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Activity Number:
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123
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305848 |
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Title:
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A Comparison of False Negative Rates from Dose-Response Relationship Test Only with Dose-Response Relationship Test Along with a Pairwise Test
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Author(s):
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Mohammad Rahman*+
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Companies:
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FDA
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Address:
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, Silver Spring, MD, ,
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Keywords:
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Abstract:
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For carcinogenicity study conducted as a part of the new drug development process, the significance of dose response relationship is used as the primary evidence for carcinogenic potential of the compound under investigation. The findings from the pairwise comparisons are generally considered to be supportive by most investigators. Since these tests are done by organ/tumor combination, there are hundreds of tests performed to assess the carcinogenic potential. These larger numbers of simultaneous tests increase the possibility of huge Type-1 error (false positive). Many multiple testing adjustment procedures have been suggested to adjust this inflated Type-1 error. Use of these procedures may reduce the Type-1 error to an acceptable level.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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