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DDS > new drug development and approval process > Flashcards

new drug development and approval process Flashcards

1
Q

what are the sources of drugs

A

Natural sources
synthesized in laboratory
processes of biotechnology

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2
Q

certain major contributions to modern drug therapy may be attributed to the

A

successful conversion of botanic folklore remedies into modern wonder drugs

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3
Q

tranquilizer, hypotensive agent

A

reserpine/rauwolfia serpentina

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4
Q

diabetes mellitus

A

periwinkle or vinca rosea

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5
Q

plants extracts of V. rosea yield 2 potent drugs for certain types of cancer (leukemia, hodgkin disease)

A

vinblastine
vincristine

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6
Q

ovarian cancer

A

pacific yew tree

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7
Q

mumps and influenza vaccines

A

fluid of chick embryo

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7
Q

rich source of estrogen

A

urine of pregnant mares

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7
Q

poliomyelitis vaccines

A

renal monkey tissue

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8
Q

rubella (german measles)

A

duck embryo

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9
Q

new vaccines for diseases aids and cancer

A

cell and tissue cultures

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9
Q

smallpox vaccines

A

skin of bovine calves inoculated with vaccinia virus

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10
Q

requires metabolic biotransformation after administration

A

prodrug

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11
Q

science concerned with drugs, their sources, appearance, chemistry, actions and uses.

A

pharmacology

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12
Q

this extent and rate of drug absorption from various routes of administration

A

absorption

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13
Q

the rate of drug distribution of the drug through the body and the site or sites

A

distribution

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14
Q

the rate, primary and secondary sites, the mechanism of the drug’s metabolism

A

metabolism

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15
Q

the proportion of administered dose eliminated from the body

A

excretion/elimination

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16
Q

drug substance administered by any route

A

drug’s solubility

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17
Q

a measure of its distribution in a lipophilic - hydrophilic phase system

A

partition coefficient

18
Q

speed at which drug substance dissolves in a medium is called

A

dissolution rate

19
Q

reducing the particle size and increasing the powder fineness

A

physical form

20
Q

the chemical and stability of drug substance are critical to prepare a successful pharmaceutical product

A

stability

21
Q

pre-formulation studies

A

drug’s solubility
partition coefficient
dissolution rate
physical form
stability

22
Q
  • healthy volunteers
  • 20 to 100 subjects
  • initial dose of drug is low
  • greater dose until some evidences of the drug’s effect
  • determine the human pharmacology
A

phase 1

23
Q
  • evaluate the effectiveness of a drug in patients with the condition.
  • uses patients as subjects
  • determine the pharmacokinetics of the drug
A

phase 2

24
Q
  • several hundred to several thousand patients in controlled and uncontrolled trials
  • determine the usefulness of the drug
A

phase 3 and phase 4

25
Q

a standard or comparator drug product

A

placebo drug

26
Q

the patient is unaware of the agent administered

A

single blind studies

27
Q

neither the patient nor the clinician is aware of the agent administered

A

double blind studies

28
Q

neontal, pediatric, and geriatric patients

A

age

29
Q

doses for certain drugs are based on ______

A

body weight

30
Q

other important studies on women

A

sex

31
Q

ability to endure the influence of drug

A

tolerance

32
Q

effects of a drug may be modified by the prior

A

concomitant drug therapy

33
Q

oral therapy in relation to meals

A

time

34
Q

drugs administered intravenously enter the bloodstream

A

dosage form and route of administration

35
Q

including the proprietary and nonproprietary names

A

description of the product

36
Q

including a summary of actions of the drug in humans

A

clinical pharmacology

37
Q

including the FDA-approved indications in the treatment

A

indications and usage

38
Q

situations in which the drug should not be used

A

contraindications

39
Q

including descriptions of serious adverse reactions and potential safety

A

warnings

40
Q

including special care to be exercised by prescriber and patient in the use of the drug

A

precautions

41
Q

including predictable and potential unpredictable undesired side effects

A

adverse reactions

42
Q

including legal schedule if a controlled substance

A

drug abuse and dependence

43
Q

including signs, symptoms and laboratory findings of acute overdosage

A

overdosage

44
Q

stating the recommended usual dose

A

dosage and administration

45
Q

drug product labeling

A

adverse reactions
clinical pharmacology
contraindications
description of the product
dosage and administration
drug abuse and dependence
indications and usage
precautions
warnings
overdosage
precautions

46
Q
A

DDS (11 decks)

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