MIDTERM 1 TOPIC

Question 1

is a valuable component of an effective quality system.

Answer 1

QUALITY RISK MANAGEMENT

Question 2

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

Answer 2

RISK

Question 3

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

Answer 3

HARM, SEVERITY

Question 4

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

Answer 4

PHASE 1

Question 5

100-400 patients with the target disease.

Answer 5

PHASE 2

Question 6

1000-5000 patients with the target disease

Answer 6

PHASE 3

Question 7

Many thousands or millions of patients with the target disease

Answer 7

PHASE 4

Question 8

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.

Answer 8

QUALITY

Question 9

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.

Answer 9

DECISION-MAKING
PRODUCT LIFECYCLE

Question 10

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.

Answer 10

QUALITY RISK MANAGEMENT

Question 11

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

Answer 11

ASSESSMENT, CONTROL, COMMUNICATION , REVIEW OF RISK

Question 12

3 Risk Assessment

Answer 12

HAZARD IDENTIFICATION
RISK ANALYSIS
RISK EVALUATION

Question 13

2 Risk Control

Answer 13

RISK REDUCTION
RISK ACCEPTANCE

Question 14

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.

Answer 14

STABILITY TESTING

Question 15

3 environmental factors of stability testing

Answer 15

TEMPERATURE
HUMIDITY
LIGHT

Question 16

different in all the countries in the world.

Answer 16

CLIMATE

Question 17

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

Answer 17

CLIMATE

Question 18

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

Answer 18

FIVE

Question 19

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

Answer 19

FIVE

Question 20

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

Answer 20

FIVE

Question 21

Temperate zone

Answer 21

ZONE I

Question 22

Temperate zone

Answer 22

ZONE I

Question 23

Mediteranean/subtropical zone

Answer 23

ZONE II

Question 24

Hot dry zone

Answer 24

ZONE III

Question 25

Hot humid/tropical zone

Answer 25

ZONE IVa

Question 26

Hot/higher humdity

Answer 26

ZONE IVb

Question 27

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.

Answer 27

STRESS TESTING

Question 28

testing should be an integral part of stress testing.

Answer 28

PHOTOSTABILITY

Question 29

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

Answer 29

THREE PRIMARY BATCHES

Question 30

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.

Answer 30

STABILITY STUDIES

Question 31

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.

Answer 31

12

Question 32

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

Answer 32

STORAGE CONDITIONS

Question 33

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

Answer 33

STORAGE CONDITION

Question 34

defined as failure to meet its specification.

Answer 34

SIGNIFICANT CHANGE

Question 35

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

Answer 35

QUALITY CONTROL

Question 36

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

Answer 36

QUALITY CONTROL

Question 37

different types of dosage forms:

Answer 37

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

Question 38

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

Answer 38

DOSAGE FORM

Question 39

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

Answer 39

SOLID DOSAGE FORM

Question 40

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

Answer 40

SOLID DOSAGE FORMS

Question 41

Examples of Solid Dosage Form:

Answer 41

TABLETS CAPSULES GRANULES SACHETS POWDERS DRY POWDERS INHALERS CHEWABLE

Question 42

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

Answer 42

ADVANTAGES OF SOLID DOSAGE FORMS

Question 43

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

Answer 43

DISADVANTAGES OF SOLID DOSAGE FORMS

Question 44

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

Answer 44

UNIT DOSE

Question 45

• Powder (External and Internal)

Answer 45

BULK DOSE

Question 46

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

Answer 46

QUALITY CONTROL

Question 47

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

Answer 47

QUALITY CONTROL

Question 48

compressed solid dosage form contain therapeutic active ingredients and excipients.

Answer 48

TABLET

Question 49

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

Answer 49

CAPSULES

Question 50

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

Answer 50

GRANULES

Question 51

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

Answer 51

SACHETS

Question 52

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

Answer 52

LOZENGES

Question 53

contain a drug along with flavoring and sweetening agents.

Answer 53

LOZENGES

Question 54

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

Answer 54

CHEWABLE

Question 55

_________are those materials which are used in every dosage form.

Answer 55

EXCIPIENTS

Question 56

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

Answer 56

EXCIPIENTS

Question 57

to make the plasticity in the tablet formulation.

Answer 57

BINDERS OR BINDING AGENTS

Question 58

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

Answer 58

BINDERS OR BINDING AGENT

Question 59

Starch, gelatin, acacia, tragacanth.

Answer 59

NATURAL POLYMERS

Question 60

4 Natural Polymers:

Answer 60

STARCH GELATIN ACACIA TRAGACANTH

Question 61

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

Answer 61

SYNTHETIC POLYMER

Question 62

Glucose, Sucrose, Sorbitol

Answer 62

SUGAR

Question 63

3 Sugar:

Answer 63

GLUCOSE SUCROSE SORBITOL

Question 64

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.

Answer 64

COATING AGENT

Question 65

3 types of Coating Agents:

Answer 65

SUGAR COATING FILM COATING ENTERIC COATING

Question 66

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

Answer 66

PRESERVATIVES

Question 67

Phenol, parabens, aryl and alkyl acids, etc.

Answer 67

PRESERVATIVES

Question 68

used to giving an attractive outlook for the patients.

Answer 68

COLORING AGENTS

Question 69

Turmeric, Titanium Dioxide, etc.

Answer 69

NATURAL COLORS

Question 70

Erythrosine, Tartrazine, etc.

Answer 70

SYNTHETIC COLORS

Question 71

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

Answer 71

SWEETENING AGENTS

Question 72

Sucrose, fructose, etc

Answer 72

SWEETENING AGENTS

Question 73

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.

Answer 73

SEMI-SOLID DOSAGE FORM

Question 74

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

Answer 74

TOPICSL SEMI-SOLID DOSAGE FORMS

Question 75

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.

Answer 75

TOPICAL SEMI-SOLID DOSAGE FORM

Question 76

contain very limited quantities of a liquid or aqueous phase

Answer 76

SEMI-SOLID DOSAGE FORMS

Question 77

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

Answer 77

SURFACE PH

Question 78

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

Answer 78

SEMI-SOLID DOSAGE FORM

Question 79

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

Answer 79

OINTMENTS

Question 80

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.

Answer 80

OINTMENTS

Question 81

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.

Answer 81

OINTMENT

Question 82

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.

Answer 82

HYDROPHOBIC (LIPOPHILIC) OINTMENTS

Question 83

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.

Answer 83

WATER-EMULSIFYING OINTMENTS

Question 84

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

Answer 84

HUDROPHILIC OINTMENTS

Question 85

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

Answer 85

CREAMS

Question 86

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.

Answer 86

CREAMS

Question 87

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.

Answer 87

CREAMS

Question 88

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.

Answer 88

GELS

Question 89

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

Answer 89

GELS

Question 90

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

Answer 90

HYDROPHOBIC GELS

Question 91

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.

Answer 91

HYDROPHILIC GELS (HYDROGEL)

Question 92

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

Answer 92

PASTES

Question 93

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.

Answer 93

PASTES

Question 94

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

Answer 94

PASTES

Question 95

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

Answer 95

POULTICES

Question 96

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

Answer 96

CATAPLASMA

Question 97

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

Answer 97

POULTICE

Question 98

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.

Answer 98

KAOLIN POULTICE (BP)