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PH 107 - Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices (Lec.) > PRELIM 02 - Drug Development Process > Flashcards

PRELIM 02 - Drug Development Process Flashcards

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USMLE® Step 1 flashcards
1
Q

Is an article/agent used in diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals

A

Drug

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2
Q

Dosage formulations used for clinical evaluation of a new drug

A

Clinical Drug Materials (CDM)

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3
Q

Promotes the right and safety of the subjects

A

Investigational New Drug (IND)

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4
Q

Gains permission to market the drug product

A

New Drug Application (NDA)

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5
Q

Application by the sponsor of approved NDA to make changes

A

Supplemental New Drug Application (SNDA)

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6
Q

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

A

Abbreviated New Drug Application (ANDA)

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7
Q

Manufacture of biological such as blood products, vaccines, and toxins

A

Biologics License Application (BLA)

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8
Q

Brings together regulatory requirements

A

International Conference on Harmonization (ICH)

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9
Q

Active ingredient/component that produces pharmacologic activity

A

Drugs substance

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10
Q

Drug substance with unknown clinical, toxicologic, physical, and chemical properties

A

New Chemical Entity (NCE)

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11
Q

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

A

Drug product

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12
Q

6 sources of drugs

A

Plant, Animal, Mineral/Earth, Microbiological, Synthetic/Semi-synthetic, Genetic engineering

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13
Q

Have served as a reservoir of potential drugs (Sources of drugs)

A

Plant sources

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14
Q

Used as a tranquilizer and hypotensive agent

A

Rauwolfia serpentina

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15
Q

Used as an antidiabetic agent and for its antitumor activity

A

Vinca rosea

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16
Q

Are considered aromatic, bitter, anti-inflammatory, and bronchial smooth muscle relaxant

A

Vitex negundo

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17
Q

Used to treat skin infections, wounds, dysentery, and urinary tract infections

A

Mangostana garcinia

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18
Q

Provided drugs that are mannered from animal tissues or through their biologic processes (Sources of drugs)

A

Animal sources

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19
Q

Pancreas is a source of __________, used to treat diabetes (Animal sources)

A

Insulin

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20
Q

Urine of pregnant woman gives __________, used for the treatment of infertility (Animal sources)

A

Human chorionic gonadotropin (hCG)

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21
Q

Sheep thyroid is a source of __________, used in hypertension (Animal sources)

A

Thyroxin

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22
Q

Cod liver is used as a source of __________ and __________ (Animal sources)

A

Vitamin A, Vitamin D

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23
Q

Anterior pituitary is a source of __________, used in the treatment of infertility (Animal sources)

A

Pituitary gonadotropins

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24
Q

Stomach tissue contains __________ and __________, which are digestive juices used in the treatment of peptic diseases in the past (Animal sources)

A

Pepsin, Trypsin

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25
Q

Is used in the treatment of iron deficiency anemia (Mineral/Earth sources)

A

Iron

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26
Q

Are salts used in syphilis (Mineral/Earth sources)

A

Mercurial salts

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27
Q

Is used as a zinc supplement (Mineral/Earth sources)

A

Zinc

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28
Q

Is a paste used in wounds and in eczema (Mineral/Earth sources)

A

Zinc oxide paste

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29
Q

Is used as an antiseptic (Mineral/Earth sources)

A

Iodine

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30
Q

Are used in the treatment of rheumatoid arthritis (Mineral/Earth sources)

A

Gold salts

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31
Q

Has antiseptic properties (Mineral/Earth sources)

A

Fluorine

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32
Q

Has antiseptic properties as well, same as fluorine (Mineral/Earth sources)

A

Borax

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33
Q

Is used in anti-dandruff shampoos (Mineral/Earth sources)

A

Selenium (Selenium sulfide)

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34
Q

Is used in the preparation of liquid paraffin (Mineral/Earth sources)

A

Petroleum

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35
Q

Includes serums, antitoxins, and vaccines (Sources of drugs)

A

Microbiological sources

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36
Q

Year when Edward Genner worked on the smallpox vaccine

A

1796

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37
Q

From renal monkey (Microbiological sources)

A

Poliomyelitis vaccine

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38
Q

From chick embryo (Microbiological sources)

A

Mumps & influenza vaccine

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39
Q

From duck embryo (Microbiological sources)

A

Rubella (German measles) vaccine

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40
Q

Is a fungus which gives penicillin (Microbiological sources)

A

Penicillium notatum

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41
Q

Gives streptomycin (Microbiological sources)

A

Actinobacteria

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42
Q

Aminoglycosides such as gentamicin and tobramycin are obtained from __________ and __________ (Microbiological sources)

A

Streptomycis, Micromonosporas

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43
Q

Type of source when the nucleus of the drug from natural source as well as its chemical structure is altered (Synthetic/Semi-synthetic sources)

A

Synthetic sources

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44
Q

Type of source when the nucleus of the drug obtained from natural source is retained but the chemical structure is altered (Synthetic/Semi-synthetic sources)

A

Semi-synthetic sources

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45
Q

Is a medical intervention based on the modification of the genetic material of living cells (Genetic engineering)

A

Gene therapy

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46
Q

Involved cleavage of DNA by enzyme restriction endonucleases (Genetic engineering)

A

Recombinant DNA technology

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47
Q

A drug that would produce the specifically desired effect

A

Goal drug

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48
Q

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

A

Lead compound

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49
Q

A chemical that is transformed before it has pharmacological effects

A

Prodrug

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50
Q

2 major types of prodrugs

A

Type I, Type II

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51
Q

Type of prodrug that turn into their active forms inside of cells

A

Type I prodrug

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52
Q

Type of prodrug that turn into their active forms outside of cells

A

Type II prodrug

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53
Q

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

A

New molecular entity (NME)

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54
Q

Indicated the number and relationship of the atoms in the molecule (Drug nomenclature)

A

Empirical formula

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55
Q

Name of the compound’s every part of molecular structure (Drug nomenclature)

A

Chemical name

56
Q

Non-proprietary name of the drug; refers to the active ingredient of the drug (Drug nomenclature)

A

Generic name

57
Q

Trademarked name/Marketed name assigned by the producing company (Drug nomenclature)

A

Brand name

58
Q

Treatment that are sought for to target small number of patients with rare conditions/diseases

A

Orphan drug

59
Q

Rare disease/condition affecting fewer than 200,000 people

A

Orphan disease

60
Q

5 examples of orphan disease

A

Chronic lymphocytes, Leukemia, Gaucher’s disease, Cystic fibrosis, AIDS

61
Q

Concerned with drugs, their sources, appearance, chemistry, action, and uses

A

Pharmacology

62
Q

Is a science that studies the biochemical and physiologic effects of a drug and its organ-specific mechanism of action, including effects on the cellular level

A

Pharmacodynamics

63
Q

Is the science that analyzes how the human body interacts with a drug

A

Pharmacokinetics

64
Q

The primary objective of __________ is to obtain basic information on the drugs’ effects that maybe safe and effective use in humans

A

Animal studies

65
Q

Done in dogs and rats (Animal studies)

A

Hypertensive studies

66
Q

Done in dogs and guinea pigs (Animal studies)

A

Respiratory effects studies

67
Q

Done in dogs (Animal studies)

A

Diuretic activities

68
Q

Done in rabbits (Animal studies)

A

Blood coagulation

69
Q

Done in mice and rabbits (Animal studies)

A

Central nervous system studies

70
Q

Involves those chemical processes within living organisms to maintain life

A

Drug metabolism

71
Q

Transit through the liver and exposure to the hepatic enzyme system

A

1st pass effect

72
Q

Performed through the collection and analysis of urine, blood and feces samples, and careful exam

A

ADME studies

73
Q

Deals with the adverse or undesired effects of drugs

A

Toxicology

74
Q

Studies the toxic effect of a test compound when administered in single dose or multiple doses over a short period (Different studies in toxicological profile)

A

Acute/short term toxicity studies

75
Q

Considered: the relationship to projected human clinical studies for safety (Different studies in toxicological profile)

A

Subacute/subchronic studies

76
Q

Drugs intended to be given to humans for a week or more, animal studies of 90-180 days in length must demonstrate safety (Different studies in toxicological profile)

A

Chronic toxicity studies

77
Q

Long term studies (18-24 months) with surviving animals killed and studied at defined weeks during the test period (Different studies in toxicological profile)

A

Carcinogenicity studies

78
Q

Reveals any effect of an active ingredient on mammalian reproduction (Different studies in toxicological profile)

A

Reproduction studies

79
Q

Determines whether test compound affects gene mutation or cause chromosome or DNA damage (Different studies in toxicological profile)

A

Genetoxicity/mutagenecity studies

80
Q

Is a measure of its distribution in a lipophilic-hydrophilic phase system and indicates its ability to penetrate biological multiphase system

A

Partition coefficient

81
Q

Speed/rate at which a drug substance dissolved in a medium

A

Dissolution rate

82
Q

Part of the IND application; submitted to ensure the appropriate design and conduct of investigation

A

Clinical protocol

83
Q

Stage where animal pharmacology and toxicology data are obtained (Phases of product development)

A

Preclinical stage

84
Q

Stage which is the initial introduction and includes 20-100 healthy volunteers (Phases of product development)

A

Phase I

85
Q

Stage where controlled clinical studies to several hundred patients with the disease/condition are treated (Phases of product development)

A

Phase II

86
Q

Phase where several hundred to several thousand patients with the disease/condition treated for which the drug was developed (Phases of product development)

A

Phase III

87
Q

Phase where completed studies are sufficient for the NDA (Phases of product development)

A

Phase 3a

88
Q

Phase where additional studies are used to gather supplemental information to support certain labelling requests (Phases of product development)

A

Phase 3b

89
Q

Phase which has continual clinical investigation and manufacturing scale-up activities (Phases of product development)

A

Phase IV

90
Q

Phase where product development continues after the FDA’s market approval of the product (Phases of product development)

A

Phase V (Post marketing surveillance)

91
Q

Is required to report to the FDA each adverse drug experience that is both serious and unexpected

A

Drug sponsor

92
Q

Letter for approval of the application permitting marketing

A

Approval letter

93
Q

Letter for one or more deficiencies

A

Non-approvable letter

94
Q

Derived from biological assay methods; reflects drug’s potency

A

Units of activity

95
Q

Determines minimum concentration expected to produce the drug’s desired effects in a patient

A

Minimum effective concentration (MEC)

96
Q

Above the average blood serum concentration level producing toxic effects

A

Minimum toxic concentration (MTC)

97
Q

Produces the desired intensity of effect in 50% of the individuals tested

A

ED50/Median effective dose

98
Q

Produces a defined toxic effect in 50% of the individuals tested

A

TD50/Median toxic dose

99
Q

Ratio of drug’s median toxic dose and median effective dose

A

Therapeutic index

100
Q

Regularly schedule subsequent administration to keep the most desirable concentration of drug in the blood

A

Maintenance dosage

101
Q

Required to attain desired concentration of the drug in the blood of tissues

A

Initial priming/loading dose

102
Q

Protects the patient from contracting the illness

A

Prophylactic dose

103
Q

Administered to the patient after exposure or contraction of the illness

A

Therapeutic dose

104
Q

Effect of drug modified by prior/concurrent administration of another drug

A

Drug-drug interaction

105
Q

3 general areas being focused on by the International Conference on Harmonization (ICH)

A

Quality, Safety, Efficacy

106
Q

Stability, light stability, analytical validation, impurities and biotechnology (General areas of ICH)

A

Quality topics

107
Q

Carcinogenicity, genotoxicity, toxicokinetics, reproduction toxicity, and single and repeat dose toxicity (General areas of ICH)

A

Safety topics

108
Q

Population exposure, managing clinical trials, clinical study reports, dose response, ethnic factors, and good clinical practices and geriatrics (General areas of ICH)

A

Efficacy topics

109
Q

Established by the Food and Drug Administration (FDA) to ensure the minimum standards are met for drug product quality

A

Current Good Manufacturing Practice (cGMP)

110
Q

Holds the article and is or maybe in direct contact with the article

A

Container

111
Q

Is a container that it is in direct contact with the article at all times

A

Immediate container

112
Q

Is a container that protects the contents from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution

A

Well-closed container

113
Q

Is a container that protects the contents from the contamination by extraneous liquids, solids, or vapors

A

Tight container

114
Q

Is a container that is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution

A

Hermetic container

115
Q

Is a container that holds a quantity of drug intended as a single dose

A

Single-dose container

116
Q

Is a container that permits withdrawal of successive portions of the contents

A

Multiple-dose container

117
Q

Is a container designed to hold a quantity of drug intended for administration as a single dose promptly after the container is opened

A

Single-unit container

118
Q

A single-unit package is termed a __________

A

Unit dose package

119
Q

Is a container that contain more than a single unit or dose of the medication

A

Multiple-unit container

120
Q

Highly resistant borosilicate glass (Official glass types)

A

Type I

121
Q

Treated soda lime glass (Official glass types)

A

Type II

122
Q

Soda lime glass (Official glass types)

A

Type III

123
Q

General purpose soda lime glass (Official glass types)

A

Type NP

124
Q

3 examples of plastic materials

A

PET, APET, PETG

125
Q

Meaning of PET

A

Polyethylene terephthalate

126
Q

Meaning of APET

A

Amorphous polyethylene terephthalate glycol

127
Q

Meaning of PETG

A

Polyethylene terephthalate glycol

128
Q

2 plastic materials that has excellent transparency and luster and can be sterilized with gamma radiation

A

APET, PETG

129
Q

A term used to describe the movement of components of a container into the contents

A

Leaching

130
Q

A term used to indicate the binding of molecules to polymer materials, which includes both absorption and adsorption

A

Sorption

131
Q

Not exceeding 8°C (Storage description)

A

Cold

132
Q

Temperature range of refrigerator

A

2 to 8°C

133
Q

Temperature range of freezer

A

-25 to -10°C

134
Q

Between 8°C and 15°C (Storage description)

A

Cool

135
Q

Between 20°C and 25°C (Storage description)

A

Room temperature

136
Q

Between 30°C and 40°C (Storage description)

A

Warm

137
Q

Above 40°C (Storage description)

A

Excessive heat

PH 107 - Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices (Lec.) (13 decks)

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