Literature DB >> 23872835

Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

K Asano1, A Tanaka, T Sato, Y Uyama.   

Abstract

Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

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Mesh：

Year:  2013        PMID： 23872835     DOI： 10.1038/clpt.2013.106

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


  11 in total

1.  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

2.  Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.

Authors:  Kimie Sai; Akiomi Yoshida; Tadaaki Hanatani; Takuya Imatoh; Masahiro Takeuchi; Mamoru Narukawa; Hiroshi Watanabe; Yoshiaki Uyama; Yoshiro Saito
Journal:  Br J Clin Pharmacol       Date:  2019-03-28       Impact factor: 4.335

3.  Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and Western countries.

Authors:  Hideki Maeda; Tatsuo Kurokawa
Journal:  Invest New Drugs       Date:  2014-03-11       Impact factor: 3.850

4.  Phase 1 study of the investigational Aurora A kinase inhibitor alisertib (MLN8237) in East Asian cancer patients: pharmacokinetics and recommended phase 2 dose.

Authors:  Karthik Venkatakrishnan; Tae Min Kim; Chia-Chi Lin; Lim Soon Thye; Wee Joo Chng; Brigette Ma; Ming Huang Chen; Xiaofei Zhou; Hua Liu; Virginia Kelly; Won Seog Kim
Journal:  Invest New Drugs       Date:  2015-06-19       Impact factor: 3.850

5.  Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials.

Authors:  Satoshi Ushijima; Naoki Matsumaru; Katsura Tsukamoto
Journal:  Pharmaceut Med       Date:  2021-07-22

Review 6.  A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan.

Authors:  Tetsuya Tanimoto
Journal:  Drug Des Devel Ther       Date:  2015-03-31       Impact factor: 4.162

7.  Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia.

Authors:  Koichi Miyazaki; Yasunori Sato; Hideki Hanaoka; Yoshiaki Uyama
Journal:  Clin Transl Sci       Date:  2017-07-04       Impact factor: 4.689

8.  Factors Affecting Drug-Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan.

Authors:  Kunihito Asano; Yoshiaki Uyama; Masahiro Tohkin
Journal:  Clin Transl Sci       Date:  2017-11-15       Impact factor: 4.689

9.  Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.

Authors:  Mototsugu Tanaka; Mayumi Idei; Hiroshi Sakaguchi; Ryosuke Kato; Daisuke Sato; Kenji Sawanobori; Shuichi Kawarasaki; Toshiyuki Hata; Asako Yoshizaki; Miki Nakamura; Mutsuhiro Ikuma
Journal:  Clin Pharmacol Ther       Date:  2020-11-15       Impact factor: 6.875

Review 10.  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
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