Asia‐inclusive global development of pevonedistat: Clinical pharmacology and translational research enabling a phase 3 multiregional clinical trial

Author:

Zhou Xiaofei1,Friedlander Sharon1,Kupperman Erik1,Sedarati Farhad1,Kuroda Shingo2,Hua Zhaowei3,Yuan Ying1,Yamamoto Yuka2,Faller Douglas V.1,Haikawa Kazue2,Nakai Katsuhiko2,Bowen Sharon1,Dai Yi4,Venkatakrishnan Karthik1ORCID

Affiliation:

1. Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) Cambridge MA USA

2. Takeda Pharmaceutical Company Limited Tokyo Japan

3. Alnylam Pharmaceuticals Inc. Cambridge MA USA

4. Takeda Pharmaceutical Company Limited Beijing China

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference70 articles.

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

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

3. ICH E5.Ethnic factors in the acceptability of foreign clinical data E5(R1) 1998.https://database.ich.org/sites/default/files/E5_R1__Guideline.pdf. Accessed November 12 2020.

4. ICH E17.General principles for planning and design of multi‐regional clinical trials E17 2017.https://database.ich.org/sites/default/files/E17EWG_Step4_2017_1116.pdf. Accessed November 12 2020.

5. Targeting NEDD8-Activated Cullin-RING Ligases for the Treatment of Cancer

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