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Guideline on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for News Submissions and Variations
Short Title:
EMEA/CHMP/CVMP/QWP/17760/2009 Rev 1
Origin/Publisher:
EMEA
Document Type:
CHMP Guideline
Content:
This guideline is intended to provide guidance in the process of calibration, validation and maintenance of a Near Infrared Spectroscopy (NIRS) method and the type of data to be submitted to the competent authorities in the case that NIRS is subject or part of an application.
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