Vol.31, Suppl ]] 2004 新薬の開発戦略最前線
Forefront of New Drug Development Strategies
   
目 次
 
序 文竹内正弘(Masahiro Takeuchi)
Stephen W.Lagakos
iii
 
Faculty Members iv-xix
Program xx-xxiii
Opening Remarks and Welcoming Address井上松久(Matsuhisa Inoue)1-2
Congratulatory Remarks岸田修一(Shuichi Kishida)3-4
Welcoming AddressDelcan P. Doogan5-6
 
SESSION 1: GLOBAL PROGRAM: IS THERE A REALITY?Chairperson:
 Delcan P. Doogan
7-52
  Lessons Learned from Three Global(Mega-) Clinical Trials竹内正弘(Masahiro Takeuchi)9-16
  Clinical Perspective;
   Template on Global Clinical Study Protocols
桑原雅明(Masaaki Kuwahara)17-22
  Statistical Consideration上坂浩之(Hiroyuki Uesaka)23-30
  Cost-Trends: Comparison of the Cost;
   Japan vs. Rest of the World Including Asia
島谷克義(Katsuyoshi Shimatani)31-40
  Panel Discussion 41-52
 
SESSION 2: REGULATORY UPDATES AND CLINICAL TRENDSChairpersons:
 藤原康弘(Yasuhiro Fujiwara)
 竹内正弘(Masahiro Takeuchi)
53-126
  Review of Bridging Programs, Regulatory Successes戸高浩司(Koji Todaka)55-66
  A Case Study in the Value of Harmonisation林 憲一(Yoshikazu Hayashi)67-75
  Panel Discussion 77-84
  Large Scale Clinical Trial Network廣田光恵(Mitsue Hirota)85-91
  Industry Performance Metrics:
   How Does Japan Compare with the West?
   Are things Improving?
Stuart R. Walker93-104
  The Internet as a Means of Recruitment, Patient Education,
   Data Management and Monitoring
Stephen E. Wilson105-16
  Panel Discussion 117-26
 
SESSION 3: PRACTICAL USE OF ICH GUIDELINES FOR BRIDGING/
   GLOBAL CLINICAL TRIALS; ICH E5 Q&A  (TV-Conference)
Chairperson:
 Stephen W. Lagakos
127-57
  The ICH E5 Question and Answer Document: Status and ContentRobert T. O'Neill129-33
  Bridging Studies in Vaccines ResearchSusan S. Ellenberg135-41
  How Should We Plan and Conduct Asian Studies?
   -From the Reviewer's Viewpoint-
森 和彦(Kazuhiko Mori)143-8
  Panel Discussion 149-57
 
SESSION 4: OMICS: GENOMICS, PROTEOMICS AND METABOLOMICS
   -How Can They be Used to Enhance Product Approval?-
Chairperson:
 新井賢一(Kenichi Arai)
159-210
  How Has OMICS Influenced Paradigms?
   -How Can They be Used to Enhance Product Approval?-
Aiden C. Power161-75
  Japan Perspective on PGt/PGx in the Drug Development
   and Approval Process
東 純一(Junichi Azuma)177-87
  Japan Issues and Counter Measure for Real Implementation
   of Genome Based Clinical Trials
安田早苗(Sanae Yasuda)189-97
  Panel Discussion 199-210
 
SESSION 5: OTHER NOVEL TECHNOLOGY UPDATE:
   MODELING TECHNIQUE, BIOMARKERS,
   DISEASE SURROGATES, DATA MINING
Chairperson:
 井村裕夫(Hiroo Imura)
211-62
  Modeling Technique: Structual Cenomics/Structual Proteomics中村春木(Haruki Nakamura)213-20
  Biomarkers and Medical Imaging in Clinical TrialWayne O. Carter221-32
  Application of PK/PD Modeling in Drug DevelopmentAmarnath Sharma233-41
  Bridging Strategies Using Clinical Trial SimulationsRussell D. Wada243-51
  Panel Discussion 253-62
 
SUMMARY AND CONCLUSION 263-74
   Summary and ConclusionStephen W. Lagakos265-71
   Closing Remarks竹内正弘(Masahiro Takeuchi)273-4
 
QT Symposium(Satellite Meeting) 275-329
Opening Remarks竹内正弘(Masahiro Takeuchi)277
 
Topic 1: Non Clnical Pharmacology and
   Clinical Assessment of QT Prolongation
Chairperson:
 高橋希人(Kihito Takahashi)
 
  Non Clinical Pharmaclology; To Cover Testing Paradigms and
   Latest ICH Thinking(ICH S7B)
Robert Wallis279-95
  Clinical Assessment of QT Prolongation佐瀬一洋(Kazuhiro Sase)297-306
Topic 2: The Link Between Non-Clinical and Clinical TestingChairperson:
 佐瀬一洋(Kazuhiro Sase)
 
  The Link Between Non-Clinical and Clinical TestingMike C. Perkins307-20
Wrap Up and Conclusion(Panel Discussion)Chairperson:
 Mike C. Perkins
321-9


「臨床評価」誌 トップページへ
「臨床評価」誌 各号の目次へ