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

• Efficient model-based Bioequivalence Testing

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

• Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective

  Fang, Lanyan; Uppoor, Ramana; Xu, Mingjiang; Sharan, Satish; Zhu, Hao; Tampal, Nilufer; Li, Bing; Zhang, Lei; Lionberger, Robert; Zhao, Liang

• Impact of Sex on Clinical Response in Rheumatoid Arthritis Patients Treated With Biologics at Approved Dosing Regimens

  Fang, Lanyan; Song, Xuyang; Ji, Ping; Wang, Yaning; Maynard, Janet; Yim, Sarah; Sahajwalla, Chandrahas; Xu, Mingjiang; Kim, Myong Jin; Zhao, Liang

• Novel Bioequivalence Approach for Narrow Therapeutic Index Drugs

  Yu, Lawrence; Jiang, Wenlei; Zhang, Xinyuan; Lionberger, Robert; Makhlouf, Fairouz; Schuirmann, Donald; Muldowney, Laurie; Chen, Meiling; Davit, Barbara; Conner, Dale; Woodcock, Janet

• 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

• Using Partial Area for Evaluation of Bioavailability and Bioequivalence

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

• 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

• 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