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Research ArticleResearch

On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation

Harry Yang, Steven Novick and Richard K. Burdick
PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 547-559; DOI: https://doi.org/10.5731/pdajpst.2016.006551
Harry Yang
1MedImmune, LLC; and
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  • For correspondence: YangH@MedImmune.com
Steven Novick
1MedImmune, LLC; and
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Richard K. Burdick
2Elion Labs
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Reference

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PDA Journal of Pharmaceutical Science and Technology: 70 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 6
November/December 2016
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On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation
Harry Yang, Steven Novick, Richard K. Burdick
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 547-559; DOI: 10.5731/pdajpst.2016.006551

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On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation
Harry Yang, Steven Novick, Richard K. Burdick
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 547-559; DOI: 10.5731/pdajpst.2016.006551
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Analytical Similarity Assessment
    • 3. Comparison of Statistical Approaches with Correlation among Lots
    • 4. Mitigation of Correlation Effects
    • 5. Conclusion
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Keywords

  • Acceptance criteria
  • Analytical Similarity
  • Biosimilar
  • Equivalence Testing
  • generalized pivotal quantity
  • Stepwise approach

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