Subscribe
  
IPQ Inside the global regulatory dialogue

Analysis of Post-Change Comparability and PEGylation Among Biotech CMC Concerns Drawing FDA Comment at AAPS National Biotech Conference

Jun 16th, 2012

Please Log in to print the full article

The expectations for pre- and post-change lot comparisons and for PEGylation analysis were among FDA CMC application filing concerns addressed by CDER Office of Biotechnology Products (OBP) official Susan Kirschner at an “ask the regulator”...

You must be a paid subscriber to continue reading this article. If you are a paid subscriber, please Log in. If you are not a paid subscriber, please subscribe now.

©2021 IPQ Publications