See below for information on how to register for upcoming events

Understanding measurement of particle size distribution (PSD) is crucial in developing methods for quality control (QC) and demonstrating bioequivalence (BE) for pharmaceutical products. However, development, optimization, and validation of these methods can be challenging. This is in part because particle sizing is a poorly posed problem; and the apparent simplicity of the particle size analysis is deceptive. This seminar will provide a high-level overview of particle sizing techniques, covering both theoretical and practical applications, as well as common deficiencies and challenges. Additionally, method of producing complex parenteral product through continous manufacturing will also be introduced.

Xiaoming Xu serves as a Division Director in the Office of Pharmaceutical Quality Research in FDA, where he leads multiple regulatory research areas such as complex formulations, nanomaterials and advanced manufacturing. In support of GDUFA III implementation, Xiaoming co-leads the complex PSG working group, with a focus of better integrating research in complex PSG development. He is also a member of FDA Nanotechnology Task Force and is responsible for developing international collaborative programs and standards in areas related to nanotechnology. Xiaoming is an editorial board member of the International Journal of Pharmaceutics. He received his B.S. and M.S. degrees in Pharmaceutics from China Pharmaceutical University and Ph.D. degree in Pharmaceutical Sciences from University of Connecticut.