Interlaboratory Evaluation of LC–MS-Based Biomarker Assays-Reference-Cited by-同舟云学术

Interlaboratory Evaluation of LC–MS-Based Biomarker Assays

Published:2024-03 Issue:6 Volume:16 Page:389-402
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Saito Kosuke¹,Goda Ryoya²,Arai Koji³,Asahina Kota⁴,Kawabata Mitsuhiko⁵,Uchiyama Hitoshi⁶^ORCID,Andou Tomohiro⁷,Shimizu Hisao⁸^ORCID,Takahara Kentaro⁹,Kakehi Masaaki⁸,Yamauchi Saki⁴,Nitta Shin-ichiro³,Suga Takahiro²,Fujita Hisashi⁸,Ishikawa Rika¹,Saito Yoshiro¹

Affiliation:

1. National Institute of Health Sciences, Kanagawa, Japan

2. Daiichi Sankyo Company Ltd, Tokyo, Japan

3. LSI Medience Corporation, Tokyo, Japan

4. Japan Tobacco, Inc., Osaka, Japan

5. Shin Nippon Biomedical Laboratories Ltd, Tokyo, Japan

6. Towa Pharmaceutical Co. Ltd, Osaka, Japan

7. Axcelead Drug Discovery Partners, Inc., Kanagawa, Japan

8. Takeda Pharmaceutical Company Ltd, Kanagawa, Japan

9. Thermo Fisher Scientific K.K., Tokyo, Japan

Funder

Japan Agency for Medical Research and Development

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.4155/bio-2023-0173

Reference38 articles.

1. FDA-NIH Biomarker Working Group . Biomarkers endpoints and other tools (BEST) resource (2016). www.ncbi.nlm.nih.gov/books/NBK338448/

2. Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine

3. Biomarkers in early-phase trials: fundamental issues

4. Bioanalytical Method Validation Guidance for Industry. US FDA, MD, USA (2018).

5. Critical Path Institute . Points to Consider: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices. Biomarker Assay Collaborative Evidentiary Considerations Writing Group (2019).