发布时间:
2018
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12
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11
点击次数:
0
Positions：
Director of Phase I Clinical Trial Center
Company：
PKUCare Luzhong Hospital
个人简介：
Dr. Hou has been engaged in the reserch work in clinical pharmacology and clinical trials of new drugs for nearly 30 years. In 1989, she served as the director of Phase I and Phase II clinical trial wards at the Institute of Clinical Pharmacology in Beijing Medical University. In 2002, she went to the United States as a postdoctoral fellow to conduct cardiovascular clinical pharmacology research and completed a number of clinical evaluations of drug cardiovascular toxicity. In 2008, she was appointed as the director of Phase I Clinical Trial Center of Teda International Cardiovascular Hospital and the director of Early Clinical Trial of FMD. Since 2014, Dr. Hou was appointed as the CMO of eStartMed Technology Co., Ltd. Up to date, she has lead and accomplished more than 100 Phase I new drug clinical trials, bioequivalence trials and dozens of FIH. All ccomplished trials include: anti-tumor drugs apatinib, pyrrolidine and 19K, etc., diabetes drugs PEX-168 , GLP-1, DDPIV-inhibitor , GKA, etc., and bioequivalence trials (BE) of imatinib, pramipexole, celecoxib, lenalidomide, etc. In 2013 Dr. Hou’s group completed the first domestic TQT clinical trial (Morpholinamide) according to international standards, and multiple IQT (or CQT) studies. Since 2009, Dr. Hou has participated in the drafting of many guidelines such as CFDA “Guidelines for the Management of Phase I Clinical Trials of Drugs” and “Regulations for Laboratory Management in Analysis of Biological Samples in Drug Clinical Trials”，Issue in December 2011.