BB LRGPHOR Ch12 - Toxicity Testing in Rabbits Flashcards Preview

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Flashcards in BB LRGPHOR Ch12 - Toxicity Testing in Rabbits Deck (40):
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1. The domestic rabbit used in research is

Oryctolagus cuniculus

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2. Breeds of rabbits commonly used in research include
a. New Zealand White
b. Japanese albino
c. Dutch Belted
d. all of the above

d

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3. Advantages of using the Dutch Belted rabbit over the albino rabbits is
a. smaller size of Dutch Belted requires about 40% less test material
b. effects of test materials on melanocytes may be studied
c. a and b
d. none of the above

c

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4. True or False: Himalayan rabbits, primarily used in Europe, have reproductive data similar to other breeds used in research.

True

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5. Other breeds sometimes used in research include
a. Flemish Giant
b. Polish
c. Red Burgundy
d. all of the above

d

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7. True or False: Stepwise acclimitation to once-daily limited feeding is commonly done prior to experimental procedures to avoid gastrointestinal upset, diarrhea, and poor health.

True

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9. True or False: Rabbits may be a better model than rats to study hepatotoxicity of antibiotics in humans.

True

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10. The following are suitable models of toxic shock syndrome due to Staphylococcus aureus
a. New Zealand White rabbit
b. Dutch-Belted rabbit
c. baboon
d. a and c

d

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11. True or False: Ochratoxin A and Citrinin are two mycotoxins formed in improperly stored feed. These toxins are nephrotoxic in animals and have been shown to be immunotoxic in New Zealand White rabbits.

True

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12. In vitro models developed in rabbits to investigate nephrotoxicity include
a. isolated perfused kidney
b. isolated glomeruli and isolated perfused tubules
c. renal cortical slices and proximal tubule cell cultures
d. all of the above

d

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13. Because the rabbit renal system is sensitive to contrast agents, in vivo rabbit models have been useful to evaluate toxicity of contrast being developed for use in
a. radiography
b. ultrasound
c. computed tomography
d. all of the above

d

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14. True or False: Due to differences in renal accumulation, compared to mice and rats, rabbits are more sensitive to nephrotoxic effects of cephalosporins.

True

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15. Single i.v. injection of cephaloridine in New Zealand White (NZW) rabbits results in
a. bilateral proximal convoluted tubule necrosis
b. aminoaciduria and lactic aciduria
c. glycosuria
d. all of the above

d

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16. The rabbit has proven a useful model for
a. cyclosporine A nephrotoxicity
b. rapamycin nephrotoxicity
c. cephalosporin nephrotoxicity
d. all of the above

d

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17. Rabbits are considered a relevant animal model of Alzheimer disease because
a. rabbits consistently develop neurofibrillary tangles
b. rabbits are sensitive to aluminum induced neurotoxicity
c. rabbits develop cognitive dysfunction
d. all of the above

d

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18. True or False: A rabbit model has been used to elucidate the mechanism of methotrexate teratogenicity and to investigate protective strategies.

True

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20. True or False: Dose-range finding, screening and pilot studies may legally be conducted in a non GLP manner.

True

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21. In an effort to reduce the number of animals used in safety testing and to refine animal testing strategies, which of the following approaches have been taken?
a. testing only one relevant species for embryo/fetal toxicity when more than one relevant model for humans exists
b. using a tiered approach or step-wise approach to toxicity testing
c. delaying in vivo studies until late in the development process
d. all of the above

d

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23. True or False: No in vivo studies are required for substances with predictable corrosive properties.

True

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24. True or False: Rabbits have provided useful in vitro and in vivo models to identify drugs that may aggravate or cause cardiac arrhythmias or that cause prolongation of QT interval.

True

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25. True or False: Prolongation of QT interval on the electrocardiograph may deteriorate into ventricular fibrillation.

True

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26. The ____________model is a multicellular in vitro action potential model comprised of a single cell population that homogeneously expresses the major ion channels. This model is a surrogate for in vivo electrocardiogram studies.

rabbit Purkinje fiber

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27. The arterially perfused rabbit ventricular wedge preparation is an in vitro action potential model that
a. preserves cell coupling
b. is considered better than dog or guinea pig
c. has long viability
d. all of the above

d

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28. The __________model is an in vitro action potential rabbit model that preserves functional anatomy without interferences of cardiovascular reflexes.
a. arterially perfused rabbit ventricular wedge preparation
b. “SCREENIT”
c. isolated whole-heart
d. b and c

d

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29. The typical non-rodent species used in repeat-dose cardiovascular toxicity in vivo studies is
a. dog
b. monkey
c. rabbit
d. a and b

d

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30. True or False: Rabbits are a relevant in vivo model for cardiovascular risk because the ion channels controlling ventricular repolarization are similar in rabbits and humans.

True

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31. True or False: Generally, in the assessment for the potential of developmental and reproductive toxicity (DART), positive control groups are not required.

True; interpretation is made using concurrent controls and historical control data from the testing institution using the same species and strain.

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32. True or False: The International Conference on Harmonisation (ICH) issued guidelines for safety testing of pharmaceutical drugs in an effort to reduce duplication of studies and unnecessary use of animals to meet regional global marketing requirements. These guidelines have been adopted by the United States FDA, Japan and the European Union.

True

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33. ICH guidelines emphasize all endpoints of developmental toxicity including
a. malformations and embryo lethality
b. reduced weight
c. functional or behavioral changes
d. all of the above

d

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54. Rabbits provide a good model in which to evaluate vaccine safety because
a. most human vaccines are immunogenic in rabbits
b. similar to humans, most of the antibody induced in rabbits is transplacentally transferred (in contrast in rodents most antibody is transferred postnatally in the milk)
c. a full human dose of vaccine can easily be administered to rabbits by a variety of routes
d. all of the above

d

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59. In the ocular irritation and toxicity study, eyes are examined at __________hrs after instillation of test material

24, 48, 72 hr

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60. In the ocular irritation and toxicity study, in order to determine reversibility of ocular damage, eyes are examined for __________days.

14-21

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62. In the dermal irritation tests animals are observed
a. within 30 minutes of application of test material
b. periodically within the first 24 hrs with particular attention to the first 4 hrs after application of test material
c. daily for 14 days
d. all of the above

d

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63. True or False: In the dermal irritation test, repeat administration of test material is separated by _________ days to assess delayed toxicity.

3-4

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68. True or False: Comedonicity testing in rabbit ears is more sensitive than testing in human skin.

True

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69. True or False: A positive pyrogenicity test indicates microbial contamination of parenteral product.

True

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70. True or False: A common cause of positive pyrogenicity tests is endotoxin derived from E.coli, Salmonella or Shigella.

True

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71. The Limulus Amebocyte lysate test
a. uses lysates of circulating amoebas from horse shoe crabs
b. is an in vitro clotting test
c. detects only pyrogens derived from lipopolysaccharide of Gram-negative bacteria
d. all of the above

d

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72. True or False: Rabbits have proven useful models of metabolism for drug therapies in humans because they have the full range of hepatic cytochrome P450 isoenzymes.

True

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73. Examples of similarities in rabbit and human metabolism include
a. genetic polymorphisms in N-acetyltransferase activity
b. biotransformation of aryl-amine drugs
c. protein-binding profile of prednisolone in rabbits more similar to humans than dogs or rats
d. all of the above

d