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

Harry Yang; Steven Novick; Richard K. Burdick

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 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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vol. 70 no. 6 547-559

DOI

https://doi.org/10.5731/pdajpst.2016.006551

PubMed

27325594

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 13, 2016.

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previous version (June 20, 2016 - 13:19).
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Author Information

Harry Yang1,*,
Steven Novick1 and
Richard K. Burdick2

¹MedImmune, LLC; and
²Elion Labs

↵* Corresponding Author: e-mail: YangH{at}MedImmune.com

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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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Keywords

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

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