北京大学治疗药物监测和临床毒理中心（TDMCT，以下简称“中心”）成立于2002年，为我国高校首个系统开展TDMCT医教研工作的中心，2009年通过ISO/IEC 17025检测实验室认可，中心经过多年的发展，已成为集“科研-服务-转化”于一体的一流专业学术机构。中心设在北京大学第三医院。

翟所迪教授（北京大学第三医院）担任中心第一、二届主任，王丽教授（北京大学第一医院）任中心副主任。2022年，中心及学术委员换届，由赵立波教授（北京大学第三医院）担任第三届中心主任，张相林教授（中日友好医院）担任第三届学术委员会主任，赵荣生教授（北京大学第三医院）担任第三届学术委员会执行主任。中心聘请国内TDM领域一流专家学者担任专家委员会/学术委员会委员。

TDMCT中心充分整合北京大学的校内资源，构建先进的治疗药物监测模式，开展临床毒理研究，培养TDMCT专业人才，为患者提供个体化医疗服务。目前，中心在指南制定、精准药物治疗、医药协同创新等方面形成了显著的学科优势。

一．制订指南与规范，促进个体化药物治疗

中心基于国际循证药学方法，牵头制订5部治疗药物监测指南，参与制订多部指南。其中，《万古霉素治疗药物监测指南》和《伏立康唑个体化用药指南》是由北京大学第三医院药剂科翟所迪教授牵头、由药师主导制订、中国大陆被美国国立指南数据库（NGC）收录的第一和第二部指南，荣获中国药学会科学技术奖三等奖。《中国大剂量甲氨蝶呤循证用药指南》由北京大学第三医院药剂科赵荣生教授牵头制定，荣登2021年度中国指南STAR评级榜首，代表着目前国内个体化给药临床实践指南制订的最高水平。

    二．多学科交叉融合，构建精准药物治疗体系

中心基于液质联用为基础的现代分析技术开展药物/小分子生物标志物检测和药物相关基因检测研究工作，推进多组学研究发展，建立了7大类60多种药物及150多种内源性代谢物/生物标志物的定量分析方法，并与临床药师、临床医师密切沟通与合作，及时将研究成果用于临床实践。中心开发的万古霉素个体化给药公益平台——PharmVan上线以来，已经服务患者11600例次，形成了研究-实践一体化的精准药物治疗体系，切实提升临床用药和中毒解救水平。

    三．医药协同创新，推进TDM研究转化

中心以临床需求为导向，开展医药协同创新研究，截止2022年已承担国家863课题1项、国家重大新药创制专项子课题10余项、国家自然基金课题17项、北京市科委课题5项，发表SCI及中文核心期刊论文300余篇。上述课题和成果的落地，有利地促进了TDMCT中心的持续发展。

过往皆序章，未来皆可盼，唯有更勤勉，方可不负望。北京大学治疗药物监测和临床毒理中心着眼精准药物治疗，力推多组学等技术在个体化医学中的应用和发展，力争在行业内起到引领作用。

机构负责人：赵荣生、赵立波

联系人：张现化、许嘉旻

邮箱：PKU_TDMCT@163.com

电话：010-82266673

地址：北京市海淀区花园北路49号北京大学第三医院药学楼（邮编100191）

 

Therapeutic Drug Monitoring and Clinical Toxicology Center of Peking University

Peking University Therapeutic Drug Monitoring and Clinical Toxicology Center (TDMCT Center), the first center to systematically prompt clinical practice, medical education and research work on TDMCT in China's universities, was established in 2002 and passed “General requirements for the competence of testing and calibration laboratories”(ISO/IEC 17025) in 2009. TDMCT Center has now become a top-notch professional academic institution integrating "research-service-transformation" after years of development. The center is located in Peking University Third Hospital.

Prof. Shodi Zhai (Peking University Third Hospital) served as the first and second director of the Center, and Prof. Li Wang (Peking University First Hospital) served as the deputy director of the Center. After a new round of election in 2022, Prof. Libo Zhao (Peking University Third Hospital) has become the third director of the Center, Prof. Xianglin Zhang (China-Japan Friendship Hospital) is the director of the third academic committee, and Prof. Rongsheng Zhao (Peking University Third Hospital)  is the executive director of the third academic committee. The members of the expert committee/academic committee are composed of the foremost experts in the field of TDMCT in China.

The center is committed to fully integrating the resources of Peking University, building an advanced therapeutic drug monitoring model, conducting clinical toxicology research, training TDMCT professionals, and providing individualized medical services to patients. At present, the Center has formed significant disciplinary advantages in guideline development, interdisciplinarity, and collaborative innovation in medical and pharmaceutical research.

I. Developing guidelines and norms to promote individualized drug therapy

Based on international evidence-based medicine methods, the TDMCT Center took the lead in formulating 5 therapeutic drug monitoring guidelines. Among them, “Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic drug monitoring, Chinese Pharmacological Society” and “Individualized medication of voriconazole: a practice guideline of the Division of Therapeutic drug monitoring, Chinese Pharmacological Society” are the first and second Chinese (mainland China) national clinical practice guideline formulated by pharmacists and included in National Guideline Clearinghouse (NGC) respectively, which won the third prize of Science and Technology Award of Chinese Pharmaceutical Society. “Medication therapy of high-dose methotrexate: An evidence-based practice guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society” topped the 2021 China Guideline STAR rating, representing the highest level of clinical practice guidelines for individualized drug administration in China.

II. Carrying out multidisciplinary intersection to build a precision medication system

We have carried out research on drugs, small molecule biomarker detection, and genome sequencing with the aid of modern analytical techniques based on liquid chromatography-mass spectrometry. We promoted the development of multi-omics research and established quantitative analysis methods for more than 60 drugs and more than 150 endogenous metabolites/biomarkers in 7 categories. The achievements were applied to clinical practice timely based on the close collaboration with clinical pharmacists and clinicians. Since its launch, PharmVan, a public welfare platform for individualized vancomycin administration developed by the center, has served 11,600 cases of patients, forming a precision medication system integrating research and practice, and effectively improving the level of clinical medication and poisoning rescue.

III. Promoting collaborative innovation in medical and pharmaceutical research to achieve the transformation of TDMCT innovative research

Oriented by clinical needs, we conducted a serial of interdisciplinary research in the field of clinical medicine and pharmacy. As of 2022, we have undertaken one National 863 project, more than 10 National Major New Drug Creation sub-projects, 17 National Natural Science Foundation projects, and 5 Beijing Municipal Science and Technology Commission projects, published more than 300 papers in SCI and Chinese core journals. The implementation of the above-mentioned topics and achievements has favorably promoted the sustainable development of TDMCT Center.

All the past is the prelude, all the future can be expected. Only through more diligence can we live up to our expectations. Focusing on precision medicine treatment, we will promote the application and development of multi-omics technology in personalized medicine, and strive to play a leading role in the area of precision medicine based on the TDMCT.

Director：Rongsheng Zhao, Libo Zhao

Contact：Xianhua Zhang, Jiamin Xu

E-mail：PKU_TDMCT@163.com

Tel：010-82266673

Address: Department of Pharmacy, 49 North Garden Rd., Haidian District Beijing, P.R.China

Postcode：100191