PRELIM 02 - Drug Development Process 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
2
Q
Dosage formulations used for clinical evaluation of a new drug
A
Clinical Drug Materials (CDM)
3
Q
Promotes the right and safety of the subjects
A
Investigational New Drug (IND)
4
Q
Gains permission to market the drug product
A
New Drug Application (NDA)
5
Q
Application by the sponsor of approved NDA to make changes
A
Supplemental New Drug Application (SNDA)
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)
7
Q
Manufacture of biological such as blood products, vaccines, and toxins
A
Biologics License Application (BLA)
8
Q
Brings together regulatory requirements
A
International Conference on Harmonization (ICH)
9
Q
Active ingredient/component that produces pharmacologic activity
A
Drugs substance
10
Q
Drug substance with unknown clinical, toxicologic, physical, and chemical properties
A
New Chemical Entity (NCE)
11
Q
Finished dosage form (containing the drug subs + other excipients/inert substances)
A
Drug product
12
Q
6 sources of drugs
A
Plant, Animal, Mineral/Earth, Microbiological, Synthetic/Semi-synthetic, Genetic engineering
13
Q
Have served as a reservoir of potential drugs (Sources of drugs)
A
Plant sources
14
Q
Used as a tranquilizer and hypotensive agent
A
Rauwolfia serpentina
15
Q
Used as an antidiabetic agent and for its antitumor activity
A
Vinca rosea
16
Q
Are considered aromatic, bitter, anti-inflammatory, and bronchial smooth muscle relaxant
A
Vitex negundo
17
Q
Used to treat skin infections, wounds, dysentery, and urinary tract infections
A
Mangostana garcinia
18
Q
Provided drugs that are mannered from animal tissues or through their biologic processes (Sources of drugs)
A
Animal sources
19
Q
Pancreas is a source of __________, used to treat diabetes (Animal sources)
A
Insulin
20
Q
Urine of pregnant woman gives __________, used for the treatment of infertility (Animal sources)
A
Human chorionic gonadotropin (hCG)
21
Q
Sheep thyroid is a source of __________, used in hypertension (Animal sources)
A
Thyroxin
22
Q
Cod liver is used as a source of __________ and __________ (Animal sources)
A
Vitamin A, Vitamin D
23
Q
Anterior pituitary is a source of __________, used in the treatment of infertility (Animal sources)
A
Pituitary gonadotropins
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
25
Is used in the treatment of iron deficiency anemia (Mineral/Earth sources)
Iron
26
Are salts used in syphilis (Mineral/Earth sources)
Mercurial salts
27
Is used as a zinc supplement (Mineral/Earth sources)
Zinc
28
Is a paste used in wounds and in eczema (Mineral/Earth sources)
Zinc oxide paste
29
Is used as an antiseptic (Mineral/Earth sources)
Iodine
30
Are used in the treatment of rheumatoid arthritis (Mineral/Earth sources)
Gold salts
31
Has antiseptic properties (Mineral/Earth sources)
Fluorine
32
Has antiseptic properties as well, same as fluorine (Mineral/Earth sources)
Borax
33
Is used in anti-dandruff shampoos (Mineral/Earth sources)
Selenium (Selenium sulfide)
34
Is used in the preparation of liquid paraffin (Mineral/Earth sources)
Petroleum
35
Includes serums, antitoxins, and vaccines (Sources of drugs)
Microbiological sources
36
Year when Edward Genner worked on the smallpox vaccine
1796
37
From renal monkey (Microbiological sources)
Poliomyelitis vaccine
38
From chick embryo (Microbiological sources)
Mumps & influenza vaccine
39
From duck embryo (Microbiological sources)
Rubella (German measles) vaccine
40
Is a fungus which gives penicillin (Microbiological sources)
Penicillium notatum
41
Gives streptomycin (Microbiological sources)
Actinobacteria
42
Aminoglycosides such as gentamicin and tobramycin are obtained from __________ and __________ (Microbiological sources)
Streptomycis, Micromonosporas
43
Type of source when the nucleus of the drug from natural source as well as its chemical structure is altered (Synthetic/Semi-synthetic sources)
Synthetic sources
44
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)
Semi-synthetic sources
45
Is a medical intervention based on the modification of the genetic material of living cells (Genetic engineering)
Gene therapy
46
Involved cleavage of DNA by enzyme restriction endonucleases (Genetic engineering)
Recombinant DNA technology
47
A drug that would produce the specifically desired effect
Goal drug
48
A prototype chemical compound that has fundamental desired biologic or pharmacologic activity
Lead compound
49
A chemical that is transformed before it has pharmacological effects
Prodrug
50
2 major types of prodrugs
Type I, Type II
51
Type of prodrug that turn into their active forms inside of cells
Type I prodrug
52
Type of prodrug that turn into their active forms outside of cells
Type II prodrug
53
Is defined by the FDA as an active ingredient that has never before been marketed in any form
New molecular entity (NME)
54
Indicated the number and relationship of the atoms in the molecule (Drug nomenclature)
Empirical formula
55
Name of the compound's every part of molecular structure (Drug nomenclature)
Chemical name
56
Non-proprietary name of the drug; refers to the active ingredient of the drug (Drug nomenclature)
Generic name
57
Trademarked name/Marketed name assigned by the producing company (Drug nomenclature)
Brand name
58
Treatment that are sought for to target small number of patients with rare conditions/diseases
Orphan drug
59
Rare disease/condition affecting fewer than 200,000 people
Orphan disease
60
5 examples of orphan disease
Chronic lymphocytes, Leukemia, Gaucher's disease, Cystic fibrosis, AIDS
61
Concerned with drugs, their sources, appearance, chemistry, action, and uses
Pharmacology
62
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
Pharmacodynamics
63
Is the science that analyzes how the human body interacts with a drug
Pharmacokinetics
64
The primary objective of __________ is to obtain basic information on the drugs' effects that maybe safe and effective use in humans
Animal studies
65
Done in dogs and rats (Animal studies)
Hypertensive studies
66
Done in dogs and guinea pigs (Animal studies)
Respiratory effects studies
67
Done in dogs (Animal studies)
Diuretic activities
68
Done in rabbits (Animal studies)
Blood coagulation
69
Done in mice and rabbits (Animal studies)
Central nervous system studies
70
Involves those chemical processes within living organisms to maintain life
Drug metabolism
71
Transit through the liver and exposure to the hepatic enzyme system
1st pass effect
72
Performed through the collection and analysis of urine, blood and feces samples, and careful exam
ADME studies
73
Deals with the adverse or undesired effects of drugs
Toxicology
74
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)
Acute/short term toxicity studies
75
Considered: the relationship to projected human clinical studies for safety (Different studies in toxicological profile)
Subacute/subchronic studies
76
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)
Chronic toxicity studies
77
Long term studies (18-24 months) with surviving animals killed and studied at defined weeks during the test period (Different studies in toxicological profile)
Carcinogenicity studies
78
Reveals any effect of an active ingredient on mammalian reproduction (Different studies in toxicological profile)
Reproduction studies
79
Determines whether test compound affects gene mutation or cause chromosome or DNA damage (Different studies in toxicological profile)
Genetoxicity/mutagenecity studies
80
Is a measure of its distribution in a lipophilic-hydrophilic phase system and indicates its ability to penetrate biological multiphase system
Partition coefficient
81
Speed/rate at which a drug substance dissolved in a medium
Dissolution rate
82
Part of the IND application; submitted to ensure the appropriate design and conduct of investigation
Clinical protocol
83
Stage where animal pharmacology and toxicology data are obtained (Phases of product development)
Preclinical stage
84
Stage which is the initial introduction and includes 20-100 healthy volunteers (Phases of product development)
Phase I
85
Stage where controlled clinical studies to several hundred patients with the disease/condition are treated (Phases of product development)
Phase II
86
Phase where several hundred to several thousand patients with the disease/condition treated for which the drug was developed (Phases of product development)
Phase III
87
Phase where completed studies are sufficient for the NDA (Phases of product development)
Phase 3a
88
Phase where additional studies are used to gather supplemental information to support certain labelling requests (Phases of product development)
Phase 3b
89
Phase which has continual clinical investigation and manufacturing scale-up activities (Phases of product development)
Phase IV
90
Phase where product development continues after the FDA's market approval of the product (Phases of product development)
Phase V (Post marketing surveillance)
91
Is required to report to the FDA each adverse drug experience that is both serious and unexpected
Drug sponsor
92
Letter for approval of the application permitting marketing
Approval letter
93
Letter for one or more deficiencies
Non-approvable letter
94
Derived from biological assay methods; reflects drug's potency
Units of activity
95
Determines minimum concentration expected to produce the drug's desired effects in a patient
Minimum effective concentration (MEC)
96
Above the average blood serum concentration level producing toxic effects
Minimum toxic concentration (MTC)
97
Produces the desired intensity of effect in 50% of the individuals tested
ED50/Median effective dose
98
Produces a defined toxic effect in 50% of the individuals tested
TD50/Median toxic dose
99
Ratio of drug's median toxic dose and median effective dose
Therapeutic index
100
Regularly schedule subsequent administration to keep the most desirable concentration of drug in the blood
Maintenance dosage
101
Required to attain desired concentration of the drug in the blood of tissues
Initial priming/loading dose
102
Protects the patient from contracting the illness
Prophylactic dose
103
Administered to the patient after exposure or contraction of the illness
Therapeutic dose
104
Effect of drug modified by prior/concurrent administration of another drug
Drug-drug interaction
105
3 general areas being focused on by the International Conference on Harmonization (ICH)
Quality, Safety, Efficacy
106
Stability, light stability, analytical validation, impurities and biotechnology (General areas of ICH)
Quality topics
107
Carcinogenicity, genotoxicity, toxicokinetics, reproduction toxicity, and single and repeat dose toxicity (General areas of ICH)
Safety topics
108
Population exposure, managing clinical trials, clinical study reports, dose response, ethnic factors, and good clinical practices and geriatrics (General areas of ICH)
Efficacy topics
109
Established by the Food and Drug Administration (FDA) to ensure the minimum standards are met for drug product quality
Current Good Manufacturing Practice (cGMP)
110
Holds the article and is or maybe in direct contact with the article
Container
111
Is a container that it is in direct contact with the article at all times
Immediate container
112
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
Well-closed container
113
Is a container that protects the contents from the contamination by extraneous liquids, solids, or vapors
Tight container
114
Is a container that is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution
Hermetic container
115
Is a container that holds a quantity of drug intended as a single dose
Single-dose container
116
Is a container that permits withdrawal of successive portions of the contents
Multiple-dose container
117
Is a container designed to hold a quantity of drug intended for administration as a single dose promptly after the container is opened
Single-unit container
118
A single-unit package is termed a __________
Unit dose package
119
Is a container that contain more than a single unit or dose of the medication
Multiple-unit container
120
Highly resistant borosilicate glass (Official glass types)
Type I
121
Treated soda lime glass (Official glass types)
Type II
122
Soda lime glass (Official glass types)
Type III
123
General purpose soda lime glass (Official glass types)
Type NP
124
3 examples of plastic materials
PET, APET, PETG
125
Meaning of PET
Polyethylene terephthalate
126
Meaning of APET
Amorphous polyethylene terephthalate glycol
127
Meaning of PETG
Polyethylene terephthalate glycol
128
2 plastic materials that has excellent transparency and luster and can be sterilized with gamma radiation
APET, PETG
129
A term used to describe the movement of components of a container into the contents
Leaching
130
A term used to indicate the binding of molecules to polymer materials, which includes both absorption and adsorption
Sorption
131
Not exceeding 8°C (Storage description)
Cold
132
Temperature range of refrigerator
2 to 8°C
133
Temperature range of freezer
-25 to -10°C
134
Between 8°C and 15°C (Storage description)
Cool
135
Between 20°C and 25°C (Storage description)
Room temperature
136
Between 30°C and 40°C (Storage description)
Warm
137
Above 40°C (Storage description)
Excessive heat
