GDUFA Research Outcomes
Opioid Products
-
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
-
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
-
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
-
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
-
In Vitro Method To Assess Performance Of Abuse Deterrent Formulations (Adfs) For Nasal Route Of Abuse
Boyce, Heather; Smith, Dan; Byrn, Steve; Saluja, Bhawana; Qu, Wen; Gurvich, Vivek; Hoag, Stephen