Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries-Reference-Cited by-同舟云学术

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

Published:2015 Issue:2 Volume:28 Page:57-64
ISSN:0914-9198
Container-title:Journal of Toxicologic Pathology
language:en
Short-container-title:J Toxicol Pathol

Author:

Anzai Takayuki¹,Kaminishi Masamichi¹,Sato Keizo¹,Kaufman Laura²,Iwata Hijiri³,Nakae Dai⁴

Affiliation:

1. Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-0064, Japan

2. PDS Life Sciences, 100 Valley Road, Suite 204, Mt. Arlington, NJ 07856, U.S.A.

3. LunaPath LLC, Aoihigashi 3-5-1, Naka-ku, Hamamatsu-shi, Shizuoka 433-8114, Japan

4. Department of Nutritional Science and Food Safety, Faculty of Applied Biosciences, Tokyo University of Agriculture, 1-1-1 Sakura-ga-Oka, Setagaya, Tokyo 156-8502, Japan

Publisher

Japanese Society of Toxicologic Pathology

Subject

Toxicology,Pathology and Forensic Medicine

Link

https://www.jstage.jst.go.jp/article/tox/28/2/28_2015-0007/_pdf

Reference13 articles.

1. 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. 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. 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. 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. 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.

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