書誌事項

新薬の開発戦略最前線

竹内正弘,S.W.ラガコス編

デジタルプレス, 2004.6

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シンヤク ノ カイハツ センリャク サイゼンセン

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注記

会期:2003年10月28日-29日

英文併載

the 4th Kitasato University-Harvard School of Public Health Symposium

内容:Global program:is there a reality?:Lessons learned from three global(mega-)clinical trials/竹内正弘著. Clinical perspective/桑原雅明著. Statistical consideration/上坂浩之著. Cost-trends/島谷克義著

Regulatory updates and cilinical trends:Review of bridging programs,regulatory successes/戸高浩司著. A case study in the value of harmonisation/林憲一著. Large scale clinical trial network/廣田光恵著. Industry performance metrics/Stuart R.Walker著. The internet as a means of recruitment,patient education,data management and monitoring/Stephen E.Wilson著

Practical use of ICH guidelines for bridging/global clinical trials;ICH E5 Q & A:The ICH E5 question and answer document/Robert T.O'Neill著. Bridging studies in vaccines research/Susan S.Ellenberg著. How should we plan and conduct Asian studies?/森和彦著

OMICS:genomics,proteomics and metabolomics:How has OMICS influenced paradigms?/Aiden C.Power著. Japan perspective on PGt/PGx in the drug development and approval process/東純一著. Japan issues and counter measure for real implementation of genome based/安田早苗著

Other novel technology update:Modeling technique/中村春木著. Biomakers and medical imaging in clinical trial/Wayne O.Carter著. Application of PK/PD modeling in drug development/Amarnath Sharma著. Bridging strategies using clinical trial simulations/Russell D.Wada著

QT symposium:Non clinical pharmacology/Robert Wallis著. Clinical assessment of QT prolongation/佐瀬一洋著. The link between non-clinical and clinical testing/Mike C.Perkins著

詳細情報

  • NII書誌ID(NCID)
    BA68890923
  • ISBN
    • 4925066099
  • 出版国コード
    ja
  • タイトル言語コード
    jpn
  • 本文言語コード
    jpn
  • 出版地
    東京
  • ページ数/冊数
    xxvii, 329p
  • 大きさ
    26cm
  • 分類
  • 件名
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