Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

SUPAC modified-release draft guidance allows annual report for batch variations under 2%.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."
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS085909

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel