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Activity Number:
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275
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Type:
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Invited
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Date/Time:
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Tuesday, August 5, 2003 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300009 |
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Title:
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A Study of Statistical Approaches for ICH-E5 Bridging Evaluation of Pharmacokinetics between Independent Populations
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Author(s):
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Scott D. Patterson*+
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Companies:
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GlaxoSmithKline
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Address:
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2301 Renaissance Blvd., RN0420, King of Prussia, PA, 19406,
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Keywords:
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Bridging ; Pharmacokinetics ; REML ; Nonparametric Bootstrap
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Abstract:
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Early-phase pharmacokinetic (PK) comparisons between populations are commonly performed as part of early-phase drug development for new chemical entities under ICH-E5 (1998). Such PK data are often simply described using basic summary statistics; however, such summaries may be misleading in the presence of confounding factors between populations (e.g. weight) impacting inference. Following a brief review of study design, the properties of metrics for the comparison of PK data will be characterized in small and large samples from parallel group studies. Inference will be illustrated using data from a recent submission. Simulation studies will also be used to characterize bias, coverage probability rates, and power and sample size requirements. Emphasis will be placed upon the practical statistical design issues and use of pharmacokinetic data in bridging assessment to enhance the understanding of the role of these data in enabling informed global clinical development.
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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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