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Concept for Establishment of Rat Outbred Global Standard Strains
Pages 65-76

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From page 65...
... The animals for this purpose must be "carefully selected standardized outbred rats of the same strain," which can be used on an international level in safety studies to achieve reproducibility and comparability of results. This condition requires reliable genetic and microbiologic quality standards and test methods.
From page 66...
... Global standards of outbred rat strains cannot be established without evaluation of genetic profiles as a scale; however, no methods have been available to establish such profiles in outbred rats. In 1990, we studied outbred stocks of rats using the genetic monitoring system, and genetic testing methods to confirm the genetic quality of outbred stocks were established (Katoh and others 1998~.
From page 68...
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From page 69...
... In I_ · — . io~ F ~ `.r 1 r~ ~ '~ A;_ ~ o In O ~ Gene Frequency W)
From page 70...
... A .. FIGURE 4 Concept for establishing global standards of outbred rats.
From page 71...
... Generational stability of gene frequency Stability of the gene frequency profile must be assured over time by the established test methods. SELECTION OF A GLOBAL STANDARD OUTBRED RAT STRAIN One standard strain was selected by the following method based on the concept described above.
From page 72...
... 72 U a_ Cal o Cal sly o o ·_' o Cal ;^ Cal o = Cal to ~3
From page 73...
... 73 no V _ _ ~ _ V IS — is: ._: A_ Cal Cal so so o Cal ·_.
From page 75...
... 1981-1998) Body weight, Food consumption, Survival rates Clinical biochemistry, Hematology, Urinanalysis Malformation rates in reproduction studies Spontaneous abnormal fin din gs 2 year study data on control rats (N=l2O, 1996-9} Non-neoplastic lesions ~ ~, Pre- i03 weeks Non-neoplastic lesions ~ ~ ~ Post- 703 weeks Neoplastic lesions (~ ~ Pre- i03 weeks ~ Neoplastic lesions ~ ~ ~ Post- i03 weeks J FIGURE 8 Compiled background data of Wistar Hannover rats (Hanlbm:WIST)
From page 76...
... A global distribution system of quality controlled standardized outbred rats covering Europe, the Americas, and Asia must be established. Breeders that can assure reliable quality control must be selected in each region, and an alliance should be formed to supply outbred rats of uniform quality.


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