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Journal of Biopharmaceutical Statistics Volume 20, 2010 - Issue 4
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Original Articles

Establishing Bioequivalence in Complete and Incomplete Data Designs Using AUCs

Thomas Jaki Department of Mathematics and Statistics, Lancaster University, Lancaster, United KingdomCorrespondence[email protected]
,
Martin J. Wolfsegger Global Biopharm Preclinical Research and Development, Baxter Innovations GmbH, Vienna, Austria
&
John-Philip Lawo Global Biopharm Preclinical Research and Development, Baxter Innovations GmbH, Vienna, Austria
Pages 803-820 | Received 29 Sep 2008, Accepted 27 Apr 2009, Published online: 19 May 2010

Citations (8)

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Read on this site (2)

Steven Y. Hua, D. L. Hawkins & Jihao Zhou. (2013) Statistical considerations in bioequivalence of two area under the concentration–time curves obtained from serial sampling data. Journal of Applied Statistics 40:5, pages 1140-1154.
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Iris Pigeot, Dieter Hauschke & Jun Shao. (2011) The Bootstrap in Bioequivalence Studies. Journal of Biopharmaceutical Statistics 21:6, pages 1126-1139.
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Articles from other publishers (6)

Fangrong Yan, Huihong Zhu, Junlin Liu, Liyun Jiang & Xuelin Huang. (2018) Design and inference for 3-stage bioequivalence testing with serial sampling data. Pharmaceutical Statistics.
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Eduard Jirkovský, Anna Jirkovská, Jan Bureš, Jaroslav Chládek, Olga Lenčová, Ján Stariat, Zuzana Pokorná, Galina Karabanovich, Jaroslav Roh, Petra Brázdová, Tomáš Šimůnek, Petra Kovaříková & Martin Štěrba. (2018) Pharmacokinetics of the Cardioprotective Drug Dexrazoxane and Its Active Metabolite ADR-925 with Focus on Cardiomyocytes and the Heart. Journal of Pharmacology and Experimental Therapeutics 364:3, pages 433-446.
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Thomas JakiPhilip Pallmann & Martin J. Wolfsegger. (2013) Estimation in AB/BA crossover trials with application to bioequivalence studies with incomplete and complete data designs. Statistics in Medicine 32:30, pages 5469-5483.
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Thu Thuy Nguyen, Caroline Bazzoli & France Mentré. (2012) Design evaluation and optimisation in crossover pharmacokinetic studies analysed by nonlinear mixed effects models. Statistics in Medicine 31:11-12, pages 1043-1058.
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Thomas Jaki & Martin J. Wolfsegger. (2012) Non-compartmental estimation of pharmacokinetic parameters for flexible sampling designs. Statistics in Medicine 31:11-12, pages 1059-1073.
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Thomas Jaki & Martin J. Wolfsegger. (2010) Estimation of pharmacokinetic parameters with the R package PK. Pharmaceutical Statistics 10:3, pages 284-288.
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