Mochizuki Ayumi, Ieki Katsunori, Kamimori Hiroshi, Nagao Akemi, Nakai Keiko, Nakayama Akira, Nanba Eitaro
Office of Clinical Pharmacology, Department of Clinical Management, Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan.
Pharmacokinetics & Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd., 16-1 Minamiakasaka, Kainan, Wakayama 642-0017, Japan.
Bioanalysis. 2018 Apr 1;10(8):577-586. doi: 10.4155/bio-2017-0226. Epub 2018 Apr 10.
The guidance and several guidelines on bioanalytical method validation, which were issued by the US FDA, EMA and Ministry of Health, Labour and Welfare, list the 'full' validation parameters; however, none of these provide any details for 'partial' validation. Japan Bioanalysis Forum approved a total of three annual discussion groups from 2012 to 2014. In the discussion groups, members from pharmaceutical companies and contract research organizations discussed the details of partial validation from a risk assessment viewpoint based on surveys focusing on bioanalysis of small molecules using LC-MS/MS in Japan. This manuscript presents perspectives and recommendations for most conceivable changes that can be made to full and partial validations by members of the discussion groups based on their experiences and discussions at the Japan Bioanalysis Forum Symposium.
美国食品药品监督管理局（US FDA）、欧洲药品管理局（EMA）以及日本厚生劳动省发布的指南和多项生物分析方法验证指南列出了“全面”验证参数；然而，这些指南均未提供“部分”验证的任何详细信息。日本生物分析论坛在2012年至2014年期间共批准了三个年度讨论小组。在这些讨论小组中，来自制药公司和合同研究组织的成员基于对日本使用液相色谱-串联质谱法（LC-MS/MS）进行小分子生物分析的调查，从风险评估的角度讨论了部分验证的细节。本手稿基于讨论小组成员在日本生物分析论坛研讨会上的经验和讨论，提出了对全面验证和部分验证最可能做出的改变的观点和建议。
