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Consideration on critical quality attributes determination of Chinese materia medica preparations / 中草药
Chinese Traditional and Herbal Drugs ; (24): 4008-4012, 2019.
Article in Chinese | WPRIM | ID: wpr-850869
ABSTRACT
In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards.

Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: Chinese Traditional and Herbal Drugs Year: 2019 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: Chinese Traditional and Herbal Drugs Year: 2019 Type: Article