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Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics最新文献

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Report of the 3rd Annual Meeting of the Hokkaido & Tohoku Regions of the JSCPT 联委会北海道和东北地区第三届年会报告
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2019-09-30 DOI: 10.3999/jscpt.50.239
A. Inano
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引用次数: 0
Efforts to Promote and Facilitate Clinical Research Through Template Document Creation ―NIH-FDA Clinical Trial Protocol Template and the Application under Japanese Regulation― 通过模板文件创建促进和促进临床研究的努力- nih - fda临床试验方案模板和日本法规下的应用-
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2019-07-31 DOI: 10.3999/jscpt.50.183
M. Terada, M. Kobayakawa, H. Ohtsu, S. Saito, Akira Kitagawa, K. Izumi, Hiroshi Watanabe
{"title":"Efforts to Promote and Facilitate Clinical Research Through Template Document Creation ―NIH-FDA Clinical Trial Protocol Template and the Application under Japanese Regulation―","authors":"M. Terada, M. Kobayakawa, H. Ohtsu, S. Saito, Akira Kitagawa, K. Izumi, Hiroshi Watanabe","doi":"10.3999/jscpt.50.183","DOIUrl":"https://doi.org/10.3999/jscpt.50.183","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77211765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reconsideration of Assent for Pediatric Clinical Research: A Tentative Disquisition and Proposals on an “Assent Form” 对儿科临床研究同意的再思考:关于“同意书”的初步探讨与建议
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-11-30 DOI: 10.3999/jscpt.49.219
K. Matsui, Kaori Doi
{"title":"Reconsideration of Assent for Pediatric Clinical Research: A Tentative Disquisition and Proposals on an “Assent Form”","authors":"K. Matsui, Kaori Doi","doi":"10.3999/jscpt.49.219","DOIUrl":"https://doi.org/10.3999/jscpt.49.219","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78402489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Checklist in Reviewing Early-Stage Clinical Studies 回顾早期临床研究的检查表
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-09-30 DOI: 10.3999/jscpt.49.183
The Japanese Society of Clinical Pharmacology and Therapeutics
{"title":"Checklist in Reviewing Early-Stage Clinical Studies","authors":"The Japanese Society of Clinical Pharmacology and Therapeutics","doi":"10.3999/jscpt.49.183","DOIUrl":"https://doi.org/10.3999/jscpt.49.183","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85397246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
The Role of Consultation Services for Clinical Study Participants: a Survey of Progress on the Five Year Activation Plan for Clinical Study/Trial 2012 咨询服务对临床研究参与者的作用:2012年临床研究/试验五年激活计划进展调查
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-05-31 DOI: 10.3999/jscpt.49.127
Sawako Hattori, K. Aizawa, Haruko Yamamoto, Shimon Tashiro, K. Matsui
{"title":"The Role of Consultation Services for Clinical Study Participants: a Survey of Progress on the Five Year Activation Plan for Clinical Study/Trial 2012","authors":"Sawako Hattori, K. Aizawa, Haruko Yamamoto, Shimon Tashiro, K. Matsui","doi":"10.3999/jscpt.49.127","DOIUrl":"https://doi.org/10.3999/jscpt.49.127","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79090360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
6． 医薬品開発におけるレギュラトリーサイエンスの果たす役割 —臨床薬理領域— 6。常规科学在药物开发中扮演的角色——临床药理领域——
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-03-31 DOI: 10.3999/JSCPT.49.97
尚美 永井
{"title":"6． 医薬品開発におけるレギュラトリーサイエンスの果たす役割 —臨床薬理領域—","authors":"尚美 永井","doi":"10.3999/JSCPT.49.97","DOIUrl":"https://doi.org/10.3999/JSCPT.49.97","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"34 1","pages":"97-104"},"PeriodicalIF":0.0,"publicationDate":"2018-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76005717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Report of the 2nd Annual Meeting of the Kanto & Koushinetsu Regions of the JSCPT 联委会关东地区和Koushinetsu地区第二次年会报告
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-03-31 DOI: 10.3999/JSCPT.49.105
T. Shiga
{"title":"Report of the 2nd Annual Meeting of the Kanto & Koushinetsu Regions of the JSCPT","authors":"T. Shiga","doi":"10.3999/JSCPT.49.105","DOIUrl":"https://doi.org/10.3999/JSCPT.49.105","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"37 1","pages":"105-108"},"PeriodicalIF":0.0,"publicationDate":"2018-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79899985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacokinetics and Pharmacodynamics of a Single Dose of Scopolamine Ointment Applied to the Postauricular Area in Healthy Subjects 单剂量东莨菪碱软膏应用于健康人耳后区域的药代动力学和药效学
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-03-31 DOI: 10.3999/JSCPT.49.53
M. Maeda, T. Fujita, H. Amano, H. Kohara, A. Yamazaki, T. Hirayama, M. Kuroyama, M. Ogino, K. Nagashima, T. Akutsu, K. Nishiyama, Y. Kumagai
{"title":"Pharmacokinetics and Pharmacodynamics of a Single Dose of Scopolamine Ointment Applied to the Postauricular Area in Healthy Subjects","authors":"M. Maeda, T. Fujita, H. Amano, H. Kohara, A. Yamazaki, T. Hirayama, M. Kuroyama, M. Ogino, K. Nagashima, T. Akutsu, K. Nishiyama, Y. Kumagai","doi":"10.3999/JSCPT.49.53","DOIUrl":"https://doi.org/10.3999/JSCPT.49.53","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"34 1","pages":"53-58"},"PeriodicalIF":0.0,"publicationDate":"2018-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81154428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
4．レギュラトリーサイエンス研究の最前線 ： バイオマーカーを利用した分子標的薬の有効性 ・ 安全性の効果的評価法の確立 4。常规科学研究前沿:建立利用生物标志物的分子靶向药物有效性、安全性的有效评价方法
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-03-31 DOI: 10.3999/jscpt.49.87
正博 頭金
{"title":"4．レギュラトリーサイエンス研究の最前線 ： バイオマーカーを利用した分子標的薬の有効性 ・ 安全性の効果的評価法の確立","authors":"正博 頭金","doi":"10.3999/jscpt.49.87","DOIUrl":"https://doi.org/10.3999/jscpt.49.87","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"2 1","pages":"87-90"},"PeriodicalIF":0.0,"publicationDate":"2018-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90610851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implementation of Clinical Research Coordinator Hospital Certification Course to Spread Understanding of Clinical Trials 实施临床研究协调员医院认证课程，传播对临床试验的认识
Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2018-02-23 DOI: 10.3999/JSCPT.49.7
Toshiko Miyamoto, Akiyo Akaishi, Tomoko Takagai, K. Kida, M. Akaike, H. Yanagawa
{"title":"Implementation of Clinical Research Coordinator Hospital Certification Course to Spread Understanding of Clinical Trials","authors":"Toshiko Miyamoto, Akiyo Akaishi, Tomoko Takagai, K. Kida, M. Akaike, H. Yanagawa","doi":"10.3999/JSCPT.49.7","DOIUrl":"https://doi.org/10.3999/JSCPT.49.7","url":null,"abstract":"Background and objectives: In Japan, the contribution of clinical research coordinators to trials for drug approval is now well recognized in investigators. In 2013, we initiated a clinical research coordinator hospital certification course at our facility. The purpose of the course is to pre-educate medical staff who are candidates for future roles of clinical research coordinator, and to spread recognition of clinical research. \u0000Methods: To obtain information from course participants, we conducted a qualitative study in 2014, using a focus group interview in six participants who had completed the course in 2013. The initial topic was perceptions of the course before and after participation. Other topics were the present status and issues in clinical research coordinators. \u0000Results: All participants agreed that the course was acceptable and effective in reexamining their own work and roles from the aspects of clinical research, and that the role of clinical research coordinator itself is not very familiar among staff in the facility. Some participants indicated that even their more senior coworkers have limited recognition about clinical research coordinators. \u0000Conclusion: There are few reports that deal with awareness-spreading activities that targeted facility staff in positions other than those related to clinical research. This type of education could be considered to more quickly build support of clinical research","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"34 1","pages":"7-11"},"PeriodicalIF":0.0,"publicationDate":"2018-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73109736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
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