SUPAC modified-release draft guidance allows annual report for batch variations under 2%.
This article was originally published in The Tan Sheet
Executive Summary
DRAFT SUPAC GUIDANCE COVERING MODIFIED-RELEASE DRUGS ALLOWS ANNUAL REPORT filing for changes that represent less than a 2% bath variation in release-controlling excipients. 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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