Integrating chemical similarity and bioequivalence: A pilot study on quality consistency evaluation of dispensing granule and traditional decoction of Scutellariae Radix by a totality-of-the-evidence approach

Author:

Liang Dan,Yin Ying-Hao,Miao Lan-Yun,Zheng Xian,Gao Wen,Chen Xiang-Dong,Wei Mei,Chen Sheng-Jun,Li Song,Xin Gui-Zhong,Li Ping,Li Hui-Jun

Funder

National Natural Science Foundation of China

National Key R&D Program of China

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference30 articles.

1. Comparison of effectiveness and safety between granules and decoction of Chinese herbal medicine: a systematic review of randomized clinical trials;Luo;J. Ethnopharmacol.,2012

2. Guidance for Quality Control and Quality Standard of TCM Dispensing Granules (Draft for comment),1950

3. UPLC-PDA-TOFMS based chemical profiling approach to rapidly evaluate chemical consistency between traditional and dispensing granule decoctions of traditional medicine combinatorial formulae;Li;J. Pharm. Biomed. Anal.,2010

4. Traditional Medicine Strategy 2002-2005,2002

5. Guidance for Industry: Botanical Drug Products,2004

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