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DDS LEC > 1-27 > Flashcards

1-27 Flashcards

1
Q

Dosage formulations used for clinical evaluation of a newdrug

A

Clinical Drug Materials

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2
Q

CTM

A

Clinical Drug Materials

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3
Q

Protects the right & safety of the subjects

A

Investigation New Drug (IND)

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4
Q

IND

A

Investigation New Drug (IND)

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5
Q

ensures investigational plan is sound & designed to achieve the stated objectives

A

Investigation New Drug (IND)

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6
Q

Gains permission to market the drug product

A

New Drug Application (NDA)

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7
Q

NDA

A

New Drug Application

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8
Q

Application by the sponsor of approved NDA to make changes

A

Supplemental New Drug Application (SNDA)

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9
Q

SNDA

A

Supplemental New Drug Application (SNDA)

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10
Q

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

A

Abbreviated New Drug Application (ANDA)

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11
Q

ANDA

A

Abbreviated New Drug Application (ANDA)

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12
Q

Manufacture of biologicals (blood products, vaccines, & toxins)

A

Biologics License Application (BLA)

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13
Q

BLA

A

Biologics License Application

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14
Q

Brings together regulatory requirements

A

International Conference on Harmonization (ICH)

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15
Q

establishes (long range goal) a uniform set of standards
for drug registration within geographic areas

A

International Conference on Harmonization (ICH)

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16
Q

ICH

A

International Conference on Harmonization (ICH)

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17
Q

active ingredient/component that produces pharmacologic activity

A

Drugs Substance

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18
Q

Enumerate how is drugs substance produced by?

A
  • chem. synthesis
  • enzymatic reaction
  • recovery from a natural product
  • recombinant DNA tech.
  • fermentation
  • combination of these processes
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19
Q

Purification needed before use in a drug product

A

Drug Susbtance

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20
Q

drug substance with unknown clinical, toxicologic, physical & chem. properties

A

NEW CHEMICAL ENTITY (NCE)

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21
Q

NCE

A

NEW CHEMICAL ENTITY (NCE)

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22
Q

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

A

Drug Product

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23
Q

refer to pharmaceutical products that pertain to chemical compounds or biological substances, other than food, intended for use in the treatment,
prevention, or diagnosis of disease in humans or animals,

A

Drugs

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24
Q

Any article recognized in the official United States
Pharmacopeia/National Formulary, Homeopathic Pharmacopeia of
the United States of America, Philippine Pharmacopeia, Philippine
National Drug Formulary, British Pharmacopoeia, European
Pharmacopoeia, Japanese Pharmacopoeia, and any official
compendium or any supplement to them

A

Drugs

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25
Q

Any article intended for use in
diagnosis, cure, mitigation, treatment, or
prevention of disease of man or animals;

A

Drugs

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26
Q

Any article, other than food, intended
to affect the structure or any function of
the human body or animals;

A

Drugs

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27
Q

Any article intended for use, as a
component of articles, specified in
clauses (1), (2) and (3), not including
devices or their components, parts and accessories; and

A

Drugs

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28
Q

Herbal or Traditional drugs are defined as?

A

Republic Act No. 9502

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29
Q

Enumerate Sources of Drugs

A

Plant Sources
Animal Sources
Mineral/Earth Sources
Microbiological Sources
Synthetic/ Semi-synthetic sources
Genetic Engineering

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30
Q

Plant materials have served as a
reservoir of potential drugs

A

Plant Sources

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31
Q

Conversion of botanic folklore
remedies into modern wonder drugs

A

Plant Sources

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32
Q

After isolation and structural
identification of active plant
constituents, it maybe recreated by
total synthesis

A

Plant Sources

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33
Q

Make use of the natural chemical as
the starting material and modified
them through molecular manipulation

A

Plant Sources

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34
Q
  • Chemical
    reserpine
  • Tranquilizer
  • Hypotensive
    agent
A

Rauwolfia serpentina

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35
Q
  • Periwinkle
  • Antidiabetic
    agent
  • Antitumor
    activity
A

Vinca rosea

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36
Q
  • Lagundi Leaves
    are considered
    aromatic, bitter,
    anti-inflammatory,
    and bronchial
    smooth muscle
    relaxant
A

Vitex negundo

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37
Q
  • Used to
    treat skin
    infections,
    wounds, dysent
    ery, and urinary
    tract infections
A

Mangostana garcinia

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38
Q

Drug testing and biologic assay

A

Animal Sources

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39
Q

Provided drugs that are mannered from their tissues or through their biologicprocesses

A

Animal Sources

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40
Q

used in treatment of Diabetes.

A

Insulin

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41
Q

used for the treatment of infertility.

A

human chorionic gonadotropin

42
Q

used in hypertension.

A

thyroxin,

43
Q

used as a source of vitamin A and D.

A

Cod Liver

44
Q

a source of pituitary gonadotropins, used in treatment of infertility.

A

Anterior Pituitary

45
Q

used in preparation of vaccines.

A

Blood of animals

46
Q

used in treatment of peptic diseases in the past.

A

Stomach tissue contains pepsin and trypsin,

47
Q

used in treatment of iron deficiency anemia.

A

Iron

48
Q

are used in Syphilis

A

Mercurial salts

49
Q

used as zinc supplement.

A

zinc

50
Q

used in wounds and in eczema.

A

Zinc oxide paste

51
Q

It is antiseptic and can be used as supplements

A

Iodine

52
Q

used in the treatment of rheumatoid
arthritis.

A

Gold Salt

53
Q

used in preparation of liquid paraffin.

A

Petroleum

54
Q

is used in anti dandruff
shampoos.

A

selenium as selenium sulfied

55
Q

Include serums, antitoxins and vaccines

A

Microbiological sources

56
Q

who works on smallpox vaccine during 1796?

A

Edward Genner

57
Q

Poliomyelitis vaccine

A

Renal monkey

58
Q

Mumps & Influenza vaccine-

A

Chick embryo

59
Q

Rubella (German measles) vaccine-

A

Duck embryo

60
Q

is a fungus which gives penicillin.

A

Penicillium notatum

61
Q

give Streptomycin.

A

Actinobacteria

62
Q

are obtained from streptomycis and micromonosporas.

A

Aminoglycosides such as gentamicin and tobramycin

63
Q

When the nucleus of the drug from natural source as well as its
chemical structure is altered

A

Synthetic Drug

64
Q

When the nucleus of drug obtained from natural source is retained but the chemical structure is altered,

A

Semi Synthetic Source

65
Q

Emethic Bismuth Iodide

A

Synthetic Source

66
Q

Apomorphine

A

Semi Synthetic Sources

67
Q

Diacetyl morphine,

A

Semi Synthetic Sources

68
Q

Ethinyl Estradiol,

A

Semi Synthetic Sources

69
Q

Homatropine,

A

Semi Synthetic Sources

70
Q

Ampicillin

A

Semi Synthetic Sources

71
Q

Methyl testosterone.

A

Semi Synthetic Sources

72
Q

Antianxiety drugs and anti convulsant drugs are in what forms?

A

Synthetic forms

73
Q

Recombinant DNA & monoclonal antibody

A

Genetic Engineering

74
Q

GENE THERAPY

A

Genetic Engineering

75
Q

Enumerate two things you could do in genetic engineering?

A

Recombinand DNA and monoclonal antibody
Gene Therapy

76
Q

involves cleavage of DNA by
enzyme restriction endonucleases. The desired gene is
coupled to rapidly replicating DNA (viral, bacterial or
plasmid). The new genetic combination is inserted into the
bacterial cultures which allow production of vast amount of
genetic material.

A

Recombinant DNA & monoclonal antibody

77
Q

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

A

Gene Therapy

78
Q

Enumerate the characteristics of a goal drug

A

 Specifically desired effect,
 Administered by the most desired route (generally orally)
at minimal dosage and dosing frequency
 Optimal onset and duration of activity
 Exhibit no side effects
 Eliminated in the body efficiently and completely
 Low cost
 Pharmaceutically elegant
 Physically & chemically stable

79
Q

Are chemical compounds that show desired biological or
pharmacological activity and may initiate the
development of a new clinically relevant compound.

A

LEAD COMPOUND

80
Q

are typically used as starting points in drug design to give new drug entities.

A

LEAD COMPOUND

81
Q

Drug design strategies can be used to improve the
compound’s pharmacodynamic and pharmacokinetic
properties.

A

Lead compound

82
Q

Treatment IND are sought for to target small number of
patients with rare conditions/diseases (orphan diseases)
where there are no satisfactory alternative treatments

A

Orphan drug

83
Q

Rare disease/condition affecting fewer than 200,000
people:

A

Orphan Disease

84
Q

Enumerate examples of some orphan disease

A

Chronic lymphocytes
Gaucher’s Disease
Leukemia
Cystic Fibrosis Aids

85
Q

as a chemical that is transformed before it has
pharmacological effects.

A

Prodrug

86
Q

Before a prodrug can provide its intended effects in your body,
it needs to be?

A

broken down

87
Q

drug becomes actibe after metabolism

A

Pro drug

88
Q

What are two major types of prodrugs

A

Type I prodrug
Type II prodrug

89
Q

prodrugs turn into their active forms inside of cells.

A

Type I

90
Q

prodrugs turn into their active forms outside of cells, such
as in blood or other fluids.

A

Type II

91
Q

is defined by FDA as an active
ingredient that has never before been marketed in any form.

A

New Molecular Entity (NME)

92
Q

NME

A

New Molecular Entity (NME)

93
Q

A change in a previously approved drug product’s formulation
or method of manufacture constitutes newness under the
law such as changes can alter the therapeutic efficacy
and/or safety of a product.

A

New Molecular Entity (NME)

94
Q

A proposed new use for an established drug, a new dosage
schedule or regimen, a new route of administration, or a
new dosage form makes a drug or a drug product’s status
new and triggers reconsideration for safety and effficacy

A

New Molecular Entity (NME)

95
Q

indicates the number and relationship pf
the atoms in the molecule

A

Empirical formula-

96
Q

name of the compound’s every part of molecular structure

A

Chemical name

97
Q

C16H19N3O3S.3H2O

A

Amoxicillin empirical formula

98
Q

(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-
hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylic acid

A

Amoxicillin Chemical name

99
Q

non-propriety name of the drug, serves to identify the substance to which is applies by means of a
designation that maybe used by the professionals, refers to
the active ingredient of the drug.

A

Generic Name

100
Q

trademarked name/ marketed name assigned by the producing company

A

Brand name

DDS LEC (7 decks)

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