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)

• The Effect of PLGA Molecular Weight on Drug Release from Microspheres

  Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane

• Characterizing Release Mechanisms of Leuprolide Acetate-loaded PLGA Microspheres for IVIVC development I: In Vitro Evaluation

  Hirota, Keiji; Doty, Amy; Ackermann, Rose; Zhou, Jia; Olsen, Karl; Feng, Meihua; Wang, Yan; Choi, Stephanie; Qu, Wen; Schwendeman, Anna; Schwendeman, Steven

• Reverse engineering of the one-month Lupron Depot

  Hirota, Keiji; Zhou, Jia; Ackerman, Rose; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven

• Characterizing Release Mechanisms of Leuprolide-Loaded PLGA Microparticles for IVIVC Development

  Hirota, Keiji; Doty, Amy; Ackerman, Rose; Olsen, Karl; Feng, Meihua; Wang, Yan; Choi, Stephanie; Qu, Wen; Schwendeman, Anna; Schwendeman, Steven

• Compositional Analysis of Glucose-poly(lactide-co-glycolide) in Sandostatin®LAR Formulation

  Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Qin, Bin; Jiang, Xiaohui; Wang, Yan

• Analysis of the Branch Units of Glucose-poly(lactide-co-glycolide) in Sandostatin® LAR Formulation

  Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Qin, Bin; Jiang, Xiaohui; Wang, Yan

• Correlation analysis of refractive index (dn/dc) for PLGAs with different ratios of lactide to glycolide,

  Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Kozak, Darby; Wang, Yan

• The Effect of Lactide:Glycolide Ratio on PLGA Solubility in Selective Solvents

  Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Kinam; Choi, Stephanie; Wang, Yan

• Solvent-dependent PLGA Solubility for Separation of PLGAs with Different L:G Ratios

  Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Kozak, Darby; Jiang, Xiaohui; Wang, Yan

• Morphological Analysis of Naltrexone-Poly(lactide-co-glycolide) (NTX-PLGA) Microparticles: Dynamic Role of Naltrexone on PLGA Degradation

  Garner, J; Hadar, J; Skidmore, S; Jessmon, F; Park, H; Park, K; Qin, B; Jhon, Y K; Wang, Y