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(183)
• Posters(28)
• Presentations(125)
• Papers(30)

• Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization

  Cheng, Yi-Hsien; Thomas, Sherin; Tsang, YC; Almeida, S; Ashraf, M; Fotaki, N; Heimbach, T; Patel, N; Shah, H; Jiang, X; Kim, MJ; Moody, R; Rostami-Hodjegan, A; Singh, R; Zhao, L; Babiskin, Andrew; Wu, F

• Addressing Degradation Challenges in BCS Class III Biowaiver Applications Through PBPK Modeling (Part II)

  Wu, Fang

• Pirana–Simcyp Virtual Bioequivalence (VBE) Workflow: Software Demonstration and Case Study on Paliperidone Palmitate Long-Acting Injectables.

  Craig, J; Morris, NM; McNally, K; Corpstein, C; Telaprolu, KC; Bogdanovich, P; Turner, DB; Rostami-Hodjegan, A; Jamei, M; and Bois, FY

• From In Vitro Dissolution Testing to In Vivo Clinical Pharmacokinetic Prediction Using PBPK Models for Oral Cavity Drug Products

  Plait, Fiona; Kalra, Priyata; Le Merdy, Maxime; Subhami, Saima; Lukacova, Viera; Dwivedi, Pankaj; Alam, Khondoker; Tsakalozou, Eleftheria; Pauletti, Giovanni; Zhou, Haiying

• Identification of Formulation Design Space for Quetiapine Fumarate Extended-release Tablets Across Strengths

  Li, Zekun; Yue, Weizhou; Johnson, Megan; Shen, Daniel; Allababidi, Saleh; Sun, Wei-Jhe; Nazzal, Sami; Al-ghabeish, Manar; Boyce, Heather; Wu, Fang; Zhang, Zhen; Delvadia, Renishkumar; Shen, Jie

• Pirana–Simcyp Virtual Bioequivalence (VBE) Workflow: Software Demonstration and Case Study on Paliperidone Palmitate Long-Acting Injectables

  Craig, J; Morris, NM; McNally, K; Corpstein, C; Telaprolu, KC; Bogdanovich, P; Turner, DB; Rostami-Hodjegan, A; Jamei, M; and Bois, FY

• Assessment of the Impact of Non-Comparable In Vitro Alcohol Dose Dumping Release on Systemic Exposure Using PBPK Absorption Modeling for Topiramate Extended-Release Capsules

  Cheng, Yi-Hsien; Wu, Fang; Mousa, Youssef; Zhao, Liang; Fang, Lanyan

• PBPK Modeling to Predict the Effect of Gastric pH on Bioequivalence of Palbociclib Tablets

  Jamil, Raqeeb; Babiskin, Andrew; Zhang, Lei; Fang, Lanyan; Wu, Fang

• PBPK Modeling to Support the Expansion of Biowaiver to Non-Q1/Q2 BCS Class III Drug Products

  Pal, Arindom; Ren, Ping; Zhang, Yi; Fang, Lanyan; Zhao, Liang; Wu, Fang

• Physiologically Based Biopharmaceutics Modeling for Virtual Bioequivalence Assessment of Metformin Immediate and Extended-Release Formulations

  Martins, Frederico; Vora, Tarang; Fraczkiewircz, Grace; Lukacova, Viera; Varanasi, Kanthikiran; Ribot, Olga; Gomez, Luis; Kanagasabapathy, Yuvaneshwari; Alam, Khondoker; Tsakalozou, Eleftheria; Wu, Fang; LeMerdy, Maxime