A new PAT/QbD approach for the determination of blend homogeneity: Combination of on-line NIRS analysis with PC Scores Distance Analysis (PC-SDA)-Reference-Cited by-同舟云学术

A new PAT/QbD approach for the determination of blend homogeneity: Combination of on-line NIRS analysis with PC Scores Distance Analysis (PC-SDA)

Published:2011-05 Issue:1 Volume:78 Page:173-182
ISSN:0939-6411
Container-title:European Journal of Pharmaceutics and Biopharmaceutics
language:en
Short-container-title:European Journal of Pharmaceutics and Biopharmaceutics

Author:

Puchert T.,Holzhauer C.-V.,Menezes J.C.,Lochmann D.,Reich G.

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference49 articles.

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3. Analysis of eighteen antidepressants, four atypical antipsychotics and active metabolites in serum by liquid chromatography: a simple tool for therapeutic drug monitoring;Frahnert;J. Chromatogr. B,2003

4. Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part II. Qualitative approaches to blend evaluation;Sekulic;J. Pharm. Biomed. Anal.,1998

5. US Department of Health and Human Services: Food and Drug Administration, Guidance: PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, 2004.

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