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.
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Preparation and Characterization of Physically Manipulated Abuse-Deterrent Formulation of an Opioid Product Prepared for Nasal Insufflation Studies
Gabal, Yasmine; Boyce, Heather; Sun, Wei Jhe; Al Ghabeish, Manar; Ibrahim, Ahmed; Hollenbeck, Gary; Hoag, Stephen; Mostofa, AGM; Kim, Myong Jin
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Preparation and Characterization of Physically Manipulated Abuse-Deterrent Formulation of an Opioid Product Prepared for Nasal Insufflation Studies
Gabal, Yasmine; Boyce, Heather; Sun, Wei Jhe; Al Ghabeish, Manar; Ibrahim, Ahmed; Hollenbeck, Gary; Hoag, Stephen; Mostofa, AGM; Kim, Myong Jin
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A Flow-Through Dissolution Method for Evaluation of Drug Release from Manipulated Abuse Deterrent Formulations
Feng, Xin; Zidan, Ahmed; Kamal, Nahid; Xu, Xiaoming; Sun, Dajun; Walenga, Ross; Boyce, Heather; Cruz, Celia; Ashraf, Muhammad
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Development of an In-Vitro Chewing Method for Determining Opioid Availability Following Chewing of Solid Oral Extended-Release Opioids
Externbrink, Anna; Sun, Dajun; Sharan, Satish; Saluja, Bhawana; Gao, Zongming; Keire, David; Jiang, Wenlei
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Physiologically-Based Pharmacokinetic Model to Describe the Pharmacokinetics of Crushed Morphine Sulfate and Naltrexone Hydrochloride Extended-Release Capsules with Abuse Deterrent Properties
Chopski, Steven; Walenga, Ross; Boyce, Heather; Babiskin, Andrew; Kim, Myong Jin
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Pharmacokinetic Study of Physically Manipulated Oxycodone Hydrochloride Products Following Nasal Insufflation in Recreational Opioid Users
Boyce, Heather; Sun, Dajun; Kinjo, Minori; Raofi, Saeid; Frost, Mitchell; Luke, Markham; Kim, Myong Jin; Jin; Lionberger, Robert; Vince, Brad; Kelsh, Debra; Li, Zhichuan
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Pharmacokinetic Study of Physically Manipulated Oxycodone Hydrochloride Products Following Nasal Insufflation in Recreational Opioid Users
Boyce, Heather; Sun, Dajun; Kinjo, Minori; Raofi, Saeid; Frost, Mitchell; Luke, Markham; Kim, Myong Jin; Lionberger, Robert; Vince, Brad; Kelsh, Debra; Li, Zhichuan
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Influence Of Key Polymer Attributes, Manufacturing Conditions And Sintering On Abuse Deterrence Of Physical Barrier Type Abuse Deterrent Formulations (Adf)
Boyce, Heather; Dave, Vivek; Scoggins, Myke; Smith, Dan; Byrn, Steve; Saluja, Bhawana; Qu, Wen; Gurvich, Vadim; Hoag, Stephen
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Use Of A Vertical Diffusion Cell For The In Vitro Assessment Of Abuse Deterrence Of Comminuted Abuse Deterrent Formulations
Boyce, Heather; Smith, Dan; Byrn, Steve; Saluja, Bhawana; Qu, Wen; Gurvich, Vivek; Hoag, Stephen
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Investigation Of Abuse Deterrent Properties Of Sintered Polyethylene Oxide And Hypromellose Placebo Tablets
Boyce, Heather; Smith, Dan; Byrn, Steve; Saluja, Bhawana; Qu, Wen; Gurvich, Vivek; Hoag, Stephen