Art

J-GLOBAL ID：201502279107751096   Reference number：15A0745142

Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries

米国以外の国での申請非臨床試験データモデル(SEND)に対する返答

Author (6)： ANZAI Takayuki (Showa Univ. School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-0064, JPN) ,  KAMINISHI Masamichi (Showa Univ. School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-0064, JPN) ,  SATO Keizo (Showa Univ. School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-0064, JPN) ,  KAUFMAN Laura (PDS Life Sciences, 100 Valley Road, Suite 204, Mt. Arlington, NJ 07856, U.S.A.) ,  IWATA Hijiri (LunaPath LLC, Aoihigashi 3-5-1, Naka-ku, Hamamatsu-shi, Shizuoka 433-8114, JPN) ,  NAKAE Dai (Dep. of Nutritional Sci. and Food Safety, Fac. of Applied Biosciences, Tokyo Univ. of Agriculture, 1-1-1 ...)
Material： Journal of Toxicologic Pathology  (J Toxicol Pathol)
Volume： 28  Issue： 2  Page： 57-64 (J-STAGE)  Publication year： 2015 
JST Material Number： L1510A  ISSN： 0914-9198  Document type： Article
Article type： 文献レビュー  Country of issue： Japan (JPN)  Language： ENGLISH (EN)

Thesaurus term： *Food and Drug Administration ,...
Semi thesaurus term： Clinical Data Interchange Standards Consortium ,...

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JST classification (1)： Pharmaceutical affairs,pharmaceutical practice  (GU01020R)

Reference (13)：

• 1. Yamori T. Center for Product Evaluation of Pharmaceuticals and Medical Devices Agency. Request for Electronic Clinical Study Data for Pilot Project. PMDA/CPE Notification No. 0902001 September 2, 2013., from PMDS web site: http://www.pmda.go.jp/operations/shonin/info/iyaku/jisedai/file/tsuuchi_e.pdf.
• 2. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, and Ross JS. Regulatory review of novel therapeutics-comparison of three regulatory agencies. N Engl J Med. 366: 2284-2293. 2012.
• 3. CDISC SDTM TEAM Clinical Data Interchange Standards Consortium (CDISC). The Study Data Tabulation Model (SDTM) Implementation Guide version 3.2. CDISC SDTM TEAM. 2013, from CDISC web site: http://www.cdisc.org/sdtm.
• 4. U.S. Food and Drug Administration Study Data Standards for Regulatory Submissions Position Statement. September 13, 2013, from US FDA web site: http://www.fda.gov/forindustry/datastandards/studydatastandards/ucm368613.htm.
• 5. U.S. Food and Drug Administration Center for Drug Evaluation and Research. Office of Reguraoly Affaires. GDUFA Information Technology/Informatiics Plan (Draft) FY 2013 - FY 2017. September 2014, from FDA web site: http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM416856.pdf.

Terms in the title (4)： 米国 ,  非臨床試験 ,  データモデル ,  SEND