Page History

Task list for Lou Ann and Bill:

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• Clean up In Vitro MNT 
• Review GT specification and also assumptions
• finalize links to TO, DI, DU
• Clean up In Vitro Neutral Red Uptake

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• Add SPTOBID for Sponsor Tobacco Product Identifier(s) to each study TS - and will anything else come out of TS domain for us?
  • SPTOBID for Sponsor Tobacco Product Identifier

  • From the Product Description work:

    •  IN TX:   SPTOBID (like SPDEVID) for Sponsor Tobacco Product Identifier
    • TO domain (like DI) for Tobacco Product Identifiers and Descriptors
  • Add GTTSTCND  TX variable with values that tie to a smoking regimen from the TC domain 
    
    • see an example done with test data and PTTSTCND in PT domain Tobacco Product Testing - like LB [Would Findings be better?]

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• RLevering comment at bottom: I uploaded four documents related to the micronucleus assay (MN). The OECD 497 guidelines provide details related to performing the actual assay, for example the three exposure schedules (short and long term), cell lines, positive controls, use of the cytokinesis blocker cytochalasin B, etc. The Health Canada T-503 also provides guidelines for the testing of tobacco smoke in the MN assay. THe other two documents (ICH and ISO 10993) provide additional information regarding the MN assay and other genotoxicity methods for use in testing of pharmaceuticals and medical devices, all relevant to the understanding of the MN assay. 

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