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Journal of Biopharmaceutical Statistics Volume 23, 2013 - Issue 4
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Original Articles

Establishment of an Equivalence Acceptance Criterion for Accelerated Stability Studies

Richard K. Burdick Amgen, Inc., Longmont, Colorado, USACorrespondence[email protected]
&
Leslie Sidor Amgen, Inc., Longmont, Colorado, USA
Pages 730-743 | Received 23 Sep 2011, Accepted 04 Nov 2011, Published online: 25 Jun 2013

Citations (12)

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Read on this site (2)

Kristina Flavier, James McLellan, Teslin Botoy & Kenneth C. Waterman. (2022) Accelerated shelf life modeling of appearance change in drug products using ASAPprime®. Pharmaceutical Development and Technology 27:6, pages 740-748.
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Christine P. Chan. (2016) Forced degradation studies: current trends and future perspectives for protein-based therapeutics. Expert Review of Proteomics 13:7, pages 651-658.
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Articles from other publishers (10)

Daniel Coleman & Tony Pourmohamad. (2022) Statistical considerations for design and analysis of stability, comparability and formulation tests. Pharmaceutical Statistics 22:2, pages 248-265.
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Fuat Doymaz, Brenda S. Ramirez & Chris Cherry. 2023. Principles and Practices of Lyophilization in Product Development and Manufacturing. Principles and Practices of Lyophilization in Product Development and Manufacturing 541 554 .
Christina Yassouridis, Astrid Dürauer, Theresa Scharl, Friedrich Leisch, Cécile Brocard & Anne-Luise Tscheliessnig. (2021) Strategy to equivalence testing for development and scale up of biopharmaceutical downstream processes. Chemical Engineering Science 235, pages 116497.
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Christine P. Chan. 2018. Methods for Stability Testing of Pharmaceuticals. Methods for Stability Testing of Pharmaceuticals 335 347 .
Binbing Yu, Lingmin Zeng & Harry Yang. (2017) A Risk-Based Approach to Setting Acceptance Criteria for Pharmaceutical Process Comparability. Journal of Pharmaceutical Innovation 12:4, pages 357-366.
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Binbing Yu, Lingmin Zeng & Harry Yang. (2017) Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics. Biologicals 49, pages 46-50.
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Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky & Lanju ZhangRichard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky & Lanju Zhang. 2017. Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry 329 369 .
Amanda A. Cordes, Kelly K. Arthur & John P. Gabrielson. 2016. Analytical Ultracentrifugation. Analytical Ultracentrifugation 397 418 .
Leslie Sidor. 2016. Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics. Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics 235 258 .
Fuat Doymaz, Frank Ye & Richard K. Burdick. 2015. Quality by Design for Biopharmaceutical Drug Product Development. Quality by Design for Biopharmaceutical Drug Product Development 649 659 .

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