| 从美国 FDA 审评角度探讨新药研发的风险控制 |
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| 引用本文： | 龚兆龙.从美国 FDA 审评角度探讨新药研发的风险控制[J].微生物学杂志,2015(11). |
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| 作者姓名： | 龚兆龙 |
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| 作者单位： | 1. 思路迪医药科技有限公司，北京 100176；2. 美国汉佛莱医药顾问有限公司，马里兰 柏赛斯塔 20817 |
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| 摘 要： | 众所周知，新药研发是一个漫长而艰难的过程，投入大，但成功率低。从项目的选择、分子结构最优化、靶点的选择、体外实
验结果与体内反应的一致性、药物安全性、临床试验设计优化以及对新药研发相关法规的理解、与监管部门的有效沟通等诸方面，探讨
对新药研发风险的把控。
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| 关 键 词： | 新药研发 风险控制 未被满足的临床需求 靶点 临床试验设计 药物安全性 |
Discussion on Risk Management in New Drug Development
from the Perspective of U.S. FDA Review |
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| GONG Zhaolong.Discussion on Risk Management in New Drug Development
from the Perspective of U.S. FDA Review[J].Journal of Microbiology,2015(11). |
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| Authors: | GONG Zhaolong |
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| Institution: | 1. 3D Medicines Inc., Beijing 100176, China; 2. Humphries Pharmaceutical Consulting, LLC, Bethesda 20817, USA |
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| Abstract: | It is well known that the new drug development is a long and arduous process with huge investment and low success rate. From aspects of the
choice of projects, the optimization of molecular structures, the selection of targets, the consistency between in vitro results and in vivo reactions, drug safety,
the optimization of clinical trial design as well as the understanding of the relevant laws and regulations and the effective communication with regulatory
authorities, the risk management in new drug development was discussed. |
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| Keywords: | new drug development risk management unmet clinical needs target clinical trial design drug safety |
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