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.
-
Quantitative Analysis of Opioid ADF PK/PD
Zhao, Liang
-
Foundations of PK Comparisons of Generic Opioids to RLDs with Labeling Describing Abuse-deterrent Properties
Zhao, Liang
-
Foundations of Pharmacokinetic Comparisons of Generic Opioids to RLDs with Labeling Describing Abuse Deterrent Properties
Zhao, Liang
-
Pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users
Boyce, Heather
-
In Vitro and in Vivo Abuse Deterrence Evaluation of Generic Opioid Products
Xu, Xiaoming
-
Nasal PK Study of Abuse-Deterrent Opioid Products Following Insufflation of Physically Manipulated Products
Vince, Bradley
-
PK/PD meta-analysis of abuse deterrent opioid drug products: PSG Development, Research and ANDA Assessment
Fang, Lanyan (Lucy)
-
Abuse Deterrent Assessment Template: Assessment of In Vitro Abuse Deterrent Evaluation Studies Submitted in Abbreviated New Drug Application (ANDA)
Al Ghabeish, Manar
-
Hybrid CFD-PBPK Model for Prediction of Systemic PK Following Nasal Insufflation of Milled Oxycodone Hydrochloride Extended-Release Tablets
Walenga, Ross; Boyce, Heather; Feng, Xin; Zidan, Ahmed; Kamal, Nahid; Xu, Xiaoming; Babiskin, Andrew; Kim, Myong Jin; Zhao, Liang
-
Evaluation of the Internal and External Structure of Directly Compressed Polyethylene Oxide (PEO) Based Matrix Tablets Before and after Curing Using X-ray Micro-Computed Tomography
Vaghasia, Brijeshkumar; Aqueel, Mohammad Sabir; Ashraf, Muhammad; Cruz, Celia; Siddiqui, Akhtar