GDUFA Research Outcomes

Opioid Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to unique considerations impacting opioid drug products, including abuse deterrent formulations of generic opioid products.

• All(47)
• Posters(21)
• Presentations(9)
• Papers(17)

• Nasal Absorption of Oxycodone Predicted Using a Novel Computational Fluid Dynamics-Physiologically Based Pharmacokinetic Model

  Walenga, R L; Babiskin, Andrew; Boyce, Heather J; Feng, Xin; Zidan, Ahmed; Kamal, Nahid; Xu, Xiaoming; Kim, Myong-Jin; Zhao, Liang

• Regulatory Science in Action: Supporting Innovative Opioid Formulations Development & Advancing Overdose Treatments

  Al-Ghabeish, Manar

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, C

• A Chewing Study of Abuse-Deterrent Tablets Containing Polyethylene Oxide Using a Robotic Simulator

  Chen, Bangxiang; Zhang, Feng; Dhupia, Jaspreet; Morgenstern, Marco; Costello, Mark; Boyce, Heather; Sun, Wei-Jhe; Raofi, Saeid; Tian, Li; Xu, Weiliang

• Designs of Clinical Swallowability Assessments of Solid Oral Dosage Forms in Regulatory Submissions

  Mcguire, Meredith; Mostofa, Agm; Shon, Jihong; Frost, Mitchell; Kim, Myong-Jin; Li, Karen

• Understanding Syringeability and Injectability of High Molecular Weight PEO Solution through Time-Dependent Force-Distance Profiles

  Feng, Xin; Wu, Kai-Wei; Balajee, V; Leissa, Jesse; Ashraf, Muhammad; Xu, Xiaoming

• Asymmetrical Flow Field Flow Fractionation for Molar Mass Characterization of Polyethylene Oxide in Abuse-Deterrent Formulations

  Qu, Haiou; Smith, William C; Feng, Xin; Wang, Jiang; Pinto, Julia; Xu, Xiaoming; Faustino, Patrick J

• Determining Critical Overlap Concentration of Polyethylene Oxide to Support Excipient Safety Assessment of Opioid Products

  Smith, William; Qu, Haiou; Zheng, Kai; Baek, J; Gao, Yamei; Buehler, P; Feng, X; Xu, Xiaoming

• In Vitro Assessment of Nasal Insufflation of Comminuted Drug Products Designed as Abuse Deterrent Using the Vertical Diffusion Cell

  Boyce, Heather; Smith, Dan; Byrn, Steve; Saluja, Bhawana; Qu, Wen; Gurvich, Vadim; Hoag, Stephen

• Evaluation of Abuse-Deterrent Characteristics of Tablets Prepared via Hot-Melt Extrusion

  Xu, Xiaoming; Siddiqui, Akhtar; Mohammad, Adil; Srinivasan, Charudharshini; Rahman, Ziyaur; Korang Yeboah, Maxwell; Feng, Xin; Khan, Mansoor; Ashraf, Muhammad