GDUFA Research Outcomes

QCP Methods

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

• Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions

  Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaofei; Babiskin, Andrew; Yoon, Miyoung; Zhao, Liang; Fang, Lanyan

• Model-Integrated Bioequivalence Method for Highly Variable Drugs with Long Half-Life: a Simulation Study Comparing Complete Washout and Incomplete Washout Designs

  Huang, Zhe; Chen, Xiaomei; Donnelly, Mark; Fang, Lanyan; Zhao, Liang; Karlsson, Mats O; Hooker, AC

• Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions

  Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaolei; Babiskin, Andrew

• Performance of Machine Learning Algorithms for Model Selection

  Li, Xinnong; Sale, Mark; Nieforth, Keith; Craig, James; Wang, Fenggong; Solit, David; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang

• Swallowability of Solid Oral Drug Products in Regulatory Submissions: Patient-Specific Features, Product Physical Attributes, and Clinical Swallowability Study Designs

  Mcguire, Meredith; Mostofa, Agm; Shon, Jihong; Frost, Mitchell; Kim, Myong Jin; Li, Karen

• Development of an In Vitro Release Testing Method for Vaginal Creams

  Yue, Weizhou; Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam; Shen, Jie

• Development of An In Vitro Permeation Test Method for Rectal Suppositories

  Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam; Shen, Jie

• Using Partial AUC to Characterize the Impact of Shape of Pharmacokinetic Profiles on Bioequivalence Evaluation

  Das, Sharmila; Wu, Fang; Fang, Lanyan; Polli, James

• Determination of CYP2D6 Phenotyping for Metoprolol using CYP2D6 Genotype-derived Activity Score: Results from a Prospective, Clinical Trial

  Thomas, C D; Monsely, S A; El Rouby, N; Kim, S; Lingineni, K; Langaee, T; Langaee, T; Gong, Y; Johnson, J A; Schmidit, S O; Fyre, R F; Cavallari, L H

• Evaluation of Model-Based Bioequivalence approach for one single sample pharmacokinetic studies

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