GDUFA Research Outcomes

Opioid Products

• All(45)
• Posters(21)
• Presentations(8)
• Papers(16)

• PK/PD meta-analysis of abuse deterrent opioid drug products: PSG Development, Research and ANDA Assessment

  Fang, Lanyan (Lucy)

• Physiologically Based Pharmacokinetic Modeling of Naloxone Hydrochloride Nasal Sprays

  Chopski, Steven; Al Ghabeish, Manar; Babiskin, Andrew; Zhao, Liang; Walenga, Ross

• Pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users

  Boyce, Heather

• Abuse Deterrent Assessment Template: Assessment of In Vitro Abuse Deterrent Evaluation Studies Submitted in Abbreviated New Drug Application (ANDA)

  Al Ghabeish, Manar

• Identifying Critical Parameters for Physiological Based Pharmacokinetic Modeling of Naloxone Hydrochloride Nasal Sprays

  Chopski, Steven; Al-Ghabeish, Manar; Babiskin, Andrew; Zhao, Laing; Walenga, Ross

• Evaluation of the Pharmacokinetics and Abuse Potential of Intranasally Administered Extended-Release Oxycodone and Naloxone Abuse-Deterrent Formulations Milled to Different Particle Sizes

  Al Ghabeish, Manar; Kinjo, Minori; Boyce, Heather; Oldennhof, John; Raitsin, Sofia; Myong-Jin, Kim

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, Changning

• 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

• Physical Manipulation of an Opioid Drug Product Containing Combination of Opioid Agonist and Antagonist

  Sun, Wei Jhe; Boyce, Heather; Tang, Fuxing; Hollenbeck, Robert; Ibrahim, Ahmed; Hoag, Stephen; Kim, Myong Jin