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Focuses and difficulties in clinical study of botanical drugs based on revised guidance for Industry by FDA
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Xiao-dong ZHANG1, Long CHENG2, Geng LI3, Xiao-bo SUN2, *
Acta Pharmaceutica Sinica | 2017, 52(4) : 505 - 509
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Acta Pharmaceutica Sinica | 2017, 52(4): 505-509
• PROFESSIONALS FORUM •
Focuses and difficulties in clinical study of botanical drugs based on revised guidance for Industry by FDA
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Xiao-dong ZHANG1, Long CHENG2, Geng LI3, Xiao-bo SUN2, *
Affiliations
  • 1. Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China
  • 2. Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China
  • 3. China-Japan Friendship Hospital, Beijing 100029, China
Published: 2017-04-12 doi: 10.16438/j.0513-4870.2016-0769
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This paper was prepared to analyze and discuss the main content of the Botanical Drug Development Guidance for Industry by United States FDA's (the draft version of the 2015), especially focused on the guidelines for clinical research (mainly in late-stage clinical studies) recommendations and requirements sectiones. The key and difficult issues in the late clinic study were analyzed and discussed, and a series of countermeasures were proposed in this paper. At the same time, combined with the case of approved botanical drug products, analysis of the guidelines for the development of plant drug regulations, the enlightenment were presented in the last part, to guide the research and development of traditional Chinese medicine and the internationalization of Chinese medicine.

Botanical Drug Development Guidance for Industry  /  clinical study  /  efficacy evaluation  /  safety evaluation
Xiao-dong ZHANG, Long CHENG, Geng LI, Xiao-bo SUN. Focuses and difficulties in clinical study of botanical drugs based on revised guidance for Industry by FDA[J]. Acta Pharmaceutica Sinica, 2017 , 52 (4) : 505 -509 . DOI: 10.16438/j.0513-4870.2016-0769
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Article Info
doi: 10.16438/j.0513-4870.2016-0769
  • Receive Date：2016-08-04
  • Online Date：2026-01-14
  • Published：2017-04-12
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History
  • Received：2016-08-04
  • Revised：2016-09-17
Affiliations
    1. Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China
    2. Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China
    3. China-Japan Friendship Hospital, Beijing 100029, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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