Can I read SUPAC Guidelines for Scale-Up Changes on EtoBox?

SUPAC Guidelines for Scale-Up Changes by shivani is a document available to read on EtoBox.

What is SUPAC Guidelines for Scale-Up Changes about?

The document discusses SUPAC (Scale Up and Post Approval Changes) guidelines for different drug products. It defines three levels of changes based on their likelihood of impacting formulation quality and performance. It then provides SUPAC classification systems and recommended tests and documentation for: SUPAC-IR (immediate release), SUPAC-MR (modified release with non-release controlling and release controlling excipients), and SUPAC-SS (semi-solid drug products). The guidelines help determine the approp

Author

shivani

Language

EN