GDUFA Research Outcomes

QCP Methods

• All(138)
• Posters(42)
• Presentations(65)
• Papers(31)

• The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

  Fang, Lanyan; Gong, Yuqing; Hooker, A; Lukacova, Viera; Rostami-Hodjegan, Amin; Sale, Mark; Grosser, Stella; Jereb, Rebeka; Savic, Rada; Peck, Carl; Zhao, Liang

• Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

  Pal, Arindom; Wu, Fang; Walenga, Ross; Tsakalozou, Eleftheria; Alam, Khondoker; Gong, Yuqing; Liang, Zhao; Fang, Lanyan

• Evaluation of Model – Based Bioequivalence Approach for Single Pharmacokinetic Studies

  Tardivon, Coralie; Loingeville, Florence; Donnelly, Mark; Feng, Kairui; Sun, Wanjie; Sun, Guoying; Grosser, Stella; Zhao, Liang; Fang, Lanyan (Lucy); Mentre, France; Bertrand, Julie

• Increasing Impact of Quantitative Methods and Modeling in Establishment of Bioequivalence and Characterization of Drug Delivery

  Yoon, Miyoung; Babiskin, Andrew; Hu, Meng; Wu, Fang; Raney, Sam G.; Fang, Lanyan; Zhao, Liang

• Public Workshop Summary Report on FY2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence

  Lee, Jieon; Gong, Yuqing; Bhoopathy, Sid; Diliberti, Charles; Hooker, Andrew; Rostami-Hodjegan, Amin; Schmidt, Stephan; Suarez-Sharp, Sandra; Lukacova, Viera; Fang, Lanyan; Zhao, Liang

• Therapeutic Index Estimation of Antiepileptic Drugs: A Systematic Literature Review Approach

  Greenberg, Rachel; Melloni, Chiara; Wu, Huali; Gonzalez, Daniel; Ku, Lawrence; Hill, Kevin; Hornik, Christoph; Zheng, Nan; Jiang, Wenlei; Cohen Wolkowiez, Michael; Guptill, Jeffrey

• Model-Informed Drug Development for Long-Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium

  Sharan, Satish; Fang, Lanyan; Lukacova, Viera; Chen, Xiaomei; Hooker, Andrew; Karlsson, Mats

• Generic Lamotrigine Extended-Release Tablets are Bioequivalent to Innovator Drug in Fully Replicated Crossover Bioequivalence Study

  Fang, Lanyan; Li, Zhichuan; Kinjo, Minori; Lomonaco, Sara; Zheng, Nan; Jiang, Wenlei; Zhao, Liang

• Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

  Stier, Ethan; Davit, Barbara; Chandaroy, Parthapratim; Chen, Meiling; Fourie Zirkelbach, Jeanne; Jackson, Andre; Kim, Stephanie; Lionberger, Robert; Mehta, Mehul; Uppoor, Ramana; Wang, Yaning; Yu, Lawrence; Conner, Dale

• Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine

  Ku, Lawrence; Wu, Huali; Greenberg, Rachel; Hill, Kevin; Gonzalez, Daniel; Hornik, Christoph; Berezny, Alysha; Guptill, Jeffrey; Jiang, Wenlei; Zheng, Nan; Cohen Wolkowiez, Michael; Melloni, Chiara