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DDS > Drug Development > Flashcards

Drug Development Flashcards

1
Q

An agent used in the diagnosis, mitigation,
treatment, cure, or prevention of diseases in
humans and animals.

A

Drug

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2
Q

Greek physician who is
credited with the
introduction of scientific
pharmacy and medicine.

A

Hippocrates

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3
Q

Hippocrates is known as the ______

A

Father of Medicine

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4
Q

Established the Theory of Humoral Pathology

A

Hippocrates

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5
Q

Greek physician, botanist, and Pharmacologist who dealt with botany as an applied science of Pharmacy

A

Pedanius Dioscorides

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6
Q

Work of Pedanius Dioscorides which served as a milestone in the development of pharmaceutical botany and pharmacognosy.

A

De Materia Medica

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7
Q

Swiss physician and chemist who
introduced chemical science from the
traditional botanical science.

A

Aureolus Philipus Theophrastus Bombastus von Hohenheim (Paracelsus)

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8
Q

A Swedish Pharmacist who discovered Oxygen a year before

Priestley.

A

Karl Wilhelm Scheele

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9
Q

German pharmacist who isolated morphine

from opium.

A

Friedrich Serturner

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10
Q

He independently isolated codeine from opium

A

Pierre Robiquet

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11
Q

They isolated quinine and cinchonine from

cinchona.

A

Joseph Caventou and Joseph Pelletier

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12
Q

Discovered strychnine and

brucine from Nux vomica.

A

Joseph Caventou and Joseph Pelletier

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13
Q

Isolated caffeine

A

Pierre Robiquet and Joseph Pelletier

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14
Q

The scientific basis for drug products
to ensure uniformity and quality
leading to the development and
publication of monographs.

A

Drug Standards

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15
Q

The term pharmacopoeia comes from the
Greek word “_______” (drug) and
“_______” (to make).

A

Pharmakon

Poiein

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16
Q

Present official standard of Purity, Strength,

Quality, and Analysis of drugs

A

Pharmacopeia

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17
Q

Contains drug
monographs which assured availability
of quality drugs and pharmaceutical
products.

A

Official Compendia

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18
Q

The first American pharmacopeia published

in 1778 at Lititz, Pennsylvania.

A

Lititz Pharmacopeia

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19
Q

Lititz Pharmacopeia was a 32-page booklet consisting of __
internal and __ external drugs and
preparations.

A

84 internal and 16 external drugs

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20
Q

The Father of USP

A

Dr. Lyman Spalding

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21
Q

When was the first USP published in English and Latin

A

December 15, 1820

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22
Q

The first USP was a 272-

page and ___ drugs were listed in it.

A

217 drugs

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23
Q

T/F : At first, the revision of USP was every 10
years but was decided to revise it every 5
years (1940).

A

True

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24
Q

In 1888, the first National Formulary was

published under the title ____________

A

“National

Formulary of Unofficial Drugs”.

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25
Q

T/F: In 1975, US pharmacopoeial convention purchased NF.

A

True

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26
Q

T/F: In 1980, the first combined compendium

(USP-NF) was published.

A

True

27
Q

T/F: In 1864, the first English

Pharmacopoeia was published

A

False. In 1864, the first British Pharmacopoeia was published.

28
Q

Contents of the Monograph

A
  1. Official Title (Generic Name)
  2. Graphic or Structural Formula
  3. Empirical Formula
  4. Molecular Weight
  5. Established Chemical Names
  6. Chemical Abstracts Service (CAS) Registry
    Number
  7. Chemical Purity- In terms of percentage
  8. Cautionary Statement
  9. Packaging
  10. Storage
  11. Chemical and Physical Tests
  12. Method of Assay
29
Q

Other References to Drug Standards:

A

• Homeopathic Pharmacopoeia of the United
States (HPUS)
• International Pharmacopoeia/
Pharmacopeia Internationalis (Published by
WHO)
• BP
• EP

30
Q

Sources of New Drugs

A
  • Plant Kingdom
  • Animal sources
  • Microbiological world
  • Biological Source
31
Q

An animal source developed from vampire bat
saliva to treat heart attacks and strokes in
humans

A

Draculin

32
Q

For thyroid extract, insulin and pituitary hormone (Replacement Therapy).

A

Endocrine glands of cattle, sheep, and swine

33
Q

Source of Estrogen

A

Urine of pregnant mares

34
Q

Serums, Anti-toxins, and Vaccines

A

Biological Sources

35
Q

Who discovered the smallpox vaccine in England in 1976?

A

Edward Jenner

36
Q

Characteristics of Goal Drug

A

• Produces the specifically the desired effect
• Administered by the most desired route(Generally orally)
• Minimal dosage and dosage frequency
• Has optimal onset and duration of activity
• Easily produced at low cost
• Pharmaceutically elegant
• Physically and chemically stable in various
conditions of use and storage
• Exhibit no side effect
• Would be eliminated completely and
without residual effect

37
Q

Drug Discovery

A 
• Choosing a Disease – Focus is on the financial
return
• Choosing a drug Target – Receptor, enzymes, and
metabolic processes.
• Medical Folklore
• Existing Drugs
• Combinatorial Synthesis
• Molecular Modification
• Mechanism-based Design
• Computer-aided Design
• Serendipity and Prepared Mind
• Use of NMR
38
Q

Initial bioassay that takes
place outside the organism, in an artificial
environment such as a laboratory where
drug activity is tested on isolated tissues,
cells, or enzymes.

A

In Vitro Test

39
Q

Subsequent bioassay by
biological experiment or technique carried
out within a living organism

A

In Vivo Test

40
Q

20 to 80 healthy volunteers

A

Phase 1

41
Q

100 to 300 patient volunteers

A

Phase 2

42
Q

1000 to 3000 patient volunteers

A

Phase 3

43
Q

Laboratory and animal studies

A

Pre-clinical testing

44
Q

The phase which determines safety and

dosage, and Bioavailability of the drug

A

Phase 1

45
Q

Evaluate
effectiveness,
look for side
effects

A

Phase 2

46
Q

Verify effectiveness,
monitor adverse
reactions from longterm
use

A

Phase 3

47
Q

Assess
safety and
biological
activity

A

Pre-clinical testing

48
Q

Pre-clinical studies

A
  • Chemical and Physical Characterization
  • Pharmacology
  • Pharmacokinetics
  • Pharmacodynamics
  • Pharmaceutics
  • Analytical studies
  • Toxicology
49
Q

T/F: In Double Blind Studies, the patient does not
know or unaware of the agent administered while in Single Blind Studies, neither the patient
nor the clinician is aware of the agent
administered.

A

False.

• Single Blind Studies - The patient does not
know or unaware of the agent administered.

• Double Blind Studies - Neither the patient
nor the clinician is aware of the agent
administered.

50
Q

Parties are aware of
the agents’ identities that will be
administered to them.

A

Open Label Studies

51
Q

T/F: NDA is submitted to the FDA for review and
approval after the completion of the clinical
trials and requirements have been met.

A

True

52
Q

The Post Marketing Studies and manufacturing scale-up

activities take place.

A

Phase IV

53
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

Scale Up

54
Q

T/F: In Phase 4, product development can not be continued.

A

False. Product development may continue.

55
Q

Filed for generic copies by competing
companies following expiration of patent
term protection.

A

ANDA or Abbreviated New Drug Application

56
Q

There are changes in
synthesis, formulation, analytical standards,
containers, and labeling of drug products.

A

SNDA or Supplemental New Drug Application

57
Q

A prototype chemical compound that has a

fundamental desired biologic or pharmacologic activity.

A

Lead Compound

58
Q

T/F: Since most drugs have primary and secondary effects, taking advantage of
secondary effects leads to a drugs secondary indication.

A

True

59
Q

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

A

Prodrugs

60
Q

A combination of two or more old drugs or
change in usual proportions of drugs in an
established combination product is
considered new if the change alter safety
and efficacy.

A

New Drug

61
Q

A drug is not considered a New Drug when there is only a change is previously approved
formulation or method of manufacture
constitutes newness since such change can
alter effects and safety of a product.

A

False.

62
Q

A drug is not considered a New Drug when there is only a change is previously approved
formulation or method of manufacture
constitutes newness since such change can
alter effects and safety of a product.

A

False. New Drug is a change is previously approved
formulation or method of manufacture
constitutes newness since such change can
alter effects and safety of a product.

63
Q 
A proposed new use for an established drug,
a new dosage regimen or schedule, a new
route of administration, or a new dosage
form leads to a drug’s status new and
triggers reconsideration for safety and
efficacy.
A

New Drug

DDS (18 decks)

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