SUPAC modified release draft guidance allows annual report for batch variations less than 2%.
SUPAC-MR ALLOWS ANNUAL REPORT FOR LESS THAN 2% BATCH VARIATION in release-controlling excipients in all drugs. The Scale-Up and Postapproval Changes draft for Modified-Release Solid Oral Dosage Forms states that for Level 1 changes, a "total additive effect of all release-controlling excipient changes should not be more than 2% [by weight] of the total release-controlling excipients in the original approved formulation."
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