Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient creation of electronic SEND datasets between CROs-Reference-Cited by-同舟云学术

Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient creation of electronic SEND datasets between CROs

Published:2019 Issue:2 Volume:32 Page:119-126
ISSN:0914-9198
Container-title:Journal of Toxicologic Pathology
language:en
Short-container-title:J Toxicol Pathol

Author:

Anzai Takayuki¹,Matsuyama Takaaki¹,Wasko Michael²,Hatakeyama Hirofumi³,Horikawa Shin-ichi³,Anzai Reo⁴,Iwata Hijiri⁵,Imai Norio⁶,Mizuhashi Fukutaro⁷,Tsuboi Masaru⁸,Okuzono Takeshi⁹,Takagi Hisayoshi¹⁰,Cho Hyeon¹¹,Rong Bryan Tan Siang¹²,Masaki Fumio¹³,Nakae Dai¹⁴

Affiliation:

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

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

3. Ina Research Inc., 2148-188 Nishiminowa, Ina-shi, Nagano 399-4501, Japan

4. Faculty of Environment and Information Studies, Keio University, 5322 Endo, Fujisawa-shi, Kanagawa 252-0882, Japan

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

6. DIMS Institute of Medical Science, Inc., 64 Goura Nishiazai, Azai-cho, Ichinomiya, Aichi 491-0113, Japan

7. BioSafety Research Center Inc., 582-2 Shioshinden, Iwata, Shizuoka 437-1213, Japan

8. Drug Safety Testing Center Co., Ltd., 88-75 Shingo, Higashimatsuyama-shi, Saitama 355-0071, Japan

9. Drug Development Solutions Division, Sekisui Medical Co., Ltd., 2117 Muramatsu, Tokai, Ibaraki 319-1182, Japan

10. Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan

11. Chemon Inc., 240 Nampyeong-ro, Yangji-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, 17162, Republic of Korea

12. Prestige BioResearch Pte Ltd., 15 Tech Park Crescent, 638117 Singapore

13. CMIC Pharma Science Co., Ltd., 10221 Kobuchisawa-cho, Hokuto-shi, Yamanashi 408-0044, Japan

14. Department of Nutritional Science and Food Safety, Faculty of Applied Biosciences, Tokyo University of Agriculture, 1-1-1 Sakura-ga-oka, Setagaya-ku, 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/32/2/32_2018-0066/_pdf

Reference14 articles.

1. 1. Anzai T, Kaminishi M, Sato K, Kaufman L, Iwata H, and Nakae D. Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries. J Toxicol Pathol. 28: 57–64. 2015.

2. 2. CDISC SEND TEAM. Standard for Exchange of Nonclinical Implementation Guide (IG) Version 3.1 for Public Review as of Dec. 4, 2014. 2011, from CDISC website. http://www.cdisc.org/send.

3. 3. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Study data technical conformance guide, technical specification document, guidance for industry providing regulatory submissions in electronic format-standard study data. 2014, from FDA website: https://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf.

4. 4. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry providing regulatory submissions in electronic format-standard study data. 2014, from FDA website: https://www.fda.gov/downloads/drugs/guidances/ucm292334.pdf.

5. 5. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. DRAFT GUIDANCE: Guidance for Industry Providing Regulatory Submissions in Electronic Format- Submissions Under Section 745(a) of the Federal Food, Drug, and Cosmetic Act. 2014, from FDA website: https://www.fda.gov/downloads/Drugs/Guidances/UCM384686.pdf.

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