CMC Policy and Advocacy, Global CMC Regulatory Affairs, GSK, 1250 S. Collegeville Rd, Collegeville, PA 19426, United States.

FDA/M-CERSI Co-Processed API Workshop Proceedings.

Published in Journal of Pharmaceutical Sciences

These proceedings contain presentation summaries and discussion highlights from the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) Workshop on Co-processed API, held on July 13 and 14, 2022. This workshop examined recent advances in the use of co-processed active pharmaceutical ingredients as a technology...