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Activity Number:
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481
- Modeling, Analysis, and Assessment
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Type:
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Contributed
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Date/Time:
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Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
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Sponsor:
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Quality and Productivity Section
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Abstract #330323
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Presentation
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Title:
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Bayesian Framework for Tier 1 Analytical Biosimilarity Assessment
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Author(s):
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Yanbing Zheng* and Hesham Fahmy
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Companies:
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AbbVie and AbbVie
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Keywords:
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Biosimilarity;
Analytical;
Bayesian;
Equivalence
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Abstract:
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Demonstration of analytical biosimilarity is required for a biosimilar product development, where a proposed biosimilar is compared to the reference product to ensure they are highly similar. FDA applied a tiered approach for demonstrating analytical biosimilarity in the recently released draft guidance, where Tier 1 critical quality attributes are evaluated through statistical equivalence testing within the Frequentist paradigm. In this work, we investigate the methodologies and challenges for analytical Tier 1 biosimilarity assessment under Bayesian framework through simulation studies and compare Bayesian inference with the FDA's equivalence test approach.
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Authors who are presenting talks have a * after their name.
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