Development of a NIR-based blend uniformity method for a drug product containing multiple structurally similar actives by using the quality by design principles

Author:

Lin Yiqing,Li Weiyong,Xu Jin,Boulas Pierre

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference15 articles.

1. NIR spectroscopy on moving solids using a scanning grating spectrometer – impact on multivariate process analysis;Andersson;Chemom. Intell. Lab. Syst.,2005

2. Influence of physical factors on the accuracy of calibration models for NIR spectroscopy;Blanco;J. Pharm. Biomed. Anal.,2010

3. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation;El-Hagrasy;J. Pharm. Sci.,2006

4. FDA/ICH, 2006. Guidance for Industry. Q9 Quality Risk Management. Available at: http://www.fda.gov.cder/guidance/7153fnl.pdf.

5. FDA/ICH, 2009. Guidance for Industry. Q8 (R2) Pharmaceutical Development. Available at: http://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/Guidances/defaut.htm .

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