GDUFA Research Outcomes

LAI Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to long-acting injectable, insertable or implantable (collectively, LAI) generic products.

• All(272)
• Posters(124)
• Presentations(72)
• Papers(76)

• Application Of USP 4 Dissolution Apparatus To Assess Dissolution Of Microparticles For Periodontal Disease.

  Patel, Sravankumar; Greene, Ashlee; Rothstein, Sam; Zou, Yuan; Choi, Stephanie; Glowacki, Andrew; Gottardi, Riccardo; Sfeir, Charles; Little, Steven; Rohan, Lisa

• Evaluation of Deficiencies Associated with In-vitro Release Test Submitted in Abbreviated New Drug Applications to Support Bioequivalence of Acyclovir Ointment

  Patel, Sravankumar; Greene, Ashlee; Rothstein, Sam; Zou, Yuan; Choi, Stephanie; Glowacki, Andrew; Gottardi, Riccardo; Sfeir, Charles; Little, Steven; Rohan, Lisa

• Development Of An In Vitro Mechanistic Model That Describes Drug Release From Risperidone Long-Acting Injectable Microspheres

  Mullin, James; Lukacova, Viera; Woltosz, Walter; Bolger, Michael

• Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres

  Mullin, James; Van Osdol, William; Lukacova, Viera; Woltosz, Walter; Bolger, Michael

• Significance of Cryogenic Broad Ion Beam Milling in Evaluating Microstructures of PLGA-based Drug Products

  Ma, Youlong; Liang, Jing; Zheng, Jiwen; Wang, Yan; Ashraf, Muhammad; Srinivasan, Charudharshini

• Assessing In Situ Forming Implant Formulations Using In Vivo Imaging

  Lin, Xinhao; O’Reilly Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Bin, Qin; Lu, Xiuling

• Assessing In Situ Forming Implants Using Real-Time Imaging

  Lin, Xinhao; Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Bin, Qin; Lu, Xiuling

• Assessing Long-Acting Injectable Formulations Using In Vivo Imaging

  Lin, Xinhao; Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Qin, Bin; Lu, Xiuling

• Micro-imaging and Microanalysis of PLGA Complex Drug Products by Scanning Electron Microscopy (SEM)

  Liang, Jing; Wang, Yan; Qin, Bin; Zhou, Jia; Schwendeman, Steven; Zheng, Jiwen

• Bioequivalence Testing of Complex Periodontal Products: Drug Release, Matrix Degradation, and Pharmacodynamics in a Canine Periodontal Disease Model

  Kozak, Darby; Wang, Yan; Choi, Stephanie; Park, Misook; De Lannoy, Ines; Ines; Brooks, Melissa; Araujo, Joseph