28-48 Flashcards

1
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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2
Q

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

A

Pharmacokinetics

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3
Q

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

A

Pharmacokinetics

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4
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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5
Q

“what the body does to the
drug,”

A

Pharmacokinetics

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6
Q

“what the drug does to
the body.”

A

Pharmacodynamics

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7
Q

are used to evaluate the pharmacologic effects of the agent on
specific organ system.

A

Whole animal studies

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8
Q

define further the
compound’s activity and selectivity.

A

Studies with isolated animal tissues

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9
Q

are then performed to detect evidence of efficacy and to determine
whether the compound is an agonist or antagonist.

A

Compounds effect on the cell function

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10
Q

for various receptors and its activity against select enzyme
systems.

A

Compound’s selectivity

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11
Q

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

A

Animal Studies

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12
Q

Hypertensive studies-

A

Dogs and rats

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13
Q

Respiratory effects studies-

A

Dogs and Guinea pigs

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14
Q

Diuretic activities-

A

Dogs

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15
Q

Blood coagulation

A

Rabbits

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16
Q

Central Nervous system studies-

A

Mice and rats

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17
Q

involves those chemical process
within living organism to maintain life.

A

Drug metabolism

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18
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

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19
Q

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

A

Specific & non-specific enzymes

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20
Q

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

A

Exposed to rapid drug metabolism

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21
Q

transit through the liver & exposure to the
hepatic enzyme system

A

1st pass effect

22
Q

what route of adm is used for the systemic cirulation through blood bessels other than hepatic

A

Adm of buccal and rectal

23
Q

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

A

ADME studies

24
Q

Deals with the adverse or undesired effects of drugs

A

Toxicology

25
Q

Preclinical safety evaluation or toxicity studies

A

toxicology

26
Q

enumerate what to determine in toxicology

A

 Substance’s potential for toxicity with short-term or long-
term use
 Substance’s potential for specific organ toxicity
 Mode, site and degree of toxicity
 Dose-response relationships over time
 Gender, Reproductive or teratogenic toxicities
 Substance’s carcinogenic and genotoxic potential

27
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

28
Q

find doses that do not to produce toxic
effect, severe toxic effect & intermediate toxic level

A

doses are ranged

29
Q

The relationship to projected human clinical studies
for safety

A

Subacute or subchronic studies

30
Q

how much is the minimum of drug administration of aniaml toxicity studies and dosage level

A

two weeks daily and 3 or more dosage levels

31
Q

drugs intended to be given to humans for a week or more, animal studies of 90 to 180 days in length must demonstrate safety

A

Chronic toxicity studies

32
Q

How long is the animal studies for chronic human illness

A

1 year or longer

33
Q

For limited no. of rat & mouse strains

A

Carcinogenicity studies

34
Q

with surviving animals killed
& studied at defined weeks during the test period

A

Long term studies

35
Q

how long does long term studies last?

A

18-24 months

36
Q

undertaken when the
compound has shown sufficient promise as a drug to enter
human clinical trials.

A

Component of chronic testing

37
Q

reveals any effect of an active ingredient on mammalian
reproduction

A

Reproduction studies

38
Q

Evaluated for anatomical abnormalities, growth &
development: maternal parent, fetus, neonates & weaning
offspring

A

Reproduction studies

39
Q

Fertility & mating behavior, mutagenicity, teratology

A

Reproduction studies

40
Q

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

A

Genotoxicity or Mutagenicity Studies

41
Q

Used in assays to detect mutations: Strains of Salmonella
typhimurium

A

Genotoxicity or Mutagenicity Studies

42
Q

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

A

Preformulation studies

43
Q

Enumerate what are studied at preformulation studies

A

Drug solubility
Partition Coefficient
Dissolution Rate
Physical Form
Stability

44
Q

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

A

Drug Solubility

45
Q

may exhibit incomplete,
erratic, and/or slow absorption thus produce
minimal response at desired dosage

A

Poor soluble compounds

46
Q

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

A

Drug’s Partition Coefficient

47
Q

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

A

Dissolution Rate

48
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 Form

49
Q

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

A

Stability

50
Q
A