| APEC Harmonization Center: Challenges and Issues Relating to Multiregional Clinical Trials in the APEC Region. | |
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MedLine Citation:
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PMID: 22318621 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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The Asia-Pacific Economic Cooperation (APEC) Harmonization Center (AHC) was established in 2009 with the purpose of promoting harmonization of regulatory processes for drugs and medical devices. The AHC held three training workshops on multiregional clinical trials (MRCTs); these workshops provided forums for discussing the value and potential benefits of MRCTs. Participants from regulatory agencies, the pharmaceutical industry, and academia identified many issues and made recommendations for resolving major challenges with the aim of improving the capacity of the Asia-Pacific region to carry out MRCTs. |
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Authors:
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K L Park; T G Kim; S K Seong; S Y Lee; S H Kim |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-2-08 |
Journal Detail:
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Title: Clinical pharmacology and therapeutics Volume: - ISSN: 1532-6535 ISO Abbreviation: - Publication Date: 2012 Feb |
Date Detail:
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Created Date: 2012-2-9 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372741 Medline TA: Clin Pharmacol Ther Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Cheongwon-Gun, Chungcheongbukdo, Republic of Korea. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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