RE: Inquiry - SUPAC evaluation for Modified Release product Contribution from JD Mallet written on 8/22/2010 at 14:04
Original contribution: Inquiry - SUPAC evaluation for Modified Release product written by Deepak Kheni on 8/18/2010 at 09:40) Dear Deepak,
Because your product is a MR tablet the fact that you will change the coating material amount is a "real" change that should be, to my opinion, submitted (with the requested validation data) to the FDA prior to proceed.
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