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EDI WOW > MIDTERM 1 TOPIC > Flashcards

MIDTERM 1 TOPIC Flashcards

1
Q

is a valuable component of an effective quality system.

A

QUALITY RISK MANAGEMENT

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2
Q

defined as the combination of the probability of occurrence of harm and the severity of that harm.

A

RISK

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3
Q

Risk is commonly defined as the combination of the probability of occurrence of _____ and the _____ of that harm.

A

HARM, SEVERITY

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4
Q

50-200 healthy subjects (usualy) or patients who are not expected to benefit from the IMP

A

PHASE 1

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5
Q

100-400 patients with the target disease.

A

PHASE 2

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6
Q

1000-5000 patients with the target disease

A

PHASE 3

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7
Q

Many thousands or millions of patients with the target disease

A

PHASE 4

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8
Q

It is important to understand that product ______ is assured based on appropriate risk based decision-making throughout the product lifecycle, such that the attributes that are important to the quality of the drug (medicinal) product are maintained and the product remains safe and effective.

A

QUALITY

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9
Q

It is important to understand that product quality is assured based on appropriate risk based _____ throughout the ______, such that the attributes that are important to the quality of the drug (medicinal) product are maintained and the product remains safe and effective.

A

DECISION-MAKING
PRODUCT LIFECYCLE

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10
Q

is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.

A

QUALITY RISK MANAGEMENT

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11
Q

Quality Risk Management is a systematic process for the _____, _____,______ and _______ to the quality of the drug (medicinal) product across the product lifecycle.

A

ASSESSMENT, CONTROL, COMMUNICATION , REVIEW OF RISK

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12
Q

3 Risk Assessment

A

HAZARD IDENTIFICATION
RISK ANALYSIS
RISK EVALUATION

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13
Q

2 Risk Control

A

RISK REDUCTION
RISK ACCEPTANCE

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14
Q

The purpose of ________ is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

A

STABILITY TESTING

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15
Q

3 environmental factors of stability testing

A

TEMPERATURE
HUMIDITY
LIGHT

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16
Q

different in all the countries in the world.

A

CLIMATE

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17
Q

Stability studies of the pharmaceutical drug should be done according to the
______ conditions of the country.

A

CLIMATE

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18
Q

According to the ICH guidelines for stability studies, the climate of the world is divided into _____ different zones.

A

FIVE

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19
Q

According to the ICH guidelines for stability studies, the climate of the world is divided into ____ different zones.

A

FIVE

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20
Q

According to the ICH guidelines for stability studies, the climate of the world is divided into ____ different zones.

A

FIVE

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21
Q

Temperate zone

A

ZONE I

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22
Q

Temperate zone

A

ZONE I

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23
Q

Mediteranean/subtropical zone

A

ZONE II

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24
Q

Hot dry zone

A

ZONE III

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25
Q

Hot humid/tropical zone

A

ZONE IVa

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26
Q

Hot/higher humdity

A

ZONE IVb

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27
Q

can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.

A

STRESS TESTING

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28
Q

testing should be an integral part of stress testing.

A

PHOTOSTABILITY

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29
Q

Data from formal stability studies should be provided on at least _____ of the drug substance.

A

THREE PRIMARY BATCHES

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30
Q

should be conducted on the drug substance packaged in a container closure system that is the same as or simulates the packaging proposed for storage and distribution.

A

STABILITY STUDIES

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31
Q

The long-term testing should be performed over a minimum of ____ months at 25 ° C ± 2 °C/60% RH ± 5% RH or at 30 °C ± 2 °C/65% RH ± 5% RH.

A

12

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32
Q

In general, a drug substance should be evaluated under ________ (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture

A

STORAGE CONDITIONS

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33
Q

The ______ and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use.

A

STORAGE CONDITION

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34
Q

defined as failure to meet its specification.

A

SIGNIFICANT CHANGE

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35
Q

_____ of pharmaceutical formulations is an essential operation in the production of drugs.

A

QUALITY CONTROL

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36
Q

It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.

A

QUALITY CONTROL

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37
Q

different types of dosage forms:

A

SOLID DOSAGE FORM
LIQUID DOSAGE FORM
SEMI-SOLID DOSAGE FORM
GAS DOSAGE FORM

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38
Q

______ means a physical form by which drug molecules are delivered into the site of action.

A

DOSAGE FORM

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39
Q

are the most commonly used dosage form because of the stability and ease of mass production.

A

SOLID DOSAGE FORM

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40
Q

which are solid in nature which contain one or more drugs for therapeutic effects and excipients like Binders, Sweeteners, coloring agents, etc.

A

SOLID DOSAGE FORMS

41
Q

Examples of Solid Dosage Form:

A

TABLETS
CAPSULES
GRANULES
SACHETS
POWDERS
DRY POWDERS
INHALERS
CHEWABLE

42
Q

•More stable than other dosage forms.
• Easy to handle.
• More accurate of the dosage form.
• No preservation required.

A

ADVANTAGES OF SOLID DOSAGE FORMS

43
Q

• Expensive Machines.
• Tough to swallow for kids and patients in sleeping condition.

A

DISADVANTAGES OF SOLID DOSAGE FORMS

44
Q

• Tablets
• Capsules
• Granules
• Sachets
• Lozenges
• Pills
• Dry powder inhaler
• Chewables

A

UNIT DOSE

45
Q

• Powder (External and Internal)

A

BULK DOSE

46
Q

It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.

A

QUALITY CONTROL

47
Q

It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.

A

QUALITY CONTROL

48
Q

compressed solid dosage form contain therapeutic active ingredients and excipients.

A

TABLET

49
Q

are solid dosage forms where the therapeutic active ingredient granules are enclosed within a hard or soft soluble shell.

A

CAPSULES

50
Q

are solid dosage forms made up of agglomeration of smaller particles of powders.

A

GRANULES

51
Q

are solid dosage forms containing therapeutic ingredients. Small size spherical granules packed into a small bag or pouch packet.

A

SACHETS

52
Q

are the solid dosage form that dissolves slowly into the mouth.

A

LOZENGES

53
Q

contain a drug along with flavoring and sweetening agents.

A

LOZENGES

54
Q

Are the solid dosage forms that are best or most easily absorbed by chewing.

A

CHEWABLE

55
Q

_________are those materials which are used in every dosage form.

A

EXCIPIENTS

56
Q

_________ are those materials which are used in every dosage form. But it doesn’t have any therapeutic effects or side effects.

A

EXCIPIENTS

57
Q

to make the plasticity in the tablet formulation.

A

BINDERS OR BINDING AGENTS

58
Q

it helps to maintain the inter-particle bonding strength and to achieve mechanical strength and sometimes for the drug release properties.

A

BINDERS OR BINDING AGENT

59
Q

Starch, gelatin, acacia, tragacanth.

A

NATURAL POLYMERS

60
Q

4 Natural Polymers:

A

STARCH
GELATIN
ACACIA
TRAGACANTH

61
Q

Hydroxypropyl methylcellulose (HPMC), Methyl cellulose, Ethylcellulose, Polyethylene glycol (PEG).

A

SYNTHETIC POLYMER

62
Q

Glucose, Sucrose, Sorbitol

A

SUGAR

63
Q

3 Sugar:

A

GLUCOSE
SUCROSE
SORBITOL

64
Q

Used in tablet preparation. The role of the _______ is protecting the drug from environmental moisture, light, or the acidic environment of the stomach and it also masks the bitter taste of many drugs.

A

COATING AGENT

65
Q

3 types of Coating Agents:

A

SUGAR COATING
FILM COATING
ENTERIC COATING

66
Q

used to protect the formulation from the attack of microorganisms. Such as bacterial growth, fungus growth, etc.

A

PRESERVATIVES

67
Q

Phenol, parabens, aryl and alkyl acids, etc.

A

PRESERVATIVES

68
Q

used to giving an attractive outlook for the patients.

A

COLORING AGENTS

69
Q

Turmeric, Titanium Dioxide, etc.

A

NATURAL COLORS

70
Q

Erythrosine, Tartrazine, etc.

A

SYNTHETIC COLORS

71
Q

used in basically chewable tablets. To cover up the unpleasant taste of the tablet or any pharmaceutical formulation.

A

SWEETENING AGENTS

72
Q

Sucrose, fructose, etc

A

SWEETENING AGENTS

73
Q

constitute a significant proportion of pharmaceutical dosage forms. They serve as carriers for drugs that are topically delivered by way of the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining.

A

SEMI-SOLID DOSAGE FORM

74
Q

__________ are normally presented in the form of creams, gels, ointments, or pastes.

A

TOPICSL SEMI-SOLID DOSAGE FORMS

75
Q

They contain one or more active ingredients dissolved or uniformly dispersed in a suitable base and any suitable excipients such as emulsifiers, viscosity increasing agents, anti microbial agents, antioxidants’, or stabilizing agents.

A

TOPICAL SEMI-SOLID DOSAGE FORM

76
Q

contain very limited quantities of a liquid or aqueous phase

A

SEMI-SOLID DOSAGE FORMS

77
Q

can be measured by using a simple pH meter or by using a probe-type pH meter.

A

SURFACE PH

78
Q

are plastic in behavior hence they retain their shape on application of outside force.

A

SEMI-SOLID DOSAGE FORM

79
Q

are homogenous, semi-solid preparations intended for external application to the skin or mucous membrane.

A

OINTMENTS

80
Q

They are used as emollients or for the application of active ingredients to the skin for protective, therapeutic, or prophylactic purpose and where a degree of occlusion is desired.

A

OINTMENTS

81
Q

Their composition softens but does not melt upon application to the skin. Therapeutically, ______ function as skin protectives and emollients, but they are used primarily as vehicles for the topical application of drug substances.

A

OINTMENT

82
Q

usually anhydrous and can absorb only small amounts of water. Typical bases used for their formulation are water-insoluble hydrocarbons such as hard, soft and liquid paraffin, vegetable oil, animal fats, waxes, synthetic glycerides and polyalkyl siloxanes.

A

HYDROPHOBIC (LIPOPHILIC) OINTMENTS

83
Q

can absorb large amounts of water. They typically consist of a hydrophobic fatty base in which a w/o agent, such as wool fat, wool alcohols, sorbitan esters, mono glycerides, or fatty alcohols can be incorporated to render them hydrophilic. They may also be w/o emulsions that allow additional quantities of aqueous solutions to be incorporated. Such ointments are used especially when formulating aqueous liquids or solutions.

A

WATER-EMULSIFYING OINTMENTS

84
Q

are miscible with water. The bases are usually mixture of liquid and solid polyethylene glycols (macrogols).

A

HUDROPHILIC OINTMENTS

85
Q

are homogeneous, semi-solid preparations consisting of opaque emulsion systems.

A

CREAMS

86
Q

Their consistency and rheological properties depend on the type of emulsion, either water-in-oil (w/o) or oil-in –water (o/w), and on the nature of the solids in the internal phase. _______ are intended for the application to the skin or certain mucous membranes for protective, therapeutic, or prophylactic purposes, especially where an occlusive effect is not necessary.

A

CREAMS

87
Q

are semisolid dosage forms that contain one or more drug substances dissolved or dispersed in a suitable base, usually oil in- water emulsion or aqueous microcrystalline dispersion of long-chain fatty acids or alcohols that are water washable and are cosmetically and aesthetically acceptable.

A

CREAMS

88
Q

homogeneous, clear, semi-solid preparation consisting of a liquid phase within a three-dimensional polymeric matrix with physical or sometimes chemical cross linkage by means of suitable gelling agents.

A

GELS

89
Q

are semisolid systems that consist of either suspensions of small inorganic particles or large organic molecules interpenetrated by a liquid.

A

GELS

90
Q

bases usually consist of liquid paraffin with polyethylene or fatty oils gelled with colloidal silica or aluminium or zinc soaps.

A

HYDROPHOBIC GELS

91
Q

bases usually consist of water, glycerol, or propylene glycol gelled with suitable agents such as tragacanth, starch, cellulose derivatives, carboxyvinyl polymers, and magnesium aluminium silicates.

A

HYDROPHILIC GELS (HYDROGEL)

92
Q

homogeneous, semi-solid preparations containing high concentrations of insoluble powdered substances (usually not less than 20%) dispersed in a suitable base.

A

PASTES

93
Q

The _______ are usually less greasy, more absorptive, and stiffer in consistency than ointments because of the large quantity of powdered ingredients present. Some pastes consist of a single phase, such as hydrated pectin, and others consist of a thick, rigid material that does not flow at body temperature. The pastes should adhere well to the skin. In many cases they form a protective film that controls the evaporation of water.

A

PASTES

94
Q

are semisolid dosage forms that contain one or more drug substances incorporated in a base with large proportions of finely dispersed solids.

A

PASTES

95
Q

is an ancient form of topical medication also known as a cataplasma.

A

POULTICES

96
Q

Poultices is an ancient form of topical medication also known as a ______.

A

CATAPLASMA

97
Q

It is a soft mass of vegetable constituents or clay, usually heated before application.

A

POULTICE

98
Q

It is prepared by mixing and heating dried, heavy kaolin and boric acid with glycerine. After cooling, the aromatic substances are incorporated with stirring. The product is spread on a dressing and applied hot to the skin.

A

KAOLIN POULTICE (BP)

EDI WOW (8 decks)

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