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Activity Number:
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521
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Type:
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Invited
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Date/Time:
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Thursday, August 2, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Statisticians in the Pharmaceutical Industry
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| Abstract - #307691 |
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Title:
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Bioequivalence and the Pharmaceutical Industry
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Author(s):
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Scott Patterson*+ and Byron Jones
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Companies:
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GlaxoSmithKline and Pfizer Inc.
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Address:
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2301 Renaissance Boulevard, King of Prussia, PA, 19406,
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Keywords:
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bioequivalence ; REML ; method-of-moments
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Abstract:
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Average bioequivalence (ABE) studies have long been the regulatory standard for demonstrating that two formulations of drug product will provide the same benefit and safety profile when used in the market. Population (PBE) and Individual (IBE) BE were the subject of debate when proposed in FDA guidance in 1997. This called for the use of replicate design, cross-over studies for selected drug products and REML models for parameter estimation. Market access would be granted if the products demonstrated ABE, and sponsors had the option of using PBE or IBE if the use of these criteria could be justified. SAS-based approaches to the modeling of pharmacokinetic data from such studies will be summarized based on work published by the authors in 2002 and 2004 in Pharmaceutical Statistics, updated with recent findings.
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