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Focuses and difficulties in clinical study of botanical drugs based on revised guidance for Industry by FDA / 药学学报
Acta Pharmaceutica Sinica ; (12): 505-509, 2017.
Article in Chinese | WPRIM | ID: wpr-779621
ABSTRACT
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.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline Language: Chinese Journal: Acta Pharmaceutica Sinica Year: 2017 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline Language: Chinese Journal: Acta Pharmaceutica Sinica Year: 2017 Type: Article