Batch-to-batch quality consistency evaluation of botanical drug products using multivariate statistical analysis of the chromatographic fingerprint

AAPS PharmSciTech

Volumn 14, Issue 2, 2013, Pages 802-810

  Xiong, Haoshu ^a   Yu, Lawrence X ^b   Qu, Haibin ^a  

^a ZHEJIANG UNIVERSITY   (China)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

botanical drug products; chromatographic fingerprint; manufacturing process; multivariate statistical analysis; quality consistency

Indexed keywords

BOTANICAL DRUG; DRUG; UNCLASSIFIED DRUG;

ARTICLE; CHEMICAL COMPOSITION; CHINA; CHINESE MEDICINE; CHROMATOGRAPHIC FINGERPRINTING; CHROMATOGRAPHY; DRUG EFFICACY; DRUG INDUSTRY; DRUG QUALITY; DRUG SAFETY; EVALUATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INJECTION; MULTIVARIATE ANALYSIS; PRIORITY JOURNAL; QUALITY CONTROL;

CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG COMBINATIONS; DRUGS, CHINESE HERBAL; FEASIBILITY STUDIES; INJECTIONS; MODELS, STATISTICAL; MULTIVARIATE ANALYSIS; PRINCIPAL COMPONENT ANALYSIS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL;

EID: 84879099629     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-013-9966-9     Document Type: Article

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