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Activity Number:
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25
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Type:
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Contributed
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Date/Time:
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Sunday, July 29, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309700 |
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Title:
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Statistical Consideration in the Evaluation of Red Blood Cell Products
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Author(s):
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Jeongsook Kim*+ and Tie-Hua Ng
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Companies:
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Food and Drug Administration and Food and Drug Administration
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Address:
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1401 Rockville Pike, Rockville, MD, 20852,
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Keywords:
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in vivo RBC survival ; confidence interval ; population proportion of successes ; radiolabeled RBC
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Abstract:
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This presentation discusses the acceptance criteria for autologous 24-hour radiolabeled red blood cell in vivo survival studies in the evaluation of RBC products. The current acceptance criteria is based on the individual unit RBC survival, that is a one-sided 95% lower confidence limit for the population proportion of successes >70%, where a "success" is defined as an individual unit whose in vivo RBC survival is at least 75%. Alternative approaches to meeting this acceptance criterion will be discussed.
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