2021 Research Conference

Xiaoming Xu, PhD, CDER, FDA

Dr. Xiaoming Xu received his B.S. and M.S. degrees in Pharmaceutics from China Pharmaceutical University and Ph.D. degree in Pharmaceutical Science from University of Connecticut. He serves as Lab Chief in Division of Product Quality Research in Office of Testing and Research in FDA, where he leads multiple regulatory science research areas such as complex formulations, nanomaterials and advanced manufacturing. Xiaoming is a passionate educator and mentor. He has developed and directed several training courses within the FDA on complex and challenging topics such as particle size analysis and in vitro drug release testing. He has mentored 14 postdoctoral fellows and summer students. Xiaoming is a member of FDA Nanotechnology Task Force and is responsible for developing international collaborative programs and standards in areas related to nanotechnology. He has published over 50 peer-reviewed journal articles and is an editorial board member of the International Journal of Pharmaceutics.

In Vitro Release Test for Complex Drug Products: Start with Why

Measuring drug release from complex products that contain particulates (e.g., emulsions, micelles,
suspensions, ointments, liposomes and implants) can be challenging but are considered critical tests of
product quality and performance. An ideal in vitro drug release test (IVRT) should be able to detect
critical manufacturing process changes as well as variations in the product quality and performance.
However, not all commonly used methods can achieve the desired goal. In this presentation, two
examples of IVRT for complex products will be presented. Key considerations in developing as well as
assessing these IVRT methods will also be discussed.