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PH107:Pharmaceutical Dosage Form, Drug Delivery System & Medical Devices > Drug Development Process > Flashcards

Drug Development Process Flashcards

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USMLE® Step 1 flashcards
1
Q

When the nucleus of the drug from natural source as well as its
chemical structure is altered.
 Examples
Emetine Bismuth Iodide

A

Synthethic

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2
Q

When the nucleus of drug obtained from natural source is
retained but the chemical structure is altered.
Examples Apomorphine, Diacetyl morphine, Ethinyl
Estradiol, Homatropine, Ampicillin and Methyl testosterone.

A

Semi synthetic

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3
Q

Most of the drugs used nowadays such as antianxiety drugs,
anti convulsants are?

A

Synthethic

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4
Q

GENETIC ENGINEERING

A

-Recombinant DNA & monoclonal antibody
-GENE THERAPY

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5
Q

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

A

GENE THERAPY

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6
Q

technology 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

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7
Q

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

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8
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

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9
Q

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

A

lead compounds

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10
Q

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

A

Drug design strategies

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11
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

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12
Q

Rare disease/condition affecting fewer than 200,000
people:
*chronic lymphocytes *leukemia
*Gaucher’s disease *cystic fibrosis AIDS

A

ORPHAN DISEASE

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13
Q

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

A

broken down

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14
Q

a chemical that is transformed before it has
pharmacological effects.

A

PRODRUG

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15
Q

it may prevent a prodrug from becoming
active.

A

certain interactions

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16
Q
A
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17
Q

drug is inactive before metabolism and drug becomes active after metabolism

A

Prodrug

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18
Q

drugs takes effect directly

A

Active drug

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19
Q

two major types of prodrugs

A

Type I
Type II

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20
Q

prodrugs turn into their active forms inside of cells.

A

Type I

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21
Q

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

A

Type II

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22
Q

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

A

New Molecular Entity (NME)

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23
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 DRUG

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24
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 DRUG

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25
Q

indicates the number and relationship pf
the atoms in the molecule
Example:
Amoxicillin- C16H19N3O3S.3H2O

A

Empirical formula

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26
Q

name of the compound’s every part of
molecular structure
Example: Amoxicillin- (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

chemical name

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27
Q
A
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28
Q
A
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28
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.
 Example: Amoxicillin

A

Generic name

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29
Q
A
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30
Q

trademarked name/ marketed name assigned
by the producing company
Example:
HimoxTM
AmoxilTM
TrimoxTM

A

Brand name

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31
Q

must undergo preclinical testing
for biologic activity to assess their potential as useful
therapeutic agents.
 Pharmacology
 Drug Metabolism
 Toxicology

A

Prospective drug substances

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32
Q

To evaluate whether a drug is safe and effective, information
must be gained on how it is absorbed, distributed throughout
the body, stored, metabolized, and excreted and how it
affects the action of the body’s cells, tissues, and organs.

A

BIOLOGICAL CHARACTERIZATION

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33
Q

The science concerned with drugs, their sources, appearance,
chemistry, actions and uses. It includes the biochemical and
physiologic effects, mechanism of action, absorption,
distribution, biotransformation, and excretion.

A

Pharmacology

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34
Q

is the science that analyzes how the human
body interacts with a drug.

A

Pharmacokinetics

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35
Q

examines how
the drug is absorbed, distributed, metabolized, and excreted
by the body.

A

Pharmacokinetics

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36
Q

is the 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

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37
Q

what the body does to the
drug

A

pharmakokinetics

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38
Q
A
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39
Q

what the drug does to
the body

A

pharmacodynamics

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40
Q

drug administration
drug absorption
drug distribution
drug metabolism
drug elimination

A

Pharmacokinetics

41
Q

receptor enzyme ion channel transporter
regulatory proteins
binds to molecular target- affinity
mechanism of drug action
response to drug -efficacy

A

pharmacodynamics

42
Q
A
43
Q

to obtain
basic information on the drugs effects that maybe safe
and effective use in humans.

A

Animal studies

44
Q

Hypertensive studies-

A

Dogs & rats

45
Q

Respiratory effects studies

A

dogs and guinea pigs

46
Q

Diuretic activities

A

Dogs

47
Q

blood coagulation

A

rabbits

48
Q

central nervous system studies

A

mice and rats

49
Q

involves those chemical process
within living organism to maintain life.

A

Drug Metabolism

50
Q

Series of animal studies of a proposed drugs ADME are
undertaken to determine the following:

A

-Extent and rate of drug absorption from various route of
administration
-Rate of distribution of the drug through the body and the
site and duration of drug’s residence
-Rate, primary and secondary sites, mechanism of the
drug’s metabolism in the body
-Proportion of administered dose eliminated from the
body

51
Q

Participate in drug metabolism (liver, kidneys, lung & git)

A

Specific & non-specific enzymes

52
Q

exposed to rapid
drug metabolism

A

Drugs following oral adm. that enter the hepatic
circulation after absorption from gut

53
Q

transit through the liver & exposure to the
hepatic enzyme system

A

1st pass effect

54
Q

performed through the collection &
analysis of urine, blood & feces samples, & careful exam.
Of animal tissues & organs upon autopsy

A

ADME studies

55
Q

Deals with the adverse or undesired effects of
drugs

A

TOXICOLOGY

56
Q
  • toxic effect of a test compound when administered in single
    dose and/or multiple doses over short period, usually a single
    day.
A

Acute or short-term toxicity studies

57
Q

Animal toxicity studies (minimum of two weeks of daily
drug administration at 3 or more dosage levels to two
animal species) are required to support the initial
administration of a single dose in human clinical testing

A

Subacute or subchronic studies

58
Q

animal studies of 90 to 180 days

A

Chronic toxicity studies

59
Q

For chronic human illness, long-term animal studies of

A

1
year or longer

60
Q

For limited no. of rat and mouse strains
Long term studies (18-24 months) with surviving animals killed
& studied at defined weeks during the test period

A

Carcinogenicity studies

61
Q

reveals any effect of an active ingredient on mammalian
reproduction

A

Reproduction Studies

62
Q

Determines whether test compd affects gene mutation or
cause chromosome or DNA damage

A

Genotoxicity or Mutagenicity Studies

63
Q

Used in assays to detect mutations:

A

Strains of Salmonella
typhimurium

63
Q

Each drug substance has intrinsic chemical and
physical characteristics that must be considered
before the development of a pharmaceutical
formulation

A

 DRUG SOLUBILITY
 PARTITION COEFFICIENT
 DISSOLUTION RATE
 PHYSICAL FORM
 STABILITY

64
Q

administered by any route
must possess some aqueous solubility for
systemic absorption and therapeutic response

A

DRUG SOLUBILITY

65
Q

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

A

PARTITION COEFFICIENT

66
Q

It is the speed at which a drug substance dissolves
in a medium

A

DISSOLUTION RATE

67
Q

The crystal or amorphous forms and/ or the
particle size of a powdered drug can affect the
dissolution rate, thus the rate and extent of
absorption, for a number of drugs

A

Physical forms

68
Q

testing at various temperature,
conditions of relative humidity (RH), durations, and
environments of light, air and packaging is
essential in assessing drug

A

Stability

69
Q

To protect the rights and safety of the subjects
and to ensure that the investigational plan is
sound and is designed to achieve the stated
objectives

A

Investigational New drug
(IND)

70
Q

part of the IND application
 submitted to ensure the appropriate design and conduct
of investigation
 Includes:
*purpose & objectives *investigational plan
*number of patients *subject selection
*dosing plan
*clin. procedures, lab. tests
*patient observations, measurements & tests, etc.

A

The clinical protoco;

71
Q

FDA classifies the drug by:

A

*chemical type
*therapeutic potential

72
Q

Animal pharmacology & toxicology data are obtained
- determines the safety & efficacy of the drug
- submission of investigational new drug (IND) application
for human testing to the FDA

A

Pre clinical

73
Q
  • initial introduction (Clinical testing)
  • subjects: Healthy volunteers (20-100)
  • determines drug tolerance & toxicity (assessing safety)
A

Phase 1

74
Q

Controlled clinical studies to several hundred
patients with the disease/condition are treated
- Safety measured - determines the therapeutic
index (ratio of toxic dose to effective dose)
 final drug formulation developed bioequivalent
(same rate & extent of drug absorption to the brand
drug product) to the dosage form

A

Phase II

75
Q

several hundred to several thousand patients with
the disease/condition treated for which the drug
was developed (controlled and uncontrolled trials)
- Large scale, multicenter studies performed - to
determine safety & and efficacy
-Side effects are monitored

A

Phase III

76
Q

Phases of Clinical Investigation

A

Phase 3a
Phase 3b
Submission of a new drug application (NDA)
Phase IV
Phase V (POST MARKETING SURVEILLANCE)

77
Q
  • completed studies sufficient for the NDA
A

Phase 3a

78
Q

Additional studies are used to gather:
*supplemental information to support certain labeling
requests
* information on patients’ quality of life issues
*product advantages over already marketed competing
drugs
*evidence in support of possible additional drug
indications
*other clues for prospective postmarketing studies

A

Phase 3b

79
Q

An NDA is submitted to the FDA for review &
approval when clinical trials are completed

A

Submission of a new drug application (NDA)

80
Q
  • Continual clinical investigation
  • Manufacturing scale-up activities
  • Drug formulation modified slightly
  • To gather supplemental information (labeling,
    product advantages, additional indications,
    prospective postmarketing studies)
A

Phase IV

81
Q

 Product development continues after the FDA’s market
approval of drug product.
 Drug product may be improved due to equipment,
regulatory, supply or market demands

A

Phase V (POST MARKETING SURVEILLANCE)

82
Q

Phases of Clinical Testing:

A

PRECLINICAL M
PHASE I-Drug approved for testing in humans
PHASE II
PHASE 3
FDA Review
PHASE 4- drug approved

83
Q

STAGES OF DRUG DEVELOPMENT PROCESS

A

Discovery stage
Development stage

84
Q

Discovery stage

A

identify target
identify compounds
establish activity
select clinical candidates

85
Q

Development stage

A

Test for safety
Human Clinical Trial Phase I
Human Clinical Trial Phase II
Human Clinical Trial Phase III
Human clinical trial phase IV

86
Q

Factors in determining drug’s dose

A

 Age
 Body weight
 Sex
 Body surface are
 tolerance
 General health status
 Pathologic condition(s)
 Concomitant drug therapy
 Dosage form, time & route of administration

87
Q

amount of drug that produces the desired effect in
the majority of adult patient

A

usual adult dose & starting dose for the patient

88
Q

determined
from:
* clinical investigation
* inherent duration of action
* pharmacokinetics
* characteristics of the dosage form.

A

Dosage regimen/schedule of dosage

89
Q

drug’s Average blood serum concentration
- Determines minimum concentration expected to
produce the drug’s desired effects in a patient

A

Minimum effective concentration (MEC)

90
Q

Second level of serum concentration of drug
- Above the average blood serum concentration level
producing toxic effects
- Negates desirable effects of the drug compromising
safety of the patient

A

Minimum toxic concentration (MTC)

91
Q

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

A

ED50/Median Effective Dose

92
Q

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

A

Median toxic dose

93
Q

Relationship between drug’s desired & undesired
effects
- Ratio of drug’s median toxic dose & median
effective dose, TD50/EF50

A

Therapeutic index

94
Q

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

A

Maintenance dosage

95
Q

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

A

Initial priming or loading dose

96
Q

protects the patient from
contracting the illness

A

Prophylactic dose

97
Q

administered to the patient
after exposure or contraction of the illness.

A

Therapeutic dose

98
Q
  • Effect of drug modified by prior/concurrent
    administration of another drug
  • Chemical or physical interaction between the
    drugs/alteration of the absorption, distribution,
    metabolism/excretion patterns of one of the drugs
  • Include “social” agents (tobacco & alcohol) affecting
    pharmacokinetics of a number of drugs & alter drug’s
    usual dose
A

Drug-drug interaction

PH107:Pharmaceutical Dosage Form, Drug Delivery System & Medical Devices (13 decks)

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