Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey-Reference-Cited by-同舟云学术

Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey

Published:2019-12-31 Issue:4 Volume:29 Page:267-277
ISSN:1226-6051
Container-title:Korean Journal of Clinical Pharmacy
language:en
Short-container-title:Korean J Clin Pharm

Author:

Sohn Minji¹,Song Yun-Kyoung¹²,Jeon Ah Young¹³,Oh Jung Mi¹,Kim In-Wha¹

Affiliation:

1. College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University, Seoul 08826, Republic of Korea

2. College of Pharmacy, Daegu Catholic University, Gyeongsangbuk-do 38430, Republic of Korea

3. Department of Pharmacy, Seoul National University Hospital, Seoul 03080, Republic of Korea

Funder

Ministry of Food and Drug Safety

Korea Pharmaceutical and Bio-Pharma Manufacturers Association

Publisher

The Korean College of Clinical Pharmacy

Subject

General Medicine

Link

http://pdf.medrang.co.kr/KJCP/2019/029/KJCP029-04-06.pdf

Reference40 articles.

1. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E17 General principles for planning and design of Multi-Regional Clinical Trials <italic>Draft</italic> ICH 2016. Available from <uri>https://www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/ E17EWG_Step2_2016.pdf</uri> Accessed August 26, 2016

2. Weisfeld V, Lustig TA. International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary of Forum on Drug Discovery, Development, and Translation. Board on Health Sciences Policy;Institute of Medicine (IOM), Washington, Oct 24;2013:5-9.

3. Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials

4. Multi-regional clinical trials and global drug development

5. Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials

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