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Multivariate statistical process control in product quality review assessment - A case study.

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第一作者： M,Kharbach

第一单位： Pharmaceutical and toxicological analysis research team, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, university Mohammed V. Souissi, avenue Med Belarbi El Alaoui, BP 6203, 10000 Rabat, Morocco; Department of analytical chemistry and pharmaceutical technology, CePhaR, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium.

作者： M,Kharbach ^[1] ; Y,Cherrah ^[2] ; Y,Vander Heyden ^[3] ; A,Bouklouze ^[4]

作者单位： Pharmaceutical and toxicological analysis research team, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, university Mohammed V. Souissi, avenue Med Belarbi El Alaoui, BP 6203, 10000 Rabat, Morocco; Department of analytical chemistry and pharmaceutical technology, CePhaR, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium. ^[1] Pharmaceutical and toxicological analysis research team, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, university Mohammed V. Souissi, avenue Med Belarbi El Alaoui, BP 6203, 10000 Rabat, Morocco. ^[2] Department of analytical chemistry and pharmaceutical technology, CePhaR, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium. ^[3] Pharmaceutical and toxicological analysis research team, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, university Mohammed V. Souissi, avenue Med Belarbi El Alaoui, BP 6203, 10000 Rabat, Morocco. Electronic address: a.bouklouze@um5s.net.ma. ^[4]

关键词 Analyse en composante principale Annual product review Hotelling's T(2)Ma?trise statistique du procédé Ma?trise statistique du procédé multivariée Multivariate statistical process control Principal component analysis Revue annuelle produit Statistical process control T(2) de Hotelling

医学主题词色谱法, 高压液相(Chromatography, High Pressure Liquid);制药工业(Drug Industry);摩洛哥(Morocco);多元分析(Multivariate Analysis);药用制剂(Pharmaceutical Preparations);主成分分析(Principal Component Analysis);质量控制(Quality Control)

DOI 10.1016/j.pharma.2017.07.003

PMID 28797469

发布时间 2018-06-18

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