Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, 210-9501, Japan.
Shin Nippon Biomedical Laboratories, Ltd, Kagoshima, 891-1394, Japan.
Bioanalysis. 2023 Sep;15(17):1069-1081. doi: 10.4155/bio-2023-0071. Epub 2023 Aug 16.
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.
核酸 (NA) 标志物在药物开发中起着关键作用。然而，用于评估特定于 NA 标志物的定量方法的全球监管指南有限。分析方法的验证对于在药物疗效和不良反应的临床和上市后评估中使用生物标志物至关重要。鉴于定量聚合酶链反应 (qPCR) 和逆转录 qPCR (RT-qPCR) 方法是 NA 生物标志物定量的金标准，日本的生物标志物分析方法验证研究小组已经讨论了考虑因素，并为基于 qPCR 和 RT-qPCR 的内源性 NA 生物标志物分析方法的开发和验证提出了建议作为药物开发工具。本白皮书旨在为全球范围内的 NA 生物标志物分析验证的标准化做出贡献。
