4th PQRI/FDA Conference on Advancing Product Quality – Posters

Biopharmaceutics
Title	Authors
Analysis of Complex Drug Product Landscape to Support Generic Drug User Fee Amendment (GDUFA) II Implementation	Meng Hu, Andrew Babiskin, Xiajing Gong, Liang Zhao, Robert Lionberger, Lei Zhang, Wenlei Jiang
Assessment of In Vivo Bioperformance for Enalapril Maleate (MK-0421) between Co-Renitec Tables Manufactured at Two Different Sites Via Deconvolution Analysis and PBAM Modeling Poster	Wei Zhu, Filippos Kesisoglou
How are Complex Drug Products Defined and Classified?	Wenlei Jiang, Darby Kozak, Deyi Zhang, Yan Wang, Sam G. Raney, Yi Zhang, Dajun Sun, Sue Chih Lee, Kimberly Witzmann, Xiaohui Jiang, Markham C Luke, Robert Lionberger, Lei Zhang
Development
Accelerated PK Screening Study of Formulation Design Space in Early Drug Development Poster	Leah Xiong, Gerard Byrne, Andrew Farrington, Nathan Contrella, Walter Wasylaschuk, Susi Lee, Nazia Khawaja, Wei Zhu , Lorente Bonaga, Karl SchaferDumindika Siriwardane, Changguang Wang, Wenlei Jiang, Thilak Mudalige
Enablement of Patient Centric Solutions Through Integrating Drug – Device Development Poster	Fran L. DeGrazio
Enabling Patient Centricity in Clinical Development through at Home Sample Collection Poster	Melanie Anderson, Marissa Dockendorf, Lingling Xue, Dan Dreyer, Deanne Rudd and Kevin P. Bateman
Evaluation of size-based distribution of drug and excipient in Amphotericin B liposomal formulation	Desiree Van Hautea, Wenlei Jiang, Thilak Mudalige
Quantitative analysis of cholesterol oxidation products and desmosterol in parenteral liposomal drug products	Changguang Wang, Dumindika A. Siriwardane, Wenlei Jiang, Thilak Mudalige
Quantification of lysophosphatidylcholines in Parenteral Liposomal Formulations by Liquid Chromatography – Mass Spectroscopy (LC-MS)	Dumindika A. Siriwardane, Changguang Wang, , Wenlei Jiang, Thilak Mudalige
Manufacturing
Considerations and Observations when Validating and Verifying Drug Substance/Drug Product Assay or Related Substance Methods for ANDA Submissions Poster	Rui Zhu
Stability Study to Ensure Abuse Deterrent Properties During Shelf Life of Abuse Deterrent Formulation of Opioids Poster	Golam Kibria, Celia N. Cruz