• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?

作者信息

Hirano Masaru, Yamada Masanori, Tanaka Toshiaki, Koue Toshiko, Saito Tomohisa, Higashimori Mitsuo, Ochiai Hisao, Yamamoto Junichi, Yaguchi Saori, Mita Sachiko, Hara Katsutoshi

机构信息

Translational Medicine Japan, Novartis Institutes for Biomedical Research, Novartis Pharma K.K., Tokyo, Japan.

Clinical Pharmacology Asian Hub, GlaxoSmithKline K.K., Tokyo, Japan.

出版信息

Clin Pharmacol Drug Dev. 2021 Dec;10(12):1410-1418. doi: 10.1002/cpdd.1044. Epub 2021 Nov 26.

DOI:10.1002/cpdd.1044
PMID:34837487
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9299455/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/570d/9299455/0cb47add8217/CPDD-10-1410-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/570d/9299455/0cb47add8217/CPDD-10-1410-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/570d/9299455/0cb47add8217/CPDD-10-1410-g001.jpg

相似文献

1
Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?探索日本在全球药物开发中I期研究的调查/研究：在加入全球临床试验之前有必要进行吗？
Clin Pharmacol Drug Dev. 2021 Dec;10(12):1410-1418. doi: 10.1002/cpdd.1044. Epub 2021 Nov 26.
2
A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed?日本已批准治疗性单克隆抗体的药代动力学综合综述：日本仍需要进行I期研究吗？
J Clin Pharmacol. 2014 May;54(5):483-94. doi: 10.1002/jcph.231. Epub 2014 Jan 10.
3
Assessment of the impact of Japanese-specific long-term safety data on new drug approval.评估日本特有长期安全性数据对新药审批的影响。
Clin Transl Sci. 2021 Nov;14(6):2339-2347. doi: 10.1111/cts.13098. Epub 2021 Jul 14.
4
Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors.在与种族相关的药物反应因素背景下，获得日本监管批准的有效全球药物开发策略。
Clin Pharmacol Ther. 2010 Mar;87(3):362-6. doi: 10.1038/clpt.2009.285. Epub 2010 Jan 27.
5
Approaches to Japanese dose evaluation in global drug development: factors that generate different dosages between Japan and the United States.日本在全球药物开发中剂量评估的方法：导致日本和美国之间剂量不同的因素。
Clin Pharmacol Ther. 2011 Dec;90(6):836-43. doi: 10.1038/clpt.2011.156. Epub 2011 Nov 2.
6
Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials.日本的高效临床试验：桥接研究与参与全球临床试验
J Clin Pharmacol. 2014 Apr;54(4):438-45. doi: 10.1002/jcph.216. Epub 2013 Nov 19.
7
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.评估日本和美国在药物研发启动、新药申请和批准方面的滞后情况，以及局部与多区域临床试验的影响。
Pharmaceut Med. 2021 Jul;35(4):253-260. doi: 10.1007/s40290-021-00393-w. Epub 2021 Jul 22.
8
Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects.多区域临床试验：日本对药物研发策略及日本受试者样本量的观点
J Biopharm Stat. 2012 Sep;22(5):977-87. doi: 10.1080/10543406.2012.701581.
9
[Globalization of clinical trials].[临床试验的全球化]
Gan To Kagaku Ryoho. 2003 Apr;30(4):555-65.
10
Survey of Japanese Orphan Drug Program: Factors Related to Successful Marketing Approval.日本孤儿药计划调查：与成功营销批准相关的因素。
J Clin Pharmacol. 2020 Jan;60(1):117-124. doi: 10.1002/jcph.1501. Epub 2019 Jul 31.

引用本文的文献

1
Comparison of the Incidence of Adverse Events Between Japanese and Non-Japanese Healthy Subjects in Phase I Studies: A Systematic Review and Meta-Analysis.比较 I 期研究中日健康受试者不良事件发生率：系统评价和荟萃分析。
Clin Drug Investig. 2024 Jan;44(1):11-19. doi: 10.1007/s40261-023-01327-x. Epub 2023 Dec 2.

本文引用的文献

1
New paradigm for expediting drug development in Asia.加速亚洲药物研发的新范式。
Drug Discov Today. 2020 Mar;25(3):491-496. doi: 10.1016/j.drudis.2019.12.013. Epub 2020 Jan 8.
2
Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies.中国、日本和美国的肿瘤治疗药物：药代动力学特征、给药方案及研发策略
Clin Pharmacol Ther. 2019 Jun;105(6):1303-1320. doi: 10.1002/cpt.1352. Epub 2019 Feb 25.
3
Explaining Ethnic Variability of Transporter Substrate Pharmacokinetics in Healthy Asian and Caucasian Subjects with Allele Frequencies of OATP1B1 and BCRP: A Mechanistic Modeling Analysis.
解释健康亚洲和高加索人群中 OATP1B1 和 BCRP 等位基因频率的转运体底物药代动力学的种族变异性：一种机制建模分析。
Clin Pharmacokinet. 2018 Apr;57(4):491-503. doi: 10.1007/s40262-017-0568-7.
4
Pharmacogenomics of Drug Metabolizing Enzymes and Transporters: Relevance to Precision Medicine.药物代谢酶和转运体的药物基因组学：与精准医学的相关性
Genomics Proteomics Bioinformatics. 2016 Oct;14(5):298-313. doi: 10.1016/j.gpb.2016.03.008. Epub 2016 Oct 8.
5
Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects.在健康的日本人和高加索受试者中，因卡单抗的药代动力学和药效学不存在种族差异。
Eur J Clin Pharmacol. 2015 Nov;71(11):1365-74. doi: 10.1007/s00228-015-1938-4. Epub 2015 Sep 12.
6
Racial/ethnic differences in drug disposition and response: review of recently approved drugs.药物处置和反应中的种族/民族差异：近期获批药物综述
Clin Pharmacol Ther. 2015 Mar;97(3):263-73. doi: 10.1002/cpt.61. Epub 2015 Jan 20.
7
Ethnic sensitivity assessment - pharmacokinetic comparability between Japanese and non-Japanese healthy subjects on selected mAbs.种族敏感性评估 - 选定单抗在日裔和非日裔健康受试者中的药代动力学可比性。
Expert Opin Drug Metab Toxicol. 2015 Feb;11(2):179-91. doi: 10.1517/17425255.2015.990438. Epub 2014 Dec 18.
8
Pharmacokinetics, pharmacodynamics, and tolerability of single and multiple doses of ticagrelor in Japanese and Caucasian volunteers.替格瑞洛单剂量及多剂量给药在日本和高加索志愿者中的药代动力学、药效学及耐受性
Int J Clin Pharmacol Ther. 2014 Jun;52(6):478-91. doi: 10.5414/CP202017.
9
Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and Western countries.日本与西方国家在分子靶向肿瘤药物的最大耐受剂量和批准剂量方面的差异。
Invest New Drugs. 2014 Aug;32(4):661-9. doi: 10.1007/s10637-014-0080-y. Epub 2014 Mar 11.
10
Assessment of factors associated with dose differences between Japan and the United States.评估与日本和美国之间剂量差异相关的因素。
Clin Pharmacol Ther. 2014 May;95(5):542-9. doi: 10.1038/clpt.2013.231. Epub 2013 Nov 26.