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Phar 303 > In Vivo Toxicity Testing > Flashcards

In Vivo Toxicity Testing Flashcards

1
Q

What are the two factors of hazard identification that tie into risk characteriation?

A

Dose-Response assessment

Exposure assessment

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2
Q

Identification of a Hazard leads to allows for ____ (4)

A
  • Epidemiology
  • Toxicology (in vivo)
  • In vitro tests
  • Structure-activity analyses
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3
Q

True/False? Academic institutions always follow strict guidelines.

A

False

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4
Q

True/False? All drugs developed for human use are tested.

A

True

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5
Q

True/False? Most chemicals in commerse today have been tested as safe.

A

False, most of them haven’t been tested at all (yikes)

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6
Q

What is the OECD?

A

Organisation for Economic Co-operation and Development

Guidelines for the testing of chemicals (~100 most relevant methods of testing)

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7
Q

What is the testing scheme for new chemicals? (8 steps)

A
  • Test material identification
  • Chemical characterisation
  • Literature review
  • Structure/activity assessment
  • Short term animal studies
    • in vitro genetic toxicity
    • metabolism/pharmacokinetics
  • subchronic toxicity
  • specialized results
    • Reproductive/teratology
    • Chronic toxicity
    • Oncogenicity
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8
Q

What do the Screening Information Data Set tests cover? (6 things)

A
  • acute toxicity
  • chronic toxicity
  • developmental and reproductive toxicity
  • mutagenicity
  • ecotoxicity
  • environmental fate
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9
Q

True/False? Most of the 3000 high production volume chemicals are missing one or more of the SIDS tests?

A

True, 93%

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10
Q

True/False? Almost half of the 3000 high production volume chemicals are missing all of the SIDS tests?

A

True, 43%

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11
Q

True/False? Approximately one third of the 3000 high production volume chemicals have all six of the SIDS tests

A

False, 7%

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12
Q

What are the EPAs problems regarding toxicity data?

A

Too many chemicals, too little data

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13
Q

What are the three most used animals for testing?

A

Mice, birds and fish

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14
Q

True/false? The amount of animals killed for research and education is larger than any other category of animals killed

A

False (opposite is true)

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15
Q

True/False? On the basis of dose per unit of body mass, toxic effects in humans are usually in the same dose range as those for experimental animals.

A

False, basis of dose per unit of body surface

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16
Q

True/False? Increasing sample size gives better results.

A

…

17
Q

Define point of departure

A

The point at which extrapolation from experimental data begins

18
Q

How many animals are typically used in a cohort analysis?

A

140

19
Q

What is the time span of a subacute test?

A

8 months

20
Q

What is the time span of a subchronic test?

A

12 months

21
Q

What is the time span of a chronic test?

A

45 months

22
Q

What are the 5 objectives of long term toxicity testing?

A
  • Determine therapeutic margins in the species studied
  • Determine dose-response relationship of behavioural, functional, and histopathological effects of a drug when administered repeatedly
  • Determine the target organs for potential toxicity
  • Determine the existence of speices and sex difference
  • Determine whether the toxicity is reversible
23
Q

How do carcinogenic/mutagenetic studies differ in practice from in theory?

A

It’s expensive

24
Q

Why are males exposed for 60 days in a developmental/reproductive study as opposed to 14 days in females?

A

Spermatogenesis takes approximately 2 months

25
Q

How do you test the quality of vaccines/other drugs of biological origin?

A

Biological testing:
A vaccine/drug is given to a group, then a target disease is administered to that group and another unprotected group. The resultant illness is then compared

26
Q

Describe the Ames test and what its goal is.

A

Incubate different bacterial strains with homogenized rat liver to see if it can mutate and grow on histidine-deficient media.

27
Q

Name 4 model organisms learned in class

A

Drosophila (my boys)
Zebrafish
Xenopus (badass name for frogs, but literally means “weird feet”)
Transgenic Mice

28
Q

What is the main characteristic shared by almost all descriptive toxicity tests?

A

It’s expensive as FUCK
(Like it costs $160000 to get some rats to fuck
(That’s wack))

Phar 303 (19 decks)

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