GDUFA Research Outcomes
LAI Products
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In Vitro Release Testing of Long-Acting Levonorgestrel Intrauterine System
Bao, Quanying; Gu, Bing; Price, Claire; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Impact of Manufacturing Process on Critical Quality Attributes of Multivesicular Liposomes
Bae, Jungeun; Patel, Mehulkumar; Manna, Soumyarwit; Smith, William; Vo, Anh; Wang, Yan; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen; Xu, Xiaoming
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Generic Long-acting Injectable Product Availability and Approval Standards
Anno, Krista Anim; Zhang, Lei; Jiang, Wenlei
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Development of In Vitro-In Vivo Correlation for Complex Parenteral Microsphere Drug Products — Effect of Burst Release
Andhariya, J; Jog, R; Shen, J; Zou, Y; Wang, Y; Choi, S; Burgess, D
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Development of In Vitro-In Vivo Correlation of Peptide Microspheres — Possibility and Challenges
Andhariya, J; Jog, R; Shen, J; Zou, Y; Wang, Y; Choi, S; Burgess, D
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Effect of Manufacturing Processes on Burst Release of Risperidone Microspheres
Andhariya, Janki; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Effect of Manufacturing Difference on the Drug Release Characteristics of Peptide Microspheres
Andhariya, Janki; Shen, Jie; Zou, Yuan; Choi, Stephanie; Wang, Yan; Burgess, Diane
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Evaluation of Effect of Minor Manufacturing Changes and Establishment of IVIVC for Compositionally Equivalent Parenteral Microsphere Drug Products
Andhariya, Janki; Jog, R; Shen, Jie; Zou, Yuan; Choi, Stephanie; Wang, Yan; Burgess, Diane
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Development of In Vitro-In Vivo Correlation of Parenteral Naltrexone Loaded Polymeric Microspheres
Andhariya, Janki; Shen, Jie; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Effect of Manufacturing Processes on Critical Quality Attributes of Peptide Microspheres
Andhariya, Janki; Shen, Jie; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane