Eudralex Volume 3 Guideline on the use of Near Infrared Spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations
Titel:
Eudralex Volume 3 Guideline on the use of Near Infrared Spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations
Kurztitel:
EMEA/CHMP/CVMP/QWP/17760/2009 Rev 2
Internet:
Herkunft/Verlag:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Dokumentenart:
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).