GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

  Pal, Arindom; Wu, Fang; Walenga, Ross; Tsakalozou, Eleftheria; Alam, Khondoker; Gong, Yuqing; Liang, Zhao; Fang, Lanyan

• Using Mechanistic Modeling Approaches to Support BE Assessments for Oral Products

  Wu, Fang; Mousa, Youssef; Jereb, Rebeka; Batchelor, Hannah; Chakraborty, Sumon; Heimbach, Tycho; Stier, Ethan; Kesisoglou, Filippos; Kollipara, Sivacharan; Zhang, Lei; Zhao, Liang

• In Vitro Lipolysis Model to Predict Food Effect of Poorly Water-Soluble Drugs Itraconazole, Rivaroxaban, and Ritonavir

  Patel, Roshni P; Cristofoletti, Rodrigo; Wu, Fang; Al Shoyaib, Abdullah

• Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances

  Lu, Dongmei; Rege, Bhagwant; Rawlings, Kimberly; Yang, Jingyue; Alam, Khondoker; Bode, C; Zhao, Liang; Faustino, Patrick; Wu, Fang; Shakleya, Diaa; Nickum, Elisa; Li, Bing; Wang, Rong; Stier, Ethan; Miezeiewski, Blair; Patel, Rachana; Boam, Ashley; Lionberger, Robert; Keire, D; Yu, Lawrence

• Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value

  Coutinho, Ana; Cristofoletti, Rodrigo; Wu, Fang; Al Shoyaib, Abdullah; Dressman, Jennifer; Polli, James E

• Regulatory Utility of Physiologically Based Pharmacokinetic Modeling for Assessing Food Impact in Bioequivalence Studies: A Workshop Summary Report

  Al Shoyaib, Abdullah; Riedmaier, Arian Emami; Kumar, Anita; Roy, Partha; Parrott, Neil; Fang, Lanyan; Tampal, Nilufer; Yang, Yuching; Jereb, Rebeka; Zhao, Liang; Wu, Fang

• A Robust, Viable, and Resource Sparing HPLC-based logP Method Applied to Common Drugs

  Coutinho, Ana; Cristofoletti, Rodrigo; Wu, Fang; Shoyaib, Abdullah; Dressman, Jennifer; Polli, James

• Regulatory Utility of Physiologically Based Pharmacokinetic Modeling to Support Alternative Bioequivalence Approaches and Risk Assessment: A Workshop Summary Report

  Wu, F; Mousa, Y; Raines, K; Bode, C; Tsang, YC; Cristofoletti, R; Zhang, H; Heimbach, T; Fang, L; Kesisoglou, F; Mitra, A; Polli, J; Kim, MJ; Fan, J; Zolnik, BS; Sun, D; Zhang, Y; Zhao, L

• Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study

  Pawar, Gopal; Wu, Fang; Zhao, Liang; Fang, Lanyan; Burckart, Gilbert; Feng, Kairui; Mousa, Youssef; Al Shoyaib, Abdullah; Jones, Marie-Christine; Batchelor, Hannah

• Increasing Impact of Quantitative Methods and Modeling in Establishment of Bioequivalence and Characterization of Drug Delivery

  Yoon, Miyoung; Babiskin, Andrew; Hu, Meng; Wu, Fang; Raney, Sam G.; Fang, Lanyan; Zhao, Liang