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| Management and experience of phase I clinical trial ward |
| Hits 2257 Download times 2095 Received:July 02, 2016 |
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| DOI
10.11656/j.issn.1672-1519.2016.12.09 |
| Key Words
phase I clinical trial;ward;management |
| Author Name | Affiliation | E-mail | | MI Bo | Second Affiliated Hospital of TianJin University of Traditional Chinese Medicine, Tianjin 300150, China | | | LI Yan-fen | Second Affiliated Hospital of TianJin University of Traditional Chinese Medicine, Tianjin 300150, China | | | SUN Jin-xia | Second Affiliated Hospital of TianJin University of Traditional Chinese Medicine, Tianjin 300150, China | | | LI Mei-feng | Second Affiliated Hospital of TianJin University of Traditional Chinese Medicine, Tianjin 300150, China | | | WANG Bao-he | Second Affiliated Hospital of TianJin University of Traditional Chinese Medicine, Tianjin 300150, China | | | HUANF Yu-hong | Second Affiliated Hospital of TianJin University of Traditional Chinese Medicine, Tianjin 300150, China | hyh101@126.com |
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| Abstract
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| Phase I clinical trial ward was the place where phase I clinical trials of new drugs were conducted.The procedures in trials must be strictly implemented by Good Clinical Practice (GCP).Phase I clinical trials are the initial stage of new drugs in human,mainly for preliminary clinical pharmacology and the evaluation of human safety.Phase I clinical trial ward has been established in The Second Affiliated Hospital of TianJin University of Traditional Chinese Medicine since 2004,and the management was gradually improving in the work.We updates standard operating procedures (SOP) to ensure phase I clinical trials be conducted standardized,rigorous,and safe.This article will outline the management and work experience of phase I clinical trial ward in our hospital to readers,and promote common progress. |
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