical steroid structure, from which cortisone and estrogens are semisynthetically produced

A

Mexican Yams

63
Q

cultures of renal monkey tissue

A

Poliomyelitis vaccine

63
Q

skin of bovine calves

A

Smallpox vaccine

63
Q

fluids of chick embryo

A

Mumps and Influenza vaccines

63
Q

a specific marker to pregnancy

A

Human Chorionic Gonadotropin (HCG) molecule

63
Q

has the potential to produce almost any protein

A

Recombinant DNA

64
Q

in duck embryo

A

Rubella (German measles) vaccine

65
Q

the first recombinant biopharmaceutical approved in the United States in 1982

A

Human insulin

65
Q

exploits the ability of cells with the potential to produce a desired antibody and
stimulates an unending stream of pure antibody production

A

mAb Production

66
Q

modified outside the body

A

ex vivo

66
Q

the first FDA-approved therapeutic mAb, a transplant rejection drug

A

Muromonab

67
Q

The first human gene therapy used was to treat what

A

adenosine deaminase (ADA)
deficiency

67
Q

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

A

Human gene therapy

68
Q

modified within the body

A

in vivo

69
Q

examining 15,000 chemical compounds a week using 10 to 20 biologic assay

A

High-Throughput Screening

69
Q

a condition that results in abnormal functioning of the immune system

A

adenosine deaminase (ADA)
deficiency

70
Q

a chemical alteration of a known and previously characterized organic
compound, involving changes in functional groups, ring
structures, or configuration

A

Molecular Modification

70
Q

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

A

Random or Untargeted Screening

71
Q

detect and evaluate biologic activity

A

Bioassays

71
Q

identify the most promising compounds to be studied, determine a specific activity

A

Nonrandom or Targeted Screening

72
Q

first commercial beta-blocker

A

Propranolol

73
Q

first commercial histamine H2-receptor blocking agent

A

Cimetidine

74
Q

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

A

Mechanism-based drug design

75
Q

inhibitor of histamine at the histamine H2-receptors, inhibits gastric acid secretion

A

Ranitidine

76
Q

inhibits uptake of serotonin, useful in the treatment of depression

A

Sertraline

77
Q

protect the drug during its transport in the body

A

Biostability

78
Q

A compound that requires metabolic biotransformation after administration to
produce the desired pharmacologically active compound.

A

PRODRUGS

78
Q

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

A

A LEAD COMPOUND

79
Q

originally developed and approved to treat benign prostatic hyperplasia later on to treat male baldness

A

Finasteride

80
Q

after oral administration, is bioactivated by hydrolysis to enalaprilat, an ACE
inhibitor used in the treatment of hypertension

A

Enalapril maleate

81
Q

Prodrugs may be designed preferentially for what

A

Solubility, absorption, biostability, and prolonged release

82
Q

depending on a prodrug’s rate of metabolic conversion to an active drug

A

Prolonged Release

83
Q

The science concerned with drugs

A

PHARMACOLOGY

83
Q

defined by the FDA as an active ingredient that has never before been marketed

A

New Molecular Entity (NME)

84
Q

undergo preclinical testing for biologic activity to assess their potential as useful
therapeutic agents

A

Prospective drug substances

85
Q

the study of the biochemical and physiologic effects of
drugs and their mechanisms of action

A

pharmacodynamics

effects of what the drug does to the body

86
Q

effects of what the body does to the drug

A

pharmacokinetics

87
Q

Main organ for drug metabolism?

A

Liver

88
Q

Transit to the liver is termed as?

A

First Pass Effect

89
Q

Route of Administration with 100% bioavailability?

A

Intravenous (IV)

90
Q

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

A

Special studies

91
Q

toxicity with short-term

A

acute effects

91
Q

Deals with the adverse or undesired effects of drug.

A

TOXICOLOGY

92
Q

toxicity with long-term use

A

chronic effects

92
Q

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

A

Acute or Short-Term Toxicity Studie

92
Q

minimum of 2 weeks of daily drug administration at three or more dosage levels
to two animal species

A

Subacute or Subchronic Toxicity Studies

93
Q

drugs intended to human use for a week or more, animal studies of 90 to 180 days
must demonstrate safety

A

Chronic Toxicity Studies

94
Q

undertaken when the compound has shown sufficient promise as a drug to enter
human clinical trials

A

Carcinogenicity Studies

95
Q

determine whether the test compound can affect gene mutation or cause
chromosome or DNA damage

A

Genotoxicity or Mutagenicity Studies

95
Q

An example of this is Salmonella typhimurium - used in assays to detect mutations

A

Ames Test

96
Q

fertility and mating behavior; early embryonic, prenatal, and postnatal
development; multigenerational effects; and teratology

A

Reproduction Studies

97
Q

aqueous solubility for systemic absorption and therapeutic response

A

Drug Solubility

97
Q

must first cross a biologic membrane of protein and lipid

A

Partition Coefficient

98
Q

speed at which a drug substance dissolves in a medium

A

Dissolution Rate

99
Q

crystal or amorphous forms and/or the particle size

A

Physical Form

100
Q
A
101
Q
A

2nd Year - 1st Sem (20 decks)

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