Comment from Kejun Cheng
AnonymousSupportOther
Summary: The commenter recommends updating the relevant Guidances for Industry regarding Scale-Up and Postapproval Changes to align with the ICH Q12 framework. They also suggest updating the list of Narrow Therapeutic Range Drugs in Appendix A of the SUPAC-IR guidance.
1. Recommend to update the relevant Guidances for Industry Scale-Up and Postapproval Changes per ICH Q12, which provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes.
2. Recommend to update Narrow Therapeutic Range Drugs in Appendix A of SUPAC-IR: Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation