PAT for tableting: Inline monitoring of API and excipients via NIR spectroscopy

Author:

Wahl Patrick R.,Fruhmann Georg,Sacher Stephan,Straka Gerhard,Sowinski Sebastian,Khinast Johannes G.

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference44 articles.

1. U.S. Food and Drug Administration, Guidance for Industry. PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, US Department of Health, Rockville, MD, 2004.

2. ICH, ICH Q8(R2) (Pharmaceutical Development), ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System) and ICH Q11 (Development and Manufacture of Drug Substances).

3. An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation;Adam;Eur. J. Pharm. Sci.,2011

4. Near-infrared spectroscopy in the pharmaceutical industry;Blanco;Analyst,1998

5. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes;De Beer;Int. J. Pharm.,2011

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