Course Info: Dose Selection and Optimization in Drug Development and in Real-world Regimens

How to inform dose selection with existing data?
How to make dose escalation schedule?
How to act at key decision points?
Why is there gap between dose regimens in design and in the real world?
Regulatory and clinical experts will lecture from their respective perspectives on dose selection in four quintessential cases.

[Course Description]
    Directly related to the effectiveness and safety of drugs, dose selection is a constant theme that runs through the entire process from bench to bedside. To improve dose selection and optimization in drug development, this course combines perspectives of regulatory experts and clinical ones, reviews considerations in drug development and in clinic, and analyzes gaps between dose regimens in design and in the real world.

[Case Study of Four Representative Drugs]
­    Nivolumab (tumor immunotherapy drug): Dose Selection and Optimization in Drug Development vs. in Real-world Regimens
­    Everolimus (immunosuppressive agent): Dose Selection and Optimization in Drug Development vs. in Real-world Regimens
­    Edoxaban (cardiovascular drug): Dose Selection and Optimization in Drug Development vs. in Real-world Regimens
­    Indacaterol (respiratory disease drug): Dose Selection and Optimization in Drug Development vs. in Real-world Regimens

[Core Lecturers]
(In alphabetical order)
­    Prof. CHEN Yahong, Chief of Respiratory and Critical Care Medicine, Peking University Third Hospital
­    Prof. LI Haiyan, Chief of Cardiology and Director of Drug Clinical Trial Center, Peking University Third Hospital; adjunct professor, the PUCRI
­    Prof. LIANG Li, Chief of Cancer Chemotherapy and Radiation Department, Peking University Third Hospital
­    Prof. WANG Xianghui, Chief of Urosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
­    Dr. WANG Yaning, Director of the Division of Pharmacometrics, Office of Clinical Pharmacology, the United States Food and Drug Administration; visiting professor, the PUCRI

[Target Audience]
­    Clinicians
­    Corporate drug R&D personnel
­    Drug reviewers

[Contact Person]
SUN Wan
Tel/Wechat: 13810653872
E-mail: sunwan_pucri@bjmu.edu.cn