On assessing bioequivalence and interchangeability between generics based on indirect comparisons-Reference-Cited by-同舟云学术

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On assessing bioequivalence and interchangeability between generics based on indirect comparisons

Published:2017-05-11 Issue:19 Volume:36 Page:2978-2993
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Zheng Jiayin¹²^ORCID,Chow Shein-Chung¹²,Yuan Mengdie³

Affiliation:

1. National Clinical Research Center for Digestive Disease; Beijing Friendship Hospital, Capital Medical University; Beijing China

2. Duke University School of Medicine; 2424 Erwin Road, Hock Plaza, Suite 1102 Durham 27705 NC U.S.A.

3. Center for Drug Evaluation and Research Organization; Food and Drug Administration; Silver Spring Maryland U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference20 articles.

1. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability;Schuirmann;Journal of Pharmacokinetics and Biopharmaceutics,1987

2. Scientific factors and current issues in biosimilar studies;Chow;Journal of Biopharmaceutical Statistics,2014

3. Some thoughts on drug interchangeability;Chow;Journal of Biopharmaceutical Statistics,2016

Cited by 3 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Statistical tests for detecting reference product change in biosimilar studies;Generics and Biosimilars Initiative Journal;2023-08-15

2. Comparison between branded and generic furosemide 40 mg tablets using thermal gravimetric analysis and Fourier transform infrared spectroscopy;Journal of Pharmacy And Bioallied Sciences;2020

3. Simultaneous confidence interval methods for analytical similarity assessment;Journal of Biopharmaceutical Statistics;2019-08-27

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