Analytical method validation for biomarkers as a drug development tool: points to consider-Reference-Cited by-同舟云学术

Analytical method validation for biomarkers as a drug development tool: points to consider

Published:2021-09 Issue:18 Volume:13 Page:1379-1389
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Ohtsu Yoshiaki¹^ORCID,Tanaka Seiji²,Igarashi Harue³,Kakehi Masaaki⁴,Mori Tamiki⁵,Nakamura Takahiro⁶,Ohashi Rui⁷,Shimizu Hiroyuki⁸,Yasuda Yutaka⁹,Okayama Takashige¹⁰,Kakuo Hiroyuki¹⁰,Yokoi Hiroyuki¹¹,Horiuchi Mizuki¹²,Katashima Masataka¹³,Nakamura Ryosuke¹⁴,Saito Kosuke¹⁴,Saito Yoshiro¹⁴^ORCID

Affiliation:

1. Kyowa Kirin Co., Ltd. 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8731, Japan

2. ASKA Pharmaceutical Co., Ltd. Muraoka-Higashi 2-chome, Fujisawa-shi, Kanagawa, 251-8555 Japan

3. GlaxoSmithKline K.K., 1-8-1 Akasaka, Minato-ku, Tokyo, 107-0052, Japan

4. Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa-shi, Kanagawa, 251-8555, Japan

5. LSI Medience Corporation, 13-4 Uchikanda 1-chome, Chiyoda-ku, Tokyo, 101-8517, Japan

6. Shin Nippon Biomedical Laboratories, 2438 Miyanoura, Kagoshima-shi, Kagoshima, 891-1394, Japan

7. Kyowa Kirin, Inc. 212 Carnegie Center, Suite 400, Princeton, NJ 08540, USA

8. Mitsubishi Tanabe Pharma Corporation, 2-26-1 Muraoka-Higashi, Fujisawa-shi, Kanagawa, 251-8555, Japan

9. Toray Research Center, Inc, 10-1 Tebiro 6-chome, Kamakura-shi, Kanagawa, 248-0036, Japan

10. Taiho Pharmaceutical Co., Ltd. 3 Okubo, Tsukuba-shi, Ibaraki, 300-2611, Japan

11. Otsuka Pharmaceutical Co., Ltd. 463-10 Kagasuno, Kawauchi-cho, Tokushima-shi, Tokushima, 771-0192, Japan

12. Sumitomo Dainippon Pharma Co., Ltd. 13-1 Kyobashi 1-Chome, Chuo-ku, Tokyo, 104-8356, Japan

13. Astellas Pharma Inc. 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan

14. National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, 210-9501, Japan

Abstract

Biomarkers are an important drug developmental tool. Assessment of quantitative analytical methods of biomarkers is not included in any regulatory documents in Japan. Use of biomarkers in clinical evaluations and supporting the post-marketing evaluation of drug efficacy and/or adverse reactions requires assessment and full validation of analytical methods for these biomarkers. The Biomarker Analytical Method Validation Study Group is a research group in Japan comprising industry and regulatory experts. Group members discussed and prepared this ‘points to consider document’ covering measurements of endogenous metabolites/peptides/proteins by ligand binding assays and chromatographic methods with or without mass spectrometry. We hope this document contributes to the global harmonization of biomarker assay validation.

Funder

Japan Agency for Medical Research and Development

Publisher

Future Science Ltd

Subject

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

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2021-0173

Reference12 articles.

1. Japan Ministry of Health, Labour and Welfare. Technical Guidance on Development of In Vitro Companion Diagnostics and Corresponding Therapeutic Products, December 26, 2013. https://www.pmda.go.jp/files/000157570.pdf (in Japanese).

2. Japan Ministry of Health, Labour and Welfare. Guideline on Bioanalytical Method Validation in Pharmaceutical Development. July 11, 2013. https://www.pmda.go.jp/files/000206209.pdf

3. Japan Ministry of Health, Labour and Welfare. Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development. April 1, 2014. https://www.pmda.go.jp/files/000206208.pdf

4. Biomarker assay validation for clinical trials: a questionnaire survey to pharmaceutical companies in Japan

5. Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

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