Eudralex Volume 3 Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations
Titel:
Eudralex Volume 3 Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations
Internet:
Herkunft/Verlag:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Dokumentenart:
ICH Guideline
Inhalt:
This concept paper addresses the need to update the CPMP/CVMP ‘Note for Guidance on the use of
Near infrared spectroscopy by the pharmaceutical industry and the data requirements for new
submissions and variations’ (1). The update is necessary in the light of recent developments in this
area, regulatory experience and feedback from pharmaceutical industry (2,3,4).