Literature DB >> 22135052

Should clinical pharmacokinetic bridging studies between Caucasian and Asian populations be required for approval of monoclonal antibodies?

Honghui Zhou1, Yuko Tsukamoto, Hugh M Davis.   

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Year:  2011        PMID: 22135052     DOI: 10.1177/0091270011411192

Source DB:  PubMed          Journal:  J Clin Pharmacol        ISSN: 0091-2700            Impact factor:   3.126


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  9 in total

1.  Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects.

Authors:  Mary Morrison; Guiseppe Palermo; Christophe Schmitt
Journal:  Eur J Clin Pharmacol       Date:  2015-09-12       Impact factor: 2.953

2.  Population pharmacokinetic and pharmacodynamic analysis of BIIB023, an anti-TNF-like weak inducer of apoptosis (anti-TWEAK) monoclonal antibody.

Authors:  Gerald R Galluppi; Nicolas Wisniacki; Chris Stebbins
Journal:  Br J Clin Pharmacol       Date:  2016-04-08       Impact factor: 4.335

Review 3.  Clinical Development and Regulatory Pathways of Monoclonal Antibodies in Japan.

Authors:  Hua Liao; Zhaoyang Li
Journal:  Ther Innov Regul Sci       Date:  2021-11-25       Impact factor: 1.778

4.  Atezolizumab and Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma: Pharmacokinetic and Safety Assessments Based on Hepatic Impairment Status and Geographic Region.

Authors:  Colby S Shemesh; Phyllis Chan; Hui Shao; Derek-Zhen Xu; Daniel Combs; Shweta Vadhavkar; René Bruno; Benjamin Wu
Journal:  Liver Cancer       Date:  2021-06-10       Impact factor: 11.740

5.  Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of evolocumab between Caucasian and Asian populations.

Authors:  Chen Wang; Qingshan Zheng; Mingqiang Zhang; Hong Lu
Journal:  Br J Clin Pharmacol       Date:  2018-10-17       Impact factor: 4.335

6.  Pharmacokinetics and safety of golimumab in healthy Chinese subjects following a single subcutaneous administration in a randomized phase I trial.

Authors:  Yanli Zhuang; Sally Lyn; Yuan Lv; Zhenhua Xu; Esther Bouman-Thio; Tara Masterson; Joyce A Ford; Monica Keen; Kevin J Petty; Hugh M Davis; Honghui Zhou
Journal:  Clin Drug Investig       Date:  2013-11       Impact factor: 2.859

7.  Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?

Authors:  Masaru Hirano; Masanori Yamada; Toshiaki Tanaka; Toshiko Koue; Tomohisa Saito; Mitsuo Higashimori; Hisao Ochiai; Junichi Yamamoto; Saori Yaguchi; Sachiko Mita; Katsutoshi Hara
Journal:  Clin Pharmacol Drug Dev       Date:  2021-11-26

8.  Pharmacokinetics of obinutuzumab in Chinese patients with B-cell lymphomas.

Authors:  John Zhai; Yan Qin; Jun Zhu; Yuqin Song; Zhixiang Shen; Xin Du; Candice Jamois; Michael Brewster; Yuankai Shi; Jun Shi
Journal:  Br J Clin Pharmacol       Date:  2017-02-14       Impact factor: 4.335

Review 9.  Understanding Inter-Individual Variability in Monoclonal Antibody Disposition.

Authors:  Veena A Thomas; Joseph P Balthasar
Journal:  Antibodies (Basel)       Date:  2019-12-04
  9 in total

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