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Journal of Biopharmaceutical Statistics Volume 25, 2015 - Issue 2: Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design (QbD)
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Original Articles

Using Tolerance Intervals for Assessment of Pharmaceutical Quality

Xiaoyu DongOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
,
Yi TsongOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
,
Meiyu ShenOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
&
Jinglin ZhongOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
Pages 317-327 | Received 29 Sep 2014, Accepted 30 Sep 2014, Published online: 25 Feb 2015

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Baocai Guo, Wei Wang, Zhichao Wu, Xixiang He & Yumei Zhu. (2023) Exact equal-tailed β-expectation tolerance intervals for sample variances. Communications in Statistics - Simulation and Computation 52:11, pages 5309-5326.
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Aisaku Nakamura & Derek S. Young. (2023) Simultaneous tolerance intervals for linear regression models using an adjusted product set method. Communications in Statistics - Simulation and Computation 0:0, pages 1-24.
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Bernard G. Francq, Dan Lin & Walter Hoyer. (2020) Confidence and Prediction in Linear Mixed Models: Do Not Concatenate the Random Effects. Application in an Assay Qualification Study. Statistics in Biopharmaceutical Research 12:3, pages 262-272.
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Steven Novick & Buffy Hudson-Curtis. (2018) Content uniformity testing for stratified samples via parametric tolerance interval testing. Journal of Biopharmaceutical Statistics 28:3, pages 463-474.
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Yue-Ming Chen, Yu-Ting Weng, Xiaoyu Dong & Yi Tsong. (2017) Wald tests for variance-adjusted equivalence assessment with normal endpoints. Journal of Biopharmaceutical Statistics 27:2, pages 308-316.
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Yi Tsong, Xiaoyu Dong, Meiyu Shen & Richard T. Lostritto. (2015) Quality Assurance Test of Delivered Dose Uniformity of Multiple-Dose Inhaler and Dry Powder Inhaler Drug Products. Journal of Biopharmaceutical Statistics 25:2, pages 328-338.
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Articles from other publishers (15)

Hsiuying Wang. (2023) Tolerance limits for mixture‐of‐normal distributions with application to COVID ‐19 data . WIREs Computational Statistics 15:6.
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Chuanpu Hu. (2022) Variability and uncertainty: interpretation and usage of pharmacometric simulations and intervals. Journal of Pharmacokinetics and Pharmacodynamics 49:5, pages 487-491.
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Taylor Zhang, Ryan Larson, Kedar Dave, Nolan Polson & Heidi Zhang. (2021) Developing patient-centric specifications for autologous chimeric antigen receptor T cell therapies. Current Opinion in Biomedical Engineering 20, pages 100328.
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Chieh Chiang & Chin-Fu Hsiao. (2021) Tolerance interval testing for assessing accuracy and precision simultaneously. PLOS ONE 16:2, pages e0246642.
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Chieh Chiang, Chi‐Tian Chen & Chin‐Fu Hsiao. (2020) Use of a two‐sided tolerance interval in the design and evaluation of biosimilarity in clinical studies. Pharmaceutical Statistics.
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Yixuan Zou & Derek S. Young. (2020) Improving coverage probabilities for parametric tolerance intervals via bootstrap calibration. Statistics in Medicine 39:16, pages 2152-2166.
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Baocai Guo, Naifan Zhu, Wei Wang, Yurong Song & Hsiuying Wang. (2020) Exact two‐sided tolerance interval controlling tail proportions for sample variances. Quality and Reliability Engineering International 36:3, pages 1074-1085.
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Linas Mockus, Gintaras Reklaitis, Kenneth Morris & David LeBlond. (2020) Risk-Based Approach to Lot Release. Journal of Pharmaceutical Sciences 109:2, pages 1035-1042.
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Bernard G. Francq, Dan Lin & Walter Hoyer. (2019) Confidence, prediction, and tolerance in linear mixed models. Statistics in Medicine 38:30, pages 5603-5622.
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Pallavi Pawar, Sameer Talwar, Dheerja Reddy, Chandra Kanth Bandi, Huiquan Wu, Koushik Sowrirajan, Rick Friedman, German Drazer, James K. DrennenIIIIII & Fernando J. Muzzio. (2019) A “Large-N” Content Uniformity Process Analytical Technology (PAT) Method for Phenytoin Sodium Tablets. Journal of Pharmaceutical Sciences 108:1, pages 494-505.
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Yi Tsong, Tianhua Wang & Xin Hu. 2019. Pharmaceutical Statistics. Pharmaceutical Statistics 3 12 .
Martin G.C. Sarmiento, S. Chakraborti & Eugenio K. Epprecht. (2018) Exact two-sided statistical tolerance limits for sample variances. Quality and Reliability Engineering International 34:6, pages 1238-1253.
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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 .
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 227 267 .
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 11 113 .

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