GDUFA Research Outcomes

QCP Methods

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to quantitative clinical pharmacology assessments of oral absorption to support generic product development and assessment.

• All(110)
• Posters(37)
• Presentations(56)
• Papers(17)

• Applications of Adaptive Designs in Generic Drug Development

  Lee, Jieon; Feng, Kairui; Xu, Mingjiang; Gong, Xiajing; Sun, Wanjie; Kim, Jessica; Zhang, Zhen; Wang, Meng; Fang, Lanyan; Zhao, Liang

• Model Based Assessment Using Conventional BE Limits to Ensure Safety and Efficacy of Rivaroxaban in Patients Undergoing Hip or Knee Replacement

  Gonzalez Sales, Mario; Fang, Lanyan; Kim, Myongjin; Zhao, Liang

• Using Partial Area for Evaluation of Bioavailability and Bioequivalence

  Chen, Meiling; Davit, Barbara; Lionberger, Robert; Wahba, Zakaria; Ahn, Haeyoung; Yu, Lawrence

• Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure-Response Relationships in Renal Transplant Patients

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

• New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling

  Loingeville, Florence; Bertrand, Julie; Nguyen, Thu Thuy; Sharan, Satish; Feng, Kairui; Sun, Wanjie; Han, Jing; Grosser, Stella; Zhao, Liang; Fang, Lanyan; Mollenhoff, Kathrin; Dette, Holger; Mentre, France

• Impact of Model Misspecification on Model-Based Tests in PK Studies with Parallel Design: Real Case and Simulation Studies

  Guhl, Melanie; Mercier, Francois; Hofmann, Carsten; Sharan, Satish; Donnelly, Mark; Feng, Kairui; Sun, Wanjie; Sun, Guoying; Stella, Grosser; Zhao, Liang; Fang, Lanyan; Mentre, France; Comets, Emmanuelle; Bertrand, Julie

• Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations

  Lionberger, Robert; Raw, Andre; Kim, Stephanie; Zhang, Xinyuan; Yu, Lawrence

• Regulatory Perspective on Modeling Strategies Across Multiple Submissions

  Babiskin, Andrew; Yoon, Miyoung

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• General Overview: The Use of Quantitative Methods and Modeling to Facilitate Generic Drug Development and Regulatory Assessment

  Zhao, Liang