Literature DB >> 16084844

Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan.

Yoshiaki Uyama1, Taro Shibata, Naomi Nagai, Hideki Hanaoka, Satoshi Toyoshima, Kazuhiko Mori.   

Abstract

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Year:  2005        PMID： 16084844     DOI： 10.1016/j.clpt.2005.04.001

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


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  9 in total

1.  Effects of teriparatide in Japanese and non-Japanese populations: bridging findings on pharmacokinetics and efficacy.

Authors:  Mika Tsujimoto; Kazunori Uenaka; Atsuko Iwata; Yoshihiro Higashiuchi; Hideaki Sowa
Journal:  J Bone Miner Metab       Date:  2011-09-21       Impact factor: 2.626

2.  Race differences: modeling the pharmacodynamics of rosuvastatin in Western and Asian hypercholesterolemia patients.

Authors:  Juan Yang; Lu-jin Li; Kun Wang; Ying-chun He; Yu-cheng Sheng; Ling Xu; Xiao-hui Huang; Feng Guo; Qing-shan Zheng
Journal:  Acta Pharmacol Sin       Date:  2010-12-13       Impact factor: 6.150

3.  Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

Authors:  Hideki Maeda; Tatsuo Kurokawa
Journal:  Int J Clin Oncol       Date:  2015-04-03       Impact factor: 3.402

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.  Pharmacokinetics and pharmacodynamics of single-dose oral tolvaptan in fasted and non-fasted states in healthy Caucasian and Japanese male subjects.

Authors:  Susan E Shoaf; Seong Ryul Kim; Patricia Bricmont; Suresh Mallikaarjun
Journal:  Eur J Clin Pharmacol       Date:  2012-05-15       Impact factor: 2.953

6.  Efficacy and safety of once-monthly risedronate in osteoporosis subjects with mild-to-moderate chronic kidney disease: a post hoc subgroup analysis of a phase III trial in Japan.

Authors:  Toshitsugu Sugimoto; Daisuke Inoue; Masayuki Maehara; Ichiro Oikawa; Takashi Shigematsu; Yoshiki Nishizawa
Journal:  J Bone Miner Metab       Date:  2018-12-06       Impact factor: 2.626

7.  Effects of teriparatide in Chinese and Caucasian women with osteoporosis: bridging study on efficacy.

Authors:  Zhongjian Xie; Yun Chen; Sirel Gurbuz; Bin Zhang; Yujie Li; Fan Bai; Yu Chen
Journal:  Clin Interv Aging       Date:  2019-05-27       Impact factor: 4.458

Review 8.  Model-informed assessment of ethnic sensitivity and dosage justification for Asian populations in the global clinical development and use of cladribine tablets.

Authors:  Alain Munafo; Nadia Terranova; Dandan Li; Ping Liu; Karthik Venkatakrishnan
Journal:  Clin Transl Sci       Date:  2021-10-26       Impact factor: 4.689

Review 9.  Toward Optimum Benefit-Risk and Reduced Access Lag For Cancer Drugs in Asia: A Global Development Framework Guided by Clinical Pharmacology Principles.

Authors:  K Venkatakrishnan; C Burgess; N Gupta; A Suri; T Takubo; X Zhou; D DeMuria; M Lehnert; K Takeyama; S Singhvi; A Milton
Journal:  Clin Transl Sci       Date:  2016-02-05       Impact factor: 4.689
  9 in total

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