【摘 要】
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In the recent years the more and more innovative drugs have been developed in China.It changes the mode of early phase clinical trials in China.To accommoda
【机 构】
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PhaseⅠUnit,PekingUnionMedicalCollegeHospitalBeijing100730,China
【出 处】
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2015年第一届药代动力学朝阳论坛
论文部分内容阅读
In the recent years the more and more innovative drugs have been developed in China.It changes the mode of early phase clinical trials in China.To accommodate these changes and speed up new drug development, CFDA published two new guidelines focusing on phase Ⅰ trials in the end of 2011.Since then, the profound impact of these two guidelines on the management of Phase Ⅰ facilities in China has been revealed.Some phase Ⅰ unit have set up a research platform which focuses on first in human (FIH) trials.Based on the platform, the strategy of model-based drug development (MBDD) is applied in clinical development of new drug.Quicker response from lab to guide dose selection is becoming possible since the close collaboration between clinical team and bioassay lab in the unit.That makes clinical trials safer and more efficient.In the future, the conduction of phase Ⅰ studies in China will reach international standards further.Based on the PK and PK/PD from phase Ⅰ studies, modeling/simulation and the population approach will be applied more in phase Ⅱ and phase Ⅲ trial design in the future.Finally, model based clinical study design will be developed in China.
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