GDUFA Research Outcomes

LAI Products

• All(273)
• Posters(125)
• Presentations(72)
• Papers(76)

• Assessing In Situ Forming Implant Formulations Using In Vivo Imaging

  Lin, Xinhao; Al Zouabi, Nour; Ward, Lauren; Zhen, Zixuan; Masese, Francis; Hargrove, Derek; Yuan, Hong; Beringhs, Andre; Kasi, Rajeswari; Bin, Qin; Wang, Yan; Lu, Xiuling

• In-Vivo and Biopredictive In-Vitro Dissolution Testing of Dexamethasone Intravitreal Implants in Rabbits

  Johnson, Coleman; Maier, Esther; Bhalla, Aanya; Crowell, Eric; Wang, Yan; Qin, Bin; Zhang, Feng

• Formulation Insights into Long-Acting Hormonal Contraceptives for Advancing Generic Product Development

  Malavia, Nilesh; Silva, Daniela; Bao, Q; Lukacova, Viera; Alam, Khondoker; Wang, Yan; Burgess, Diane J

• Assessing Q1/Q2 Sameness of Polyethylene Glycol Star Polymers as Polymeric Excipients in Dexamethasone Ophthalmic Inserts

  Plavchak, Christine; Smith, William; Vandenberg, Michael; Zaman, Rokon; O’Reilly Beringhs, Andre; Wang, Yan; Xu, Xiaoming

• Reverse Engineering of Nexplanon® Contraceptive Implant: Physicochemical Properties and In Vitro Drug Release

  Zhong, Ziyue; Ren, Angela; Doluisio, Nicholas; Smith, W; Qin, Bin; Wang, Yan; Zhang, Feng

• Current Thinking and Rationale for When an In Vitro Approach to Establish Bioequivalence May be Recommended for an Injectable Suspension

  Zhang, Qiangnan; Cui, H; Qin, Bin; Wang, Y; Kozak, Darby

• Reverse Engineering of the Sublocade® Buprenorphine In Situ Forming Implant

  Poudel, Surendra; Pangeni, Rudra; Huo, Ziyu; Farkas, Dale; Zhang, Qiangnan; Wang, Yan; Qin, Bin; Longest, Worth; Tong, Rong; Halquist, Matthew S; Xu, Qingguo

• Deep Dive into Generic Drug Applications to Seek Data-Driven Harmonization of Bioequivalence Criteria for Narrow Therapeutic Index Drugs

  Mina, Mirette; Amin Anno, Krista; Zhang, Zhen; Sun, Wanjie; Zhang, Lei; Jiang, Wenlei

• Effect of Collagen Sources on the In-Vitro Performance of Collagen Implant

  Madawala, Chamika K; Srinivasan, Priyanka; Muhammad, Ali; Youngee, Seo; Korang-Yeboah, Maxwell; Xu, Xiamoning; Ashraf, Muhammad; Wang, Yan; Qin, Bin; Zhang, Qiangnan; Kamal, Nahid

• Development of a Coextrusion Process to Prepare Etonogestrel Long-Acting Implant

  Zhong, Ziyue; Ren, Angela; Qin, Bin; Wang, Yan; Zhang, Feng