Leveraging the Value of CDISC SEND Data Sets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals-Reference-Cited by-同舟云学术

Leveraging the Value of CDISC SEND Data Sets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals

Published:2020-12-16 Issue:2 Volume:34 Page:483-494
ISSN:0893-228X
Container-title:Chemical Research in Toxicology
language:en
Short-container-title:Chem. Res. Toxicol.

Author:

Carfagna Mark A.¹^ORCID,Anderson Jesse²,Eley Christopher³,Fukushima Tamio⁴,Horvath Joseph⁵,Houser William⁵,Larsen Bo⁶,Page Todd¹,Russo Daniel²⁷,Sloan Cheryl⁵,Snyder Kevin²,Thompson Rick⁸,Ullmann Gitte⁶,Whittaker Matthew²

Affiliation:

1. Eli Lilly and Company, Indianapolis, Indiana, United States

2. Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States

3. Pfizer Inc., Groton, Connecticut, United States

4. Shionogi & Co., Ltd., Osaka, Japan

5. Bristol-Myers Squibb, New Brunswick, New Jersey, United States

6. Novo Nordisk, Copenhagen, Denmark

7. Oak Ridge Institute for Science and Education, Oak Ridge, Tennessee, United States

8. Janssen, Spring House, Pennslyvania, United States

Publisher

American Chemical Society (ACS)

Subject

Toxicology,General Medicine

Link

http://pubs.acs.org/doi/pdf/10.1021/acs.chemrestox.0c00317

Reference11 articles.

1. Bjerregaard, T. G. Inadequate requirements to analytical keys may compromise standardized analysis of SEND data - with focus on laboratory data (LB) - Why SEND++ should be considered. Master’s Thesis, University of Copenhagen, Denmark, 2014.

2. Making sense of SEND; the Standard for Exchange of Nonclinical Data

3. Sato, G., Suzuki, M., and Nakajima, M., Qualitative Analysis of Actual SEND Datasets for Trial Design Domains. Poster PP21 2018, https://www.lexjansen.com/phuse-us/2018/pp/PP21_ppt.pdf.

4. Sato, G., Suzuki, M., and Watanabe, K. De-identification and Sharing of Nonclinical CDISC SEND datasets: Basic Idea and Concrete Method: Proposal from JPMA. Presentation at CDISC Japan Interchange July 2019.

5. Introducing the concept of virtual control groups into preclinical toxicology testing

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