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)

• Mechanistic Analysis of Triamcinolone Acetonide Release from PLGA Microspheres as a Function of Varying in Vitro Release Conditions

  Doty, Amy; Zhang, Ying; Weinstein, David; Wang, Yan; Choi, Stephanie; Qu, Wen; Mittal, Sachin; Schwendeman, Steven

• Characterizing Release Mechanisms of Leuprolide Acteate 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

• In Vitro-In Vivo Correlation of Parenteral PLGA Microspheres: Effect of Variable Burst Release

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

• Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy: The EQUIGEN Randomized Clinical Trial

  Berg, Michel; Welty, Timothy; Gidal, Barry; Diaz, Francisco; Krebill, Ron; Szaflarski, Jerzy; Dworetzky, Barbara; Pollard, John; Elder Jr, Edmund; Jiang, Wenlei; Jiang, Xiaohui; Switzer, Regina; Privitera, Michael

• Minimizing the Initial Burst of Octreotide Acetate from Glucose Star PLGA Microspheres Prepared by the Solvent Evaporation Method

  Beig, Avital; Ackermann, Rose; Wang, Yan; Schutzman, Richard; Schwendeman, Steven

• Surface Analysis of Sequential Semi-Solvent Vapor Impact (SAVI) for Studying Microstructural Arrangements of Poly(lactide-co-glycolide) Microparticles

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

• Impact of Product Design Parameters on In Vitro Release from Intrauterine Systems

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

• Effect of Polymer Source Variation on the Properties and Performance of Risperidone Microspheres

  Wan, Bo; Bao, Quanying; Zou, Yuan; Wang, Yan; Burgess, Diane

• Challenges and opportunities in the development of complex generic long-acting injectable drug products

  O’brien, Matthew; Jiang, Wenlei; Wang, Yan; Loffredo, David

• Complex Sameness: Separation of Mixed Poly(Lactide-co-Glycolide)s Based on the Lactide:Glycolide Ratio

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