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Volume 25, Issue 2

Journal of Biopharmaceutical Statistics

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Journal of Biopharmaceutical Statistics, Volume 25, Issue 2 (2015)

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Journal of Biopharmaceutical Statistics, Volume 25, Issue 2 (2015)

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Vol 34, 2024 Vol 33, 2023 Vol 32, 2022 Vol 31, 2021 Vol 30, 2020 Vol 29, 2019 Vol 28, 2018 Vol 27, 2017 Vol 26, 2016 Volume 25, 2015 Vol 24, 2014 Vol 23, 2013 Vol 22, 2012 Vol 21, 2010-2011 Vol 20, 2009-2010 Vol 19, 2009 Vol 18, 2007-2008 Vol 17, 2007 Vol 16, 2006 Vol 15, 2005 Vol 14, 2004 Vol 13, 2003 Vol 12, 2002 Vol 11, 2001 Vol 10, 2000 Vol 9, 1999 Vol 8, 1998 Vol 7, 1997 Vol 6, 1996 Vol 5, 1995 Vol 4, 1994 Vol 3, 1993 Vol 2, 1992 Vol 1, 1991

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Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design (QbD)

Guest Editorial

Guest Editors’ Note: Special Issue on Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design(QbD)

Yi Tsong & Harry Yang

Page: 233

Published online: 25 Feb 2015

CitationforGuest Editors’ Note: Special Issue on Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design(QbD) | Full Text | PDF (60.4 KB)

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Original Articles

Article

A Statistical Approach to Determining Criticality of Residual Host Cell DNA

Harry Yang, Ziping Wei & Mark Schenerman

Pages: 234-246

Published online: 25 Feb 2015

AbstractforA Statistical Approach to Determining Criticality of Residual Host Cell DNA | Full Text | References | PDF (307.3 KB)

333 Views
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Article

A Quality By Design Approach For Longitudinal Quality Attributes

Pierre Lebrun, Katherine Giacoletti, Tara Scherder, Eric Rozet & Bruno Boulanger

Pages: 247-259

Published online: 25 Feb 2015

AbstractforA Quality By Design Approach For Longitudinal Quality Attributes | Full Text | References | PDF (501.6 KB)

338 Views
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Article

Analytical Procedure Validation and the Quality by Design Paradigm

Eric Rozet, Pierre Lebrun, Jean-François Michiels, Perceval Sondag, Tara Scherder & Bruno Boulanger

Pages: 260-268

Published online: 25 Feb 2015

AbstractforAnalytical Procedure Validation and the Quality by Design Paradigm | Full Text | References | PDF (176.5 KB)

558 Views
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Article

Statistical Evaluation of Several Methods for Cut-Point Determination of Immunogenicity Screening Assay

Meiyu Shen, Xiaoyu Dong & Yi Tsong

Pages: 269-279

Published online: 25 Feb 2015

AbstractforStatistical Evaluation of Several Methods for Cut-Point Determination of Immunogenicity Screening Assay | Full Text | References | PDF (323.8 KB)

1084 Views
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Article

Statistical Considerations in Setting Product Specifications

Xiaoyu Dong, Yi Tsong & Meiyu Shen

Pages: 280-294

Published online: 25 Feb 2015

AbstractforStatistical Considerations in Setting Product Specifications | Full Text | References | PDF (507.8 KB)

1290 Views
17 CrossRef citations
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Article

Non-Normal Random Effects Models for Immunogenicity Assay Cut Point Determination

Jianchun Zhang, Binbing Yu, Lanju Zhang, Lorin Roskos, Laura Richman & Harry Yang

Pages: 295-306

Published online: 25 Feb 2015

AbstractforNon-Normal Random Effects Models for Immunogenicity Assay Cut Point Determination | Full Text | References | PDF (173 KB)

340 Views
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Article

One- and Two-Stage Arrhenius Models for Pharmaceutical Shelf Life Prediction

Zhewen Fan & Lanju Zhang

Pages: 307-316

Published online: 25 Feb 2015

AbstractforOne- and Two-Stage Arrhenius Models for Pharmaceutical Shelf Life Prediction | Full Text | References | PDF (263.4 KB)

599 Views
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Article

Using Tolerance Intervals for Assessment of Pharmaceutical Quality

Xiaoyu Dong, Yi Tsong, Meiyu Shen & Jinglin Zhong

Pages: 317-327

Published online: 25 Feb 2015

AbstractforUsing Tolerance Intervals for Assessment of Pharmaceutical Quality | Full Text | References | PDF (233.9 KB)

973 Views
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Article

Quality Assurance Test of Delivered Dose Uniformity of Multiple-Dose Inhaler and Dry Powder Inhaler Drug Products

Yi Tsong, Xiaoyu Dong, Meiyu Shen & Richard T. Lostritto

Pages: 328-338

Published online: 25 Feb 2015

AbstractforQuality Assurance Test of Delivered Dose Uniformity of Multiple-Dose Inhaler and Dry Powder Inhaler Drug Products | Full Text | References | PDF (494.3 KB)

611 Views
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Article

Testing Assay Linearity Over a Pre-Specified Range

Harry Yang, Steven J. Novick & David LeBlond

Pages: 339-350

Published online: 25 Feb 2015

AbstractforTesting Assay Linearity Over a Pre-Specified Range | Full Text | References | PDF (216.7 KB)

225 Views
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Article

Dissolution Curve Comparisons Through the F₂ Parameter, a Bayesian Extension of the f₂ Statistic

Steven Novick, Yan Shen, Harry Yang, John Peterson, Dave LeBlond & Stan Altan

Pages: 351-371

Published online: 25 Feb 2015

AbstractforDissolution Curve Comparisons Through the F₂ Parameter, a Bayesian Extension of the f₂ Statistic | Full Text | References | PDF (347.6 KB)

403 Views
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Journal of Biopharmaceutical Statistics (Vol.25, Iss.2, 2015)

Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design (QbD)

Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design (QbD)

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