Rinsho Hyoka(Clinical Evaluation)

Supplement

Supplement

year
volume
number
article's title
author
1980 8 Sup.1 FDA Bureau of Drugs Clinical Guidelines FDA
1983 11 Sup.2   The Controller Committee
1985 13 Sup.3 Recent Topics on Clinical Trials The Controller Committee
1987 15 Sup.4   The Controller Committee
1990 18 Sup.5 FDA Bureau of Drugs Clinical Guidelines U FDA
1992 20 Sup.6 Clinical and Statistical Aspects of Drug Approval The Controller Committee
1993 21 Sup.7 "Drug Approval and Clinical Trials"
|
Practical Problems for Clinical Investigators and Researchers|
The Controller Committee
1994 22 Sup.8   FDA (translator: Keiji Ueda, Yoshihito Omori, The Controller Committee)
1995 23 Sup.9 Recent Topics on Switched OTC in USA FDA (translator: Naokata Shimizu)
1996 24 Sup.10 Guideline for Good Clinical Practice ICH Harmonised Tripartite Guideline The Controller Committee
1997 24 Sup.11   The Controller Committee
1997 25 Sup.12   The Controller Committee
1999 26 Sup.13 Evidence of Off-Label Use of Drug Kiichiro Tsutani, Naokata Shimizu
2000 27 Sup.14 World wide view on development and evaluation of switched and direct OTC  
2001 28 Sup.15 Bridging Strategies Ed. by Stephen W. Lagakos & Masahiro Takeuchi
2001 29 Sup.16 Clinical Evaluation of OTC Drugs and Traditional Drugs Ed. by Naokata Shimizu, Kiichiro Tsutani
2002 29 Sup.17 Bridging Strategies and Pharmacogenomics Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2003 30 Sup.18   Ed. by Naokata Shimizu, Syozo Koshikawa,
Takeo Nomura, Gotaro Toda
2003 30 Sup.19 Simultaneous, Worldwide Development Strategies Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2004 31 Sup.20 Forefront of New Drug Development Strategies Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2004 32 Sup.21 Scientific and ethical evaluation of regenerative medicine
Focus on bone marrow and fetal stem cell clinical research
 
2005 32 Sup.22 Global Development Strategies of New Drugs Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2006 33 Sup.23 Development, Evaluation and Approval of New Drugs Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2006 34 Sup.24 What is the TGN 1412 case ?  
2007 35 Sup.25 Japan's Critical Path Opportunities Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2009 36 Sup.26 Clinical science : Principles and practice| Science, law and humanity|  
2009 37 Sup.27 Learning from Experience and New Challenges for the Future Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2010 37 Sup.28 Significance of Asian Studies in Simultaneous Global Clinical Trials Ed. by Masahiro Takeuchi & Stephen W. Lagakos
2011 39 Sup.29 Innovative Strategies for Future Objectives Ed. by Masahiro Takeuchi & Lee Jen Wei
2012 40 Sup.30 Innovative Strategies for Enhancing Regional Drug Development as a Global Drug Development Ed. by Masahiro Takeuchi & Lee Jen Wei
2012 40 Sup.31 Public Debriefing Session 2011  
2014 42 Sup.32 Next Steps and Actions as one of the Leading Countries Ed. by Masahiro Takeuchi & Lee Jen Wei
2014 42 Sup.33 Public Debriefing Session 2013  
2015 43 Sup.34 Moving beyond the Comfort Zone Ed. by Masahiro Takeuchi & Lee Jen Wei
2015 43 Sup.35 Public Debriefing Session 2014  

up date 2015/12/04

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