GDUFA Research Outcomes

BE Methods & Analyses

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.

• All(251)
• Posters(64)
• Presentations(67)
• Papers(120)

• Laser Directed Infrared (LDIR) Imaging to Track the Evolution of Polymorphic Transformation During Stability Studies on Ritonavir Tablets

  Zaker, Y; Yilmaz, H; Willett, D

• Laser Directed Infrared (LDIR) Imaging to Track the Evolution of Polymorphic Transformation During Stability Studies on Ritonavir Tablets

  Zaker, Y; Yilmaz, H; Willett, D

• Evaluation of Near Infrared (NIR) for the Quantification of Low Dose Drugs

  Krull, S; Ding ,T; Xu, X

• Impact of Risk Evaluation and Mitigation Strategy Programs on Product-Specific Guidance for Generic Drug Development

  Moore, A; Li, K; Shon, J; Kim, MJ; Nguyen, D

• 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

• 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

• 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

• 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

• Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

  Ren, Ping; Chan, Teresa; Yang, Wen-Cheng; Frost, Mitchell; Wang, Yan; Luke, Markham; Kim, Myong-Jin; Lionberger, Robert; Zhang, Yi

• Nitrosamine Mitigation: NDMA Impurity Formation and its Inhibition in Metformin Hydrochloride Tablets

  Shakleya, Diaa; Alayoubi, Alaadin; Brown, Dustin; Mokbel, Alaa; Abrigo, Nicolas; Mohammad, Adil; Wang, Jiang; Li, David; Shaklah, Maha; Alsharif, Fahd M; Desai, Saaniya; Essandoh, Martha; Faustino, Patrick J; Ashraf, Muhammad; O’connor, Thomas; Vera, Matthew; Raw, Andre; Sayeed, Vilayat; Keire, David A