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EMEA: Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1

28.02.2009
EMEA:
Draft guideline on the use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations Rev. 1.
This guideline provides guidance on the development, calibration, validation and maintenance of NIRS methods and the data to be submitted to the competent authorities when NIRS is the subject or part of a marketing authorization application.