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Toxicity Testing Strategies to Determine Needs and Priorities (1984) / Chapter Skim
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3. OPERATING POLICIES FOR IDENTIFICATION, ACQUISITION, AND ORGANIZATION OF DATA
Pages 51-54

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From page 51...
... Operating policies were established regarding the use of restricted-access or confidential information; toxicity information on humans; data on physical and chemical characteristics, manufacturing processes, production volumes, intended uses, and human exposures; chemical review articles; articles in foreign languages; and information on compounds structurally similar to those in the subsample. These policies are discussed below.
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From page 53...
... ; this procedure may have excluded some preclinical and clinical data contained in inaccessible FDA files. CHEMI CAL AND PHYSI CAL CEIARACTERI ST ICS, bLANUFACTURI NG PROCESSES, PRODUCTION VOLUMES, INTENDED USES, AND EXPOSURE OF HUMANS Information on these subjects included all the data elements listed in the "Physicochemical, Use, and Exposure Information" section 53 l
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From page 54...
... for a given substance had been identified, the data search was continued only for the required test types that were still missing. The committee recognizes that unrequited test types may not have been found for substances with large data bases, but any such omissions would not affect the committee's assessment of toxicity-testing needs.
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Key Terms

  • data elements
  • test types
  • review articles
  • production volumes
  • confidential information

  • foreign languages
  • chemical review
  • manufacturing processes
  • required test
  • english summaries

  • confidential review
  • inaccessible fda
  • compounds structurally
  • established regarding
  • elements listed

  • fda files
  • information supplied
  • specific information
  • computerized data
  • eventually found

  • physi cal
  • data evaluation
  • human exposures
  • remained confidential
  • operating policies

  • data consistently
  • ground rules
  • maintain consistency
  • computer citations
  • initial screening


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