GDUFA Research Outcomes
Opioid Products
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Effect of Formulation Variables on the Nasal Permeability and Stability of Naloxone Intranasal Formulations
Hsu, Haojui; Yang, Yang; Pavuluri, Venkateswara; Abraham, Ciby; Naraharisetti, Suresh; Ashraf, Muhammad; Al Ghabeish, Manar
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Physical Barrier Type Abuse-Deterrent Formulations: Monitoring Sintering-Induced Microstructural Changes in Polyethylene Oxide Placebo Tablets by Near Infrared Spectroscopy (NIRS)
Boyce, Heather; Ibrahim, Ahmed; Hoag, Stephen
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Particle Size Affects Pharmacokinetics of Milled Oxycodone Hydrochloride Tablet Products Following Nasal Insufflation in Nondependent, Recreational Opioid Users
Raofi, Saeid; Kinjo, Minori; Sun, Dajun; Li, Zhichuan; Boyce, Heather; Natarajan, Karthika; Frost, Mitchell; Zhao, Liang; Luke, Markham; Lionberger, Robert; Kelsh, Debra; Kim, Myoung Jin
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An In Vitro Approach for Evaluating the Oral Abuse Deterrence of Solid Oral Extended-Release Opioids with Properties Intended to Deter Abuse via Chewing
Externbrink, Anna; Sharan, Satish; Sun, Dajun; Jiang, Wenlei; Keire, David; Xu, Xiaoming
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Physical Barrier Type Abuse-Deterrent Formulations: Mechanistic Understanding of Sintering-Induced Microstructural Changes in Polyethylene Oxide Placebo Tablets
Boyce, Heather; Dave, Vivek; Scoggins, Myke; Gurvich, Vadim; Smith, Daniel; Byrn, Stephen; Hoag, Stephen
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Preferential Oxycodone Loss of Physically Manipulated Abuse Deterrent Oxycodone HCl Extended Release Tablets Prepared for Nasal Insufflation Studies
Meng, Zhengjie; Boyce, Heather; Sun, Dajun; Kinjo, Minori; Raofi, Saeid; Li, Tonglei
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Quantitative Analysis of Opioid ADF PK/PD
Zhao, Liang
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Foundations of PK Comparisons of Generic Opioids to RLDs with Labeling Describing Abuse-deterrent Properties
Zhao, Liang
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In Vitro and in Vivo Abuse Deterrence Evaluation of Generic Opioid Products
Xu, Xiaoming
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Nasal PK Study of Abuse-Deterrent Opioid Products Following Insufflation of Physically Manipulated Products
Vince, Bradley