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(159)
• Posters(46)
• Presentations(74)
• Papers(39)

• A Proposal for Alternative FDA Bioequivalence Criteria for Narrow Therapeutic Index Drug Products to Support Future Harmonization

  Sun, Wanjie; Schuirmann, Donald; Makhlouf, Fairouz; Donnelly, Mark; Jiang, Wenlei; Zhang, Hongling; Mehta, Mehul U; Zhang, Lei; Tampal, Nilufer; Grosser, Stella

• Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches

  Fang, Lanyan; Tsakalozou, Eleftheria; Polli, James

• Model-based Approach for Two-Stage group sequential or adaptive designs in bioequivalence studies using parallel and crossover designs

  Loingeville, F; Rakez, M; Thuy Nguyen, T; Donnelly, M; Fang, L; Feng, K; Zhao, L; Grosser, S; Sun, G; Sun, W; Mentré, F; Bertrand, J

• Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use

  Fang, Lanyan; Tsakalozou, Eleftheria; Wu, Fang; Ritterbeck, Daniel; Zhao, Liang; Zhang, Lei; Lionberger, Robert

• Considering Opportunities and Challenges When Implementing the Model Master File Framework – a Meeting Report

  Tsakalozou, Eleftheria; Fang, Lanyan; Skoda, Erin; Nicholas, Timothy; Kollipara, Sivacharan; Ren, Ke; Grosser, Stella; Rege, Bhagwant; Roy, Partha; Zhu, Hao; Zhao, Liang

• A 2024 Update on US FDA Implementation of Partial Area Under the Curve into Bioavailability and Bioequivalence Assessments

  Hopefl, Robert; Gong, Yuqing; Bielski, Elizabeth; Pillai, Venkateswaran C; Newman, Bryan; Qin, Bin; Wang, Yan; Yoon, Miyoung; Zhang, Qiangnan; Stier, Ethan; Uppoor, Ramana; Zhu, Hao; Zhang, Lei; Fang, Lanyan

• Leveraging Model Master Files for Long-Acting Injectables

  Gong, Yuqing; Hopefl, Robert; Li, Tonglei; Hooker, Andrew C; Silva, Daniela Amaral; Alam, Khondoker; Ducharme, Murray; Moody, Rebecca; Saha, Pratik; Babiskin, Andrew

• Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations

  Donnelly, Mark; Fang, Lanyan; Madabushi, Rajanikanth; Zhu, Hao; Luke, Markham C; Canterbury, Crystal; Lerman, Bruce; Kaur, Paramjeet; Patel, Devvrat; Sun, Wanjie; Schuirmann, Don; Dinsmore, Steven; Mehta, Mehul; Zhao, Liang

• Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability

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

• Commentary on ���Exploration of Suitable Pharmacodynamic Parameters for Acarbose Bioequivalence Evaluation: a Series of Clinical Trials with Branded Acarbose�۪ by Jie Huang et al

  Zhang, Peijue; Lee, Jieon; Feng, Kairui; Babiskin, Andrew; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang