GDUFA Research Outcomes

BE Methods & Analyses

• All(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• 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

• 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

• 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

• Changes in Drug Crystallinity in a Commercial Tacrolimus Amorphous Formulation Result in Variable Pharmacokinetics

  Taylor, LS; Trasi, Niraj; Purohit, HS; Sun, D; Kinjo, Minori; Ni, Zhanglin; Mahjabeen, Sanjida; Feng, Karui Kevin; Sun, Wei-Jhe; Matta, Murali K; Decker, Brian; Galinsky, Raymond E

• 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

• Designs of Clinical Swallowability Assessments of Solid Oral Dosage Forms in Regulatory Submissions

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

• The Effect of Food Vehicles on In Vitro Performance of Pantoprazole Sodium Delayed Release Sprinkle Formulation

  Wu, Kai-Wei; Zheng, Kai; Tian, Li; Xia, Li; Hwang, Sung Yong; Nwakama, Patrick E; Sun, Wei Jhe; Kim, Myong Jin; Tampal, N; Xu, Xiaoming; Boyce, Heather; Feng, Xin

• 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