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(202)
• Posters(97)
• Presentations(51)
• Papers(54)

• Reverse Engineering the 1-Month Lupron Depot®

  Zhou, Jia; Hirota, Keiji; Ackermann, Rose; Walker, Jennifer; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven

• Analysis of Semi-Solvent Effects for PLGA Polymers

  Garner, John; Skidmore, Sarah; Hadar, Justin; Park, Haesun; Park, Kinam; Jhon, Young Kuk; Qin, Bin; Wang, Yan

• Impact of Polymer Crosslinking on Release Mechanisms from Long-Acting Levonorgestrel Intrauterine Systems

  Fanse, Suraj; Bao, Quanying; Zou, Yuan; Wang, Yan; Burgess, Diane J

• Development and characterization of composition-equivalent formulations to the Sandostatin LAR® by the solvent evaporation method

  Beig, Avital; Feng, Linglin; Walker, Jennifer; Ackermann, Rose; Hong, Justin; Li, Tinghui; Wang, Yan; Schwendeman, Steven

• Characterization of Branched Poly(Lactide-co-Glycolide) Polymers Used in Injectable, Long-Acting Formulations

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

• The Effect of PLGA Molecular Weight Differences on Risperidone Release from Microspheres

  Kohno, Moe; Andhariya, Janki; Wan, Bo; Bao, Quanying; Rothstein, Sam; Hezel, Michael; Wang, Yan; Burgess, Diane

• Validation of a Cage Implant System for Assessing In Vivo Performance of Long-Acting Release Microspheres

  Doty, Amy; Hirota, Keiji; Olsen, Karl; Sakamoto, Naoya; Wang, Yan; Choi, Stephanie; Qu, Wen; Schwemdeman, Anna; Schwendeman, Steven

• Development of Level A In Vitro-In Vivo Correlations for Peptide Loaded PLGA Microspheres

  Andhariya, Janki; Jog, Rajan; Shen, Jie; Choi, Stephanie; Wang, Yan; Zou, Yuan; Burgess, Diane

• Potential roles of the glass transition temperature of PLGA particles in drug release kinetics

  Park, Kinam; Otte, Andrew; Sharifi, Farrokh; Garner, John; Skidmore, Sarah; Park, Haesun; Jhon, Young Kuk; Qin, Bin; Wang, Yan

• Characterization of Attributes and In Vitro Performance of Exenatide-Loaded PLGA Long-Acting Release Microspheres

  Li, Tinghui; Chandrashekar, Aishwarya; Beig, Avital; Walker, Jennifer; Hong, Justin; Benet, Alexander; Kang, Jukyung; Ackermann, Rose; Wang, Yan; Qin, Bin; Schwendeman, Anna; Schwendeman, Steven