Proposed selection strategy of surrogate matrix to quantify endogenous substances by Japan Bioanalysis Forum DG2015-15-Reference-Cited by-同舟云学术

Proposed selection strategy of surrogate matrix to quantify endogenous substances by Japan Bioanalysis Forum DG2015-15

Published:2018-09-01 Issue:17 Volume:10 Page:1349-1360
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Wakamatsu Akira¹,Ochiai Shoko²,Suzuki Eiko³,Yokota Yoshinobu⁴,Ochiai Midori⁵,Kotani Yosuke⁶,Sasahara Satomi⁷,Nakanaga Keita⁸,Hashimoto Yuki⁹,Ueno Satoko¹⁰,Kato Nozomu¹¹,Kawada Satoshi¹²,Hayakawa Jun¹³,Shimada Eiichi¹⁴,Horita Shinya¹⁵,Sakai Kazuaki¹⁶

Affiliation:

1. Bioanalysis, Immunogenicity & Biomarkers, Pre-Clinical Development Department, GlaxoSmithKline K.K. Akasaka Intersity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan

2. Preclinical Research Unit, Drug Research Division, Sumitomo Dainippon Pharma Co., Ltd, 3-1-98 Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan

3. Drug Metabolism and Pharmacokinetics Research Laboratories, Daiichi Sankyo Co., Ltd, 1-2-58, Hiramachi, Shinagawa-ku, Tokyo 140-8710, Japan

4. Ligand Binding, Analytical Biology, SNBL USA, Ltd, 6605 Merrill Creek Parkway, Everett, WA 98203, USA

5. Development Management Department, Research & Development Division, Towa Pharmaceutical Co., Ltd, 2-5-15, Hiyoshi-cho, Moriguchi, Osaka 570-0081, Japan

6. Research Unit 2, Pharmacokinetics and Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd, 16-1, Minami-Akasaka, Kainan, Wakayama 642-0017, Japan

7. Medicines Evaluation Team, Scientific Research and Business Development Department, Towa Pharmaceutical Co., Ltd, Kyoto Research Park KISTIC #202, 134, Chudoji Minami-machi, Shimogyo-ku, Kyoto, Kyoto 600-8813, Japan

8. Toxicology and Pharmacokinetics Laboratories, Pharmaceutical Research Laboratories, Toray Industries, Inc., 10-1, Tebiro 6-chome, Kamakura, Kanagawa 248-8555, Japan

9. Bioanalysis Group, Osaka Laboratory, Technical Solution Headquarters, Sumika Chemical Analysis Service, Ltd, 1-135, Kasugade-Naka 3-chome, Konohana-ku, Osaka 554-0022, Japan

10. Advanced Analytical Sciences Group, Fundamental Technology Labs., Institute For Innovation, Ajinomoto Co., Inc. 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-8681, Japan

11. Discovery Technology Laboratories, Sohyaku Innovative Research Division, Mitsubishi Tanabe Pharma Corporation, 2-2-50, Kawagihi, Toda-shi, Saitama 335-8505, Japan

12. Research Unit 1, Pharmacokinetics and Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd, 16-1, Minami-Akasaka, Kainan, Wakayama 642-0017, Japan

13. Biomarker R&D Department, Shionogi & Co., Ltd, 1-1, Futaba-cho 3-chome Toyonaka, Osaka 561-0825, Japan

14. Pharmacokinetic Research Laboratories, Ono Pharmaceutical Co., Ltd, 17-2 Wadai Tsukuba-shi, Ibaraki 300-4247, Japan

15. Pharamacokinetics Research Laboratories, Translational Research Unit, R&D Division, Kyowa Hakko Kirin Co., Ltd, 1188, Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731, Japan

16. DMPK Research Department, Teijin Institute for Bio-medical Research, Teijin Pharma Ltd 4-3-2 Asahigaoka, Hino, Tokyo 191-8512, Japan

Abstract

It is important to select an appropriate surrogate matrix for preparing calibration standards and quality control samples while quantitatively assaying for endogenous substances, because a blank matrix that does not contain the endogenous substance cannot be derived from the species from which the target study samples are collected. This is because the assay results might be affected, depending on the characteristics of the analyte in the surrogate matrix. Our discussion group that participated in the Japan Bioanalysis Forum discussed the recommended selection strategies, focusing on large and small molecules in ligand binding assays and LC–MS, respectively. We established an efficient selection strategy for a surrogate matrix, with simple compositions as the first candidates stated in this article.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2018-0105

Reference8 articles.

1. Quantitative determination of endogenous compounds in biological samples using chromatographic techniques

2. Generic approach to validation of small-molecule LC–MS/MS biomarker assays

3. MHLW. Guideline on Bioanalytical Method Validation in Pharmaceutical Development. PFSB/ELD Notification No. 0711–1 dated July 11 (2013). http://www.pmda.go.jp/files/000206209.pdf.

4. MHLW. Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development. PFSB/ELD Notification No. 0401–1 dated April 11 (2013). http://www.pmda.go.jp/files/000206208.pdf.

5. MHLW. Questions and Answers (Q&A) for the Guideline on Bioanalytical Method Validation in Pharmaceutical Development. Office Communication dated July 11 (2013). http://www.pmda.go.jp/files/000206209.pdf.

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