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1958年-湖北省医药工业研究所组建药理研究室。
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2000年-在原有药理室的基础上成立药理毒理实验中心,深入开展新药的毒理学研究和评价工作
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2002年-湖北省医药工业研究院成立药物安全性评价中心(HCSED),并得到湖北省科技厅的大 |
力支持,“中心”按 |
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“药物非临床研究质量管理规范”(GLP)进行管理运行。
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2004年-通过湖北省科技厅专项验收,批准成立湖北省药物安全性评价中心。年底通过国家食品 |
药品监督管理局的 |
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GLP认证检查。
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2005年-获国家食品药品监督管理局GLP认证检查批准公告(国食药监安[2005]28号)。 |
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1958 – Pharmacology laboratory was established in Hubei Pharmaceutical Industry Res
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earch Institute. |
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2000 – Pharmacology and toxicology experiment center was established based on the |
former pharmacology |
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laboratory. It assumes toxicology studies and evaluations of new drugs.
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2002 – With the effective support of Hubei Provincial Science & Technology Departme |
nt the center |
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for safety evaluation of drugs was founded in our institute. The center was organize |
d and managed |
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according to the Good Laboratory Practice(GLP)standards.
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2004 – The center passed the examination of Hubei Provincial Science & Technology D |
epartment, and |
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was approved to be Hubei Center for Safety Evaluation of Drugs(HCSED). The HCSED a |
cquired the GLP |
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certificate of SFDA in late 2004.
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2005 – The bulletin about the validation of GLP by SFDA was published. |
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