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PDDS > TOPIC 2 > Flashcards

TOPIC 2 Flashcards

1
Q

MOLECULAR DISCOVERY &
CHARACTERIZATION

A
  1. GOAL DRUG
  2. PRODRUG
  3. BIOASSSAY
  4. LEAD COMPOUND
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2
Q

identified during drug
discovery and
development

It serves as the
starting point.

chosen based on their
ability to interact with
a specific target

A

Lead Compound

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3
Q

the ultimate
objective in drug
development,
which is to create a
safe and effective
medication

A

Goal Drug

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4
Q

an inactive or less
active precursor
molecule of a drug
that undergoes a
chemical or
enzymatic
transformation
within the body to
become an active
therapeutic agent

A

Prodrug

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5
Q

A compound that requires
metabolic biotransformation
after administration to
produce the desired pharmacologically active compound

A

Prodrugs

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6
Q

Aspirin is a prodrug of?

A

Salicylic acid

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7
Q

Enalapril ->

A

enalaprilat

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8
Q

Epinephrine ->

A

Dipivefrin

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9
Q

Epinephrine -> Dipivefrin:

A

◦ Enhanced solubility
◦ Enhanced lipophilic character
◦ Enhanced duration of action

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10
Q

Reserpine

A

▫ Rauwolfia serpentina
▫ (reserpine) tranquilizer and hypotensive
agent

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11
Q

Periwinkle

A

▫ Vinca rosea
▫ Vinblastin and Vincristine
▫ For cancer

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12
Q

Pacific Yew Tree

A

Taxus brevifolia

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13
Q

Animal Source

A

Endocrine glands of cattle, sheep and swine
Pregnant mares.
Embryo

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14
Q

Endocrine glands of cattle, sheep and swine

A

Thyroid extract, insulin and pituitary hormone
(replacement therapy)

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15
Q

Pregnant mares

A

Source of estrogens

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16
Q

Embryo

A

vaccines

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17
Q

Microbiological Source

A

penicillin, cephalosphorin,
tetracyclines,
aminoglycosides, lovastatin

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18
Q

Genetic engineering

A

Recombinant DNA

Monoclonal Antibody production

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19
Q

PRE- CLINICAL TRIAL:

A

●Chemical and physical characterization
●Pharmacology
●Pharmacokinetics
●Pharmacodynamics
●Analytical studies
●Toxicology
●Pharmaceutics
●File IND Application

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20
Q

Once passed
with pre clinical
submit

A

INVESTIGATIONAL
NEW DRUG (IND)

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21
Q

the science of the properties of the drugs
and its effects in the body

A

Pharmacology

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22
Q

the study of the interaction of drugs
with cells

A

Pharmacodynamics

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23
Q

the handling of a drug within the
body, it includes the ADME processes

A

Pharmacokinetics

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24
Q

are observational studies that are aimed
at objective examination and assessment − analysis − of
causal relationships between exposure to potential disease
determinants (risk factors) and subsequent disease

A

Analytical studies

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25
Q

the study of the A/E of the chemical agents on living
organisms

A

Toxicology

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26
Q

the general area of study concerned with the
formulation, manufacturing stability and effectiveness of a
pharmaceutical dosage form

A

Pharmaceutics

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27
Q

an exclusive rights to the use and profits of a novel
pharmaceutical for a limited term

A

Patent the drug

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28
Q

PRE- CLINICAL TRIAL Special consideration is given on

A

Orphan drugs and
Treatment IND, Emergency IND

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29
Q

Physical – Chemical
Characterization:

A
  • Solubility
  • Partition coefficient
  • Dissolution rate
  • Physical form
  • Stability
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30
Q

preclinical data to check whether the product is safe for initial testing in humans

A

Animal Pharmacology and Toxicology Studies

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31
Q

information about composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product

A

manufacturing information

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32
Q

detailed plan for proposed clinical studies to assess whether the initial phase trials will expose subjects to unnecessary risks

A

clinical protocols and investigator information

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33
Q

schedule of dosage

A

Dosage Regimen

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34
Q

the amount that may be expected to
produce, in adults, the medicinal effect for which it is
intended

A

Usual dose

35
Q

amounts of drug that may be
prescribed within the work of usual medical practice

A

Usual dosage range

36
Q

dose administered to children

A

Pediatric dose

37
Q

also the priming or loading dose, is the
amount required to attain the desired concentration
of the drug in the blood or tissues

A

Initial dose

38
Q

the amount administered to a patient before
exposure or contraction of the illness

A

Prophylactic dose

39
Q

the amount which is administered to a patient
after the exposure or contraction of an illness

A

Therapeutic dose

40
Q

The relationship between the desired and undesired effects of
a drug

A

Therapeutic Index

41
Q

Therapeutic Index:

A

TD50/ ED50

42
Q

Factors Affecting the Dose

A

Age
Pharmacogenetics– genetic polymorphism
Body Weight
Body Surface Area - nomogram
Sex
Pathologic State
Tolerance
Concomitant Drug therapy
Time and conditions of administration
Dosage Form and Route of Administration

43
Q

Phase I:

A

Tolerance and safety
20 – 100 healthy volunteer
Toxicological studies

44
Q

Phase II

A

100 – 300 first controlled studies
on patients
Efficacy and therapeutic index

45
Q

Phase III

A

1000 – 3000 extended clinical trials
dose, efficacy, toxicity and
side effects
Performed with the final dosage form
developed in phase II
Side effects are monitored

46
Q

Phase IV

A

Post marketing studies
Drug product may be improved
Modification on drug formulation as
obtained from manufacturing scale
up
and validation process may be done
Additional clinical studies

47
Q

NDA is submitted to the FDA for _____
showing product is effective by all parameters

A

review and approval

48
Q

The data gathered during the animal studies and human clinical
trials of an ______ become part of the NDA.

A

Investigational New Drug (IND)

49
Q

increase in the batch size from
the clinical batch, submission batch, or to
the full-scale production batch size, using
the finished, marketed product.

A

Scaleup

50
Q

USP–NF <795>

A

Pharmaceutical Compounding- Nonsterile
Preparations

51
Q

USP–NF <797>

A

Pharmaceutical Compounding- Sterile
Preparations

52
Q

USP–NF <1160>

A

Pharmaceutical Calculations in Prescription
Compounding

53
Q

USP-NF <1163>

A

Quality Assurance in Pharmaceutical
Compounding

54
Q

USP-NF <1176>

A

Prescription Balances and Volumetric
Apparatus

55
Q

USP-NF <85>

A

Bacterial Endotoxins Test

56
Q

USP-NF <1151>

A

Pharmaceutical dosage form

57
Q

USP-NF <795>

A

Pharmacy Compounding- Nonsterile
Preparations

58
Q

USP-NF <797>

A

Pharmacy Compounding- Sterile Preparations

59
Q

USP-NF <800>

A

Hazardous Drugs

60
Q

is “that which holds the
article and is or may be in direct
contact with the article.”

A

Container

61
Q

is “that which is in direct contact
with the article at all times. The
closure is part of the container.

A

Immediate container

62
Q

It 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

63
Q

protects the contents from contamination by extraneous liquids,
solids, or vapors; from loss of the article; and from
efflorescence, deliquescence, or evaporation
under the ordinary or customary conditions of handling, shipment,
storage, and distribution and is capable of tight reclosure

A

Tight container

64
Q

impervious to air
or any other gas under
the ordinary or
customary conditions of
handling, shipment,
storage, and
distribution.”

A

Hermetic container
and Sterile hermetic

65
Q

Other containers:

A

Multiple-unit containers and
Multiple-dose container
Single dose container Single-unit
package

66
Q

Plastic containers advantages

A

Lightness of weight
Versatility
Convenience
For unit
dose delivery

67
Q

movement of the
product components outward
toward the container

A

Permeability

68
Q

movement of the
components of the container into
the contents

A

Leaching

69
Q

binding of molecules to
polymer materials

A

Sorption

70
Q

deformation which may be
softening, hardening and other
physical changes in the plastic
container

A

Alteration of container

71
Q

A test used to determine resistance to water
attack
Amount of alkali that release into the the content

A

LEACHING

72
Q

is used to
reduce the risk of poisoning in children via
the ingestion of potentially hazardous
items including certain prescription and
over-the-counter (OTC) medications,
pesticides, and household chemicals.

A

Child-resistant (C-R) packaging

73
Q

one that is significantly difficult to open
by children 5 years under

A

Child-resistant (C-R) packaging

74
Q

Child-resistant (C-R) packaging 4 Basic
designs:

A
  1. align the arrows
  2. press down and turn
  3. squeeze and turn
  4. latch top
75
Q

Cold:

A

between 2°C and 8°C
**not more than 8°C

76
Q

freezer

A

− 25°C and − 10°C ( ** some below 20c)

77
Q

Cool:

A

8°C and 15°C

78
Q

Room temperature:

A

Ambiance temperature” Temperature prevailing in a
working area.

79
Q

Controlled room
temperature

A

20°C to 25°C but also allows for temperature variations
between 15°C and 30°C
The mean kinetic temp (MKT) should not exceed 25c

80
Q

Warm:

A

30°C and 40°C

81
Q

Excessive heat:

A

Above 40°C

82
Q

Protection from light

A

Light-resistant container

83
Q

Protection for freezing

A

Protect the product from Freezing

PDDS (6 decks)

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