AAPS Update

  • Published 2006 in Pharmaceutical Research

Abstract

The U.S. Food and Drug Administration took a proactive approach to bring a scientific and risk-based framework founded on pharmaceutical process understanding, which is essential for prediction of product quality attributes. As a result of this proactive approach, PAT and QbD initiatives gained momentum amongst the pharmaceutical scientists. However, there seems to be little clarity on how to implement the concepts of PAT and QbD in real world applications, to get drug applications approved by the agency. Although many events (in the form of symposiums and workshops, etc.) have been organized to address these issues, we believe none of the programs were directed at showing case examples of PAT and QbD in new drug applications and the feedback for streamlining the process. Industry is eager to understand the risk/ benefits and especially the return on investments by applying PAT and QbD. This workshop is geared to provide discussion on these topics. For more information and to register, please visit http:// www.aapspharmaceutica.com/meetings

DOI: 10.1007/s11095-006-9125-z

Cite this paper

@article{2006AAPSU, title={AAPS Update}, author={}, journal={Pharmaceutical Research}, year={2006}, volume={23}, pages={1949-1950} }