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Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

Botanical drug products have batch-to-batch quality variability due to botanical raw materials and the current manufacturing process. The rational evaluation and control of product quality consistency are essential to ensure the efficacy and safety. Chromatographic fingerprinting is an important and...

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Détails bibliographiques
Auteurs principaux: Xiong, Haoshu, Yu, Lawrence X., Qu, Haibin
Format: Artigo
Langue:Inglês
Publié: Springer US 2013
Sujets:
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC3665986/
https://ncbi.nlm.nih.gov/pubmed/23636818
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-013-9966-9
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