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)

• Exploring the Relationship Between the In Vitro Properties and the Pharmacokinetic Parameters of Advair Diskus

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Joga

• Exploration the Potential Impact of Batch-to-Batch Variability of Inhalation Powder Drug Products on Pharmacokinetic Bioequivalence Study Power

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Joga

• 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

• The Effect of PLGA Molecular Weight on Drug Release from Microspheres

  Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane

• Quantitative Assessment of Additional Metrics in the Bioequivalence Evaluation of Oxcarbazepine Extended-Release Tablet

  Kim, Hyewon; Fang, Lanyan; Zhao, Liang

• Model-Based Tests of Bioequivalence: Impact of a Model Misspecification

  Guhl, Melanie; Mercier, F; Sharan, Satish; Feng, Kairui; Sun, G; Sun, W; Grosser, S; Zhao, Liang; Fang, Lanyan; Mentre, F; Comets, E; Bertrand, J

• Clinical Practice Data To Aid Narrow Therapeutic Index Drug Classification: Lamotrigine

  Guptill, Jeffrey; Wu, Huali; Greenberg, Rachel; Gostelow, Martyn; Gonzalez, Daniel; Hornik, Christoph; Zheng, Nan; Jiang, Wenlei; Cohen-Wolkowiez, Michael; Hill, Kevin

• Model-Based Tests of Bioequivalence: Impact of a Model Misspecification

  Guhl, Melanie; Mercier, F; Sharan, Satish; Feng, Kairui; Sun, G; Sun, W; Grosser, S; Zhao, Liang; Fang, Lanyan; Mentre, F; Comets, E; Bertrand, J

• Age Is a Statistically Significant Predictor of the Within Subject Variability in Dabigatran Pharmacokinetics

  Gonzalez-Sales, Mario; Fan, Jianghong; Fang, Lanyan; Hu, Meng; Lionberger, Robert; Zhao, Liang

• Model Based Exposure-Response Analysis of Rivaroxaban to Assess the Adequacy of Current Bioequivalence Limits in Generic New Oral Anticoagulant Drugs

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