DCGI application for change in RLD [Regulatives / Guidelines]

posted by drgunasakaran1  – 2013-06-24 08:27 (4749 d 03:22 ago) – Posting: # 10867
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Dear Dr Sudakar Reddy,

DCGI insists for new BENOC application since the Certificate of Analysis of new RLD to be used in the BE study and the dissolution profile differs for the new RLD vs test formulation.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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