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)

• 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

• 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

• 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

• 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