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Conference Report ——Training Course of Population Pharmacokinetics & Phase I PK/PD Clinical Trial
2019-02-18Return>>


Group Picture of Population Pharmacokinetics & Phase I PK/PD Clinical Trial Training Course


From December 26-27, 2018, the population pharmacokinetics (pop-PK) and Phase I of PK/PD clinical trial training courses were successfully completed in Shanghai thanks to the strong support from the Pharmaceutical Clinical Research Committee of Shanghai Pharmaceutical Association, dMed Biopharmaceutical (Shanghai) Co., Ltd., and the Bio-Industry Association of Shanghai Pudong New Area.



Professor Zhao Naiqing, Vice President of Biostatistics of dMed, Doctoral Supervisor of Department of Biostatistics, Fudan University, hosted the ceremony


Research & development (R&D) of new drugs is evolving rapidly in China. In light of this growth, it is critically important to bridge the study results in Western populations with a sample size of clinical trial data in Chinese populations, explain the differences in pharmacokinetics between these populations, and guide the clinical application of new drugs. This training course is designed to help hospital, pharmaceutical companies and pharmaceutical R&D institutions apply new technologies in pharmacokinetics, biomarkers, and statistics for to accelerate the process of new drug R&D. dMed Biopharmaceutical (Shanghai) Co., Ltd. collaborated with several leading institutes and pharmaceutical companies by inviting distinguished experts and scholars in the field of pharmacology and statistics to lead the training sessions.



Professor Zhang Jing, Deputy Director of Pharmaceutical Clinical Trial Institution and Director of Phase I Clinical Research Department of Huashan Hospital Affiliated to Fudan University


The following topics were covered in training:

  • Research methods and clinical implementation summaries
  • Application and case sharing in clinical research of new drugs
  • Software integration
  • Data set construction
  • Model establishment and validation
  • Case analysis of clinical drug delivery schemes guided by PK/PD research
  • Experimental simulation of population PK/PD for drug development in children and dosage selection of targeted drugs
  • Statistical study design in consistency evaluation of highly variable drugs
  • Early clinical pharmacology design driven by PK/PD
  • Clinical pharmacokinetic design of biosimilar studies


Professor Wei Minji, Director of Pharmacokinetics Research Department, Institute of Clinical Pharmacology, Peking University


Dr. Shi Jun, Senior Director of Clinical Pharmacology, Roche R&D (China) Co., Ltd.


Training instructors elaborately designed the courses, providing a wealth of case studies and opinions. The experts also shared details about the application of pop-PK software, programming methodology as well as illustrating the codes.



Dr. Zheng Shirui, Senior Manager of Clinical Pharmacology, Xinda Biopharmaceutical (Suzhou) Co., Ltd.


Dr. Yang Xiaodong, Director of Clinical Pharmacology Department of dMed


Training participants greatly valued the opportunity to discuss their work, scientific topics with experts in good depth.


Although the workshop only lasted 2 days, trainees from clinical pharmacology、medicine、biostatistics and other related specialties in hospitals and drug R&D enterprises expressed enthusiasm that it broadened their horizons in the industry. The training also provided an opportunity for them to network with each other and the experts, setting the foundation for future cooperation. They are eagerly looking forward to the next activity.


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