Vol.42, No.2, Oct. 2014
The 12th Setouchi International Conference on Clinical Trials / The 32nd Aso-Kujyu Conference on Clinical Pharmacology
Medical Innovation Management and the trend of data standardization
 
Contents
 
EditorialNomoto M169Full text
 
The 12th Setouchi International Conference on Clinical Trials /
 The 32nd Aso-Kujyu Conference on Clinical Pharmacology
 171-230Abstract
          Organized by: Clinical Research Trial Center, Ehime University Hospital
 Opening remarksNomoto M174
 Accelerating regulatory science initiativeMiyata T175-82
 Clinical translation of hepatocyte growth factor for amyotrophic lateral sclerosisAoki M183-9
 Challenges in the academic institutionMoritoyo T190-7
 What can the Pharmaceutical Company do in the cooperation of industrial, administrative
  and academic sectors in a clinical study?
Iwasaki K 198-204
 Collaboration between academia and pharma Iwasaki M 205-10
 General discussion   211-4
 An introduction to Bayesian adaptive designLewis RJ215-29
 Closing remarksNomoto M230
 Adaptive designs in clinical trials: An overviewOrigasa H231-40Abstract
 
Medical Innovation Management and the trend of data standardization
 Medical Innovation Management: Principle and PracticeFukushima M,editor.241-394Full text
 The comment on FDA draft guidances about regulatory submissions
  in electronic format-standardized study data
Jyouno T395-402Abstract
 Guidance for Industry: Providing Regulatory Submissions in Electronic Format-
  Standardized Study Data[draft guidance]
FDA-CDER,CBER
(trans. by Jyouno T)
403-10
 
World trend of ethics and science of clinical trial  
 Interview with Dr. Robert Temple on drug evaluation policy of FDATemple R,et al.411-23Full text
 The WMA Council Session in Tokyo, 2014: Globalized medical ethics and research ethicsMungherera M,et al.425-57Full text
 Challenges in regulating biomedical research:
  The Human Subjects Research Act and the Human Biobank Management Act in Taiwan
Chen I459-66Abstract
 Trend of research ethics and conflict of interest management in Korea and Taiwan Kurihara C 467-84 Full text
 Reformation of clinical trial regulations in European Union (EU) Kurihara C 485-500 Full text
 
Instructions for authors[Japanese]&[English]  501-9 Full text
 
Editor’s noteKawai S511Full text
 
[Electronic publications only]
Articles  
 Publication denied: A case analysis of infringement of publication integrity and ethicsMatsui K,et al.513-7Full text
 Analyzing the development of ethics guidelines for nursing research in Japan Matsui K,et al. 519-30 Full text
 
Forum  
 Open dialogue approach to acute psychosisSaio T531-7Full text
 
English versions of articles in Japanese   
 Interview with Dr. Robert Temple on drug evaluation policy of FDA Temple R,et al. 539-51 Full text
 The WMA Council Session in Tokyo, 2014 Mungherera M,et al. 553-90 Full text
 Trend of research ethics and conflict of interest management in Korea and Taiwan Kurihara C 591-610 Full text


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