Validation of Raman spectroscopic procedures in agreement with ICH guideline Q2 with considering the transfer to real time monitoring of an active coating process

Author:

Müller Joshua,Knop Klaus,Wirges Markus,Kleinebudde Peter

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference40 articles.

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4. Food and Drug Administration (FDA), Guidance for industry PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf, 2004 (accessed February 28, 2010).

5. Process analytical applications of Raman spectroscopy;Rantanen;J. Pharm. Pharmacol.,2007

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