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Journal of Biopharmaceutical Statistics Volume 25, 2015 - Issue 3
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Original Articles

Multivariate Equivalence Tests for Use in Pharmaceutical Development

Thomas HoffelderBoehringer Ingelheim GmbH & Co. KG, Ingelheim, GermanyCorrespondence[email protected]
,
Rüdiger GösslBoehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany
&
Stefan WellekDepartment of Biostatistics, Central Institute of Mental Health, Mannheim, Germany;Department of Medical Biostatistics, Epidemiology and Informatics, University of Mainz, Mainz, Germany
Pages 417-437 | Received 09 Nov 2012, Accepted 24 Sep 2013, Published online: 15 Apr 2015

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Shaobo Liu, Xiaoyu Cai, Meiyu Shen & Yi Tsong. (2023) In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f2. Journal of Biopharmaceutical Statistics 0:0, pages 1-12.
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R. Arboretti, E. Carrozzo, F. Pesarin & L. Salmaso. (2018) Testing for Equivalence: An Intersection-Union Permutation Solution. Statistics in Biopharmaceutical Research 10:2, pages 130-138.
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Rosa Arboretti, Eleonora Carrozzo, Fortunato Pesarin & Luigi Salmaso. (2017) A multivariate extension of union–intersection permutation solution for two-sample testing. Journal of Statistical Theory and Practice 11:3, pages 436-448.
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Thomas Hoffelder & Stefan Wellek. (2017) Equivalence Testing With Particle Size Distribution Data: Methods and Applications in the Development of Inhalative Drugs. Statistics in Biopharmaceutical Research 9:1, pages 12-24.
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Articles from other publishers (15)

Tony Pourmohamad & Hon Keung Tony Ng. (2022) Statistical modeling approaches for the comparison of dissolution profiles. Pharmaceutical Statistics 22:2, pages 328-348.
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Gwenaël G.R. Leday, Jasper Engel, Jack H. Vossen, Ric C.H. de Vos & Hilko van der Voet. (2022) Multivariate equivalence testing for food safety assessment. Food and Chemical Toxicology 170, pages 113446.
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Thomas Hoffelder, David Leblond, Leslie Van Alstine, Dorys Argelia Diaz, Sandra Suarez-Sharp, Krista Witkowski, Stan Altan, James Reynolds, Zachary Bergeron, Kevin Lief, Yanbing Zheng & Andreas Abend. (2022) DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS. The AAPS Journal 24:3.
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Kenneth A. Rostowsky & Andrei Irimia. (2021) Acute cognitive impairment after traumatic brain injury predicts the occurrence of brain atrophy patterns similar to those observed in Alzheimer’s disease. GeroScience 43:4, pages 2015-2039.
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Andrei Irimia, Alexander S. Maher, Nikhil N. Chaudhari, Nahian F. Chowdhury & Elliot B. Jacobs. (2020) Acute cognitive deficits after traumatic brain injury predict Alzheimer’s disease-like degradation of the human default mode network. GeroScience 42:5, pages 1411-1429.
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Sandra Suarez-Sharp, Andreas Abend, Thomas Hoffelder, David Leblond, Poonam Delvadia, Elisabeth Kovacs & Dorys Argelia Diaz. (2020) In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report. The AAPS Journal 22:4.
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I. E. ShohinN. S. Bagaeva, E. A. MalashenkoV. N. Kuzina. (2020) Method of Estimating the Equivalence of Dissolution Profiles: a Modern View (Review). Drug development & registration 9:2, pages 145-150.
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Maren Eckert & Werner Vach. (2019) On the use of comparison regions in visualizing stochastic uncertainty in some two‐parameter estimation problems. Biometrical Journal 62:3, pages 598-609.
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Valentin Steinwandter, Daniel Borchert & Christoph Herwig. (2019) Data science tools and applications on the way to Pharma 4.0. Drug Discovery Today 24:9, pages 1795-1805.
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Thomas Hoffelder. (2018) Equivalence analyses of dissolution profiles with the Mahalanobis distance. Biometrical Journal 61:5, pages 1120-1137.
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Sundar Srinivasan, Danica Balsiger, Phillipe Huber, Brandon J Ausk, Steven D Bain, Edith M Gardiner & Ted S Gross. (2019) Static Preload Inhibits Loading-Induced Bone Formation. JBMR Plus 3:5, pages e10087.
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Stefan Horkovics-Kovats. (2018) Comparison of dissolution time profiles: No similarity but where is the difference?. European Journal of Pharmaceutical Sciences 121, pages 9-15.
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Thomas Hoffelder. (2018) Comparison of Dissolution Profiles: A Statistician’s Perspective. Therapeutic Innovation & Regulatory Science 52:4, pages 423-429.
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Yang Cao, Daniel Obeng, Guodong Hui, Luting Xue, Yukun Ren, Xianjie Yu, Fei Wang & Chad Atwell. (2018) Evaluating manufacturing process profile comparability with multivariate equivalence testing: Case study of cell-culture small scale model transfer. Biotechnology Progress 34:1, pages 187-195.
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Philip Pallmann & Thomas Jaki. (2017) Simultaneous confidence regions for multivariate bioequivalence. Statistics in Medicine 36:29, pages 4585-4603.
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