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(36)
• Posters(18)
• Presentations(8)
• Papers(10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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