Development and validation of qPCR methods for nucleic acid biomarkers as a drug development tool: points to consider-Reference-Cited by-同舟云学术

Development and validation of qPCR methods for nucleic acid biomarkers as a drug development tool: points to consider

Published:2023-09 Issue:17 Volume:15 Page:1069-1081
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Sun Yuchen¹^ORCID,Nakamura Takahiro²,Ohtsu Yoshiaki³^ORCID,Kakehi Masaaki⁴,Danno Noriyuki⁵,Shimizu Hiroyuki⁶,Tanaka Yoichi¹^ORCID,Serelli-Lee Victoria⁷⁸^ORCID,Tanaka Seiji⁹,Okayama Takashige¹⁰,Suda Yusuke¹¹,Moriya Yuu⁴,Hanada Takeshi¹²,Saito Yoshiro¹^ORCID

Affiliation:

1. Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, 210-9501, Japan

2. Shin Nippon Biomedical Laboratories, Ltd, Kagoshima, 891-1394, Japan

3. Kyowa Kirin Co., Ltd, Shizuoka, 411-8731, Japan

4. Takeda Pharmaceutical Company, Limited, Kanagawa, 251-8555, Japan

5. CMIC Pharma Science Co., Ltd, Yamanashi, 408-0044, Japan

6. Mitsubishi Tanabe Pharma Corporation, Kanagawa, 251-8555, Japan

7. Eli Lilly Japan KK, Hyogo, 651-0086, Japan

8. Clinical evaluation sub-committee, Medicinal Evaluation Committee, Japan Pharmaceuticals Manufacturers Association, Tokyo, 103-0023, Japan

9. ASKA Pharmaceutical Co., Ltd, Kanagawa, 251-8555, Japan

10. Taiho Pharmaceutical Co., Ltd., Ibaraki, 300-2611, Japan

11. Nippon Shinyaku Co., Ltd, Kyoto, 601-8550, Japan

12. Daiichi Sankyo Co., Ltd, Tokyo, 140-8710, Japan

Abstract

Nucleic acid (NA) biomarkers play critical roles in drug development. However, the global regulatory guidelines for assessing quantification methods specific to NA biomarkers are limited. The validation of analytical methods is crucial for the use of biomarkers in clinical and post-marketing evaluations of drug efficacy and adverse reactions. Given that quantitative polymerase chain reaction (qPCR) and reverse transcription qPCR (RT-qPCR) methods are the gold standards for the quantification of NA biomarkers, the Biomarker Analytical Method Validation Study Group in Japan has discussed considerations and made recommendations for the development and validation of qPCR- and RT-qPCR-based analytical methods for endogenous NA biomarkers as drug development tools. This white paper aims to contribute to the global harmonization of NA 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-2023-0071

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