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)

• Physical-Chemical Characterization of Octreotide Encapsulated in Commercial Glucose-Star PLGA Microspheres

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

• Stochastic and Deterministic Analysis of Reactivity Ratios in the Partially Reversible Copolymerization of Lactide and Glycolide

  Kuehster, Louise; Jhon, Young Kuk; Wang, Yan; Smith, William C; Xu, Xiaoming; Qin, Bin; Zhang, Feng; Lynd, Nathaniel A

• Beyond Q1/Q2: The Impact of Manufacturing Conditions and Test Methods on Drug Release from PLGA-Based Microparticle Depot Formulations

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

• Scanning Analysis of Sequential Semisolvent Vapor Impact To Study Naltrexone Release from Poly(lactide-co-glycolide) Microparticles

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

• Biorelevant and Screening Dissolution Methods for Minocycline Hydrochloride Microparticles Intended for Periodontal Administration

  Patel, Sravan; Greene, Ashlee; Desai, Stuti; Rothstein, Sam; Basha, Iman; Macpherson, James; Wang, Yan; Zou, Yuan; Shehabeldbin, Mostafa; Sfeir, Charles; Little, Steven; Rohan, Lisa

• Effect of Minor Manufacturing Changes on Stability of Compositionally Equivalent PLGA Microspheres

  Andhariya, Janki; Shen, Jie; Wang, Yan; Choi, Stephanie; Burgess, Diane

• Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• In Vitro-in Vivo Correlation of Parenteral Risperidone Polymeric Microspheres

  Shen, Jie; Choi, Stephanie; Qu, Wen; Wang, Yan; Burgess, Diane

• Method Matters: Development of characterization techniques for branched and glucose-poly(lactide-co-glycolide) polymers

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

• Drug Release Testing of Long-Acting Intrauterine Systems

  Bao, Quanying; Zou, Yuan; Wang, Yan; Kozak, Darby; Choi, Stephanie; Burgess, Diane