中药新药药效学试验设计的关注要点与思考(4)
[参考文献]
[1] 黄芳华. 抗糖尿病中药新药临床前有效性评价与思考[J].中国中药杂志，2008，33(1)：95.
[2] 黄芳华，朱飞鹏. 抗肿瘤中药药效学研究与评价探讨[J].中国药学杂志，2010，45(22)：1773.
[3] 中华医学会骨质疏松和骨矿盐疾病疾病分会. 原发性骨质疏松症诊疗指南(2011)[J].中华骨质疏松和骨矿盐疾病杂志，2011，4(1)：1.
[4] 中华中医药学会. 慢性胃炎诊疗指南[J].中国中医药现代远程教育，2011，9(10)：123.
[5] 中华医学会消化病学分会. 中国慢性胃炎共识意见[J].现代消化及介入诊疗，2007，12(1)：55.
Concern points and considerations for pharmacodynamic study design of
new traditional Chinese medicines
HUANG Fang-hua
(Center for Drug Evaluation， State Food and Drug Administration， Beijing 100038， China)
[Abstact] Pharmacodynamic(PD) studies play an important role in research and development of new traditonal Chinese medicines(TCMs). Phamacologic and toxicologic studies that aim to research druggability can provide supporting data for the clinical trials and reduce the risk of clinical trials. In recent years， PD studies in TCMs are developing and progressing， but there are still some problems affecting the value of PD studies in the development of new TCMs. The value of PD studies depends on scientific and rational study design. This article summaries some defects in PD study design of new TCMs that are common in the application data， including defects in study type， testing targets， dosing， duration of administration， control group， testing time.This article also discusses some points of concern and specific requirements for PD study design of new TCMs.
[Key words] new traditional Chinese medicine； pharmacodynamic； study design
doi：10.4268/cjcmm20140637, http://www.100md.com
[1] 黄芳华. 抗糖尿病中药新药临床前有效性评价与思考[J].中国中药杂志，2008，33(1)：95.
[2] 黄芳华，朱飞鹏. 抗肿瘤中药药效学研究与评价探讨[J].中国药学杂志，2010，45(22)：1773.
[3] 中华医学会骨质疏松和骨矿盐疾病疾病分会. 原发性骨质疏松症诊疗指南(2011)[J].中华骨质疏松和骨矿盐疾病杂志，2011，4(1)：1.
[4] 中华中医药学会. 慢性胃炎诊疗指南[J].中国中医药现代远程教育，2011，9(10)：123.
[5] 中华医学会消化病学分会. 中国慢性胃炎共识意见[J].现代消化及介入诊疗，2007，12(1)：55.
Concern points and considerations for pharmacodynamic study design of
new traditional Chinese medicines
HUANG Fang-hua
(Center for Drug Evaluation， State Food and Drug Administration， Beijing 100038， China)
[Abstact] Pharmacodynamic(PD) studies play an important role in research and development of new traditonal Chinese medicines(TCMs). Phamacologic and toxicologic studies that aim to research druggability can provide supporting data for the clinical trials and reduce the risk of clinical trials. In recent years， PD studies in TCMs are developing and progressing， but there are still some problems affecting the value of PD studies in the development of new TCMs. The value of PD studies depends on scientific and rational study design. This article summaries some defects in PD study design of new TCMs that are common in the application data， including defects in study type， testing targets， dosing， duration of administration， control group， testing time.This article also discusses some points of concern and specific requirements for PD study design of new TCMs.
[Key words] new traditional Chinese medicine； pharmacodynamic； study design
doi：10.4268/cjcmm20140637, http://www.100md.com