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Activity Number:
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211
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305843 |
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Title:
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Study of Oncologic Treatment Effect Differences Between Gender and Age Groups
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Author(s):
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Weishi Yuan*+ and Yu-Ling Chang and Rajeshwari Sridhara
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Companies:
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FDA and FDA and FDA
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Address:
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Room 3519, Bldg 21, 10903 N Hampshire Avenue, Silver Spring, MD, ,
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Keywords:
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Treatment Differences ; Oncology ; Meta-Analysis
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Abstract:
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There is growing body of evidence reported in literature that suggest there could be potential differences between gender and/or age groups with respect to treatment effect sizes and thus probably requiring different level of dosing to achieve the same effect size. While every review of a new drug application or biologic licensing application will include analyses by gender and age group, such analyses are difficult to infer as these are post-hoc and generally lack power. In general 65 years is used as the cut-off point for reporting results by age. In this study we examine among the oncologic products approved for new indications during July 2005 to December 2007 if the magnitude of difference of treatment effects differs by gender, and if using 60 or 70 years as the cut-off point better differentiates treatment effect sizes by age.
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