Factors Affecting Drug-Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan-Reference-Cited by-同舟云学术

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

Published:2017-11-15 Issue:2 Volume:11 Page:182-188
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical And Translational Science

Author:

Asano Kunihito¹²,Uyama Yoshiaki³⁴,Tohkin Masahiro¹

Affiliation:

1. Department of Regulatory Science; Graduate School of Pharmaceutical Sciences; Nagoya City University; Nagoya Japan

2. Office of New Drug I; Pharmaceuticals and Medical Devices Agency (PMDA); Tokyo Japan

3. Office of Medical Informatics and Epidemiology; Pharmaceuticals and Medical Devices Agency (PMDA); Tokyo Japan

4. Department of Regulatory Science of Medicine; Graduate School of Medicine; Chiba University; Chiba Japan

Publisher

Wiley

Subject

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

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/cts.12520/fullpdf

Reference21 articles.

1. Labour and Welfare;Ministry of Health;Basic principles on Global Clinical Trials,2007

2. Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors;Ichimaru;Clin. Pharmacol. Ther,2010

3. Regulatory challenges in the review of data from global clinical trials: The PMDA perspective;Asano;Clin. Pharmacol. Ther,2013

4. Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects;Ando;J. Biopharm. Stat,2012

5. Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan;Shirotani;J. Clin. Pharmacol,2014

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1. Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies;Therapeutic Innovation & Regulatory Science;2024-04-04

2. Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan;Therapeutic Innovation & Regulatory Science;2023-08-16

3. Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan;Journal of Clinical Pharmacy and Therapeutics;2022-04-30

4. Asia‐inclusive global development of pevonedistat: Clinical pharmacology and translational research enabling a phase 3 multiregional clinical trial;Clinical and Translational Science;2021-02-02

5. Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan;Clinical Pharmacology & Therapeutics;2020-12-16

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