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Simultaneous Global New Drug Development最新文献

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Local Treatment Effect Estimation by Borrowing Information from Similar Regions in Multi-Regional Clinical Trials 多区域临床试验中借鉴相似区域信息的局部治疗效果评估
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-14
Hua Guo, Joshua Chen, H. Quan
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引用次数: 0
Global Drug Development: Multi-Regional Clinical Trials (MRCTs) – China's Pursuit 全球药物开发:多区域临床试验(MRCTs) -中国的追求
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-15
W. Shih, Tai Xie, Kun He
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引用次数: 0
Implementation of the ICH E17 Guideline in Japan ICH E17指南在日本的实施
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-7
Y. Aoi, Shuji Kamada, Yasuto Otsubo, Y. Uyama
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引用次数: 0
Lessons Learned from Actual Multi-Regional Clinical Trials with Signals of Treatment Effect Heterogeneity 治疗效果异质性信号多区域临床试验的经验教训
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-9
B. Binkowitz, Gang Li, H. Quan, Gordon Lan, S. P. Ouyang, W. Robieson, William Wang, Sammy Yuan, Y. Tanaka, Josh Chen, Lanju Zhang, P. Gallo
{"title":"Lessons Learned from Actual Multi-Regional Clinical Trials with Signals of Treatment Effect Heterogeneity","authors":"B. Binkowitz, Gang Li, H. Quan, Gordon Lan, S. P. Ouyang, W. Robieson, William Wang, Sammy Yuan, Y. Tanaka, Josh Chen, Lanju Zhang, P. Gallo","doi":"10.1201/9781003109785-9","DOIUrl":"https://doi.org/10.1201/9781003109785-9","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125907483","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
Analysis Models for Multi-regional Clinical Trials 多区域临床试验的分析模型
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-11
Gang Li, H. Quan, Gordon Lan
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引用次数: 0
General Introduction of E17 E17总体介绍
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-1
Y. Uyama, Yasuto Otsubo, Shuji Kamada, Yoko Aoi
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引用次数: 0
Consideration of “Ethnic Factors” in Design and Conduct of Multiregional Clinical Trials (MRCT) 多区域临床试验(MRCT)设计与实施中“民族因素”的考虑
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-3
Rominder Singh, Vibeke Bjerregaard
{"title":"Consideration of “Ethnic Factors” in Design and Conduct of Multiregional Clinical Trials (MRCT)","authors":"Rominder Singh, Vibeke Bjerregaard","doi":"10.1201/9781003109785-3","DOIUrl":"https://doi.org/10.1201/9781003109785-3","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133581879","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
Regional Sample Size Calculation in Multi-regional Equivalence and Non-inferiority Trials 多区域等效和非劣效性试验的区域样本量计算
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-19
Jason J. Z. Liao, Yaru Shi, Ziji Yu
{"title":"Regional Sample Size Calculation in Multi-regional Equivalence and Non-inferiority Trials","authors":"Jason J. Z. Liao, Yaru Shi, Ziji Yu","doi":"10.1201/9781003109785-19","DOIUrl":"https://doi.org/10.1201/9781003109785-19","url":null,"abstract":"","PeriodicalId":124380,"journal":{"name":"Simultaneous Global New Drug Development","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129267059","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
ICH E17 and MRCT: Implementation and Regulatory Perspective in China ICH E17和MRCT:中国的实施和监管前景
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-8
Xinman Zeng, Jun Wang, Zhaoyun Wang, Zhi-ming Yang, Min Li
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引用次数: 0
Statistical Considerations in Design, Execution, and Analysis of Multiregional Clinical Trials: Consistency Evaluation and Adaptive Trials 多地区临床试验设计、执行和分析中的统计学考虑:一致性评价和适应性试验
Simultaneous Global New Drug Development Pub Date : 2021-11-16 DOI: 10.1201/9781003109785-16
Lanju Zhang, W. Robieson
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引用次数: 0
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