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.
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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
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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
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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
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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
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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
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PBPK Modeling to Predict the Effect of Gastric pH on Bioequivalence of Palbociclib Tablets
Jamil, Raqeeb; Babiskin, Andrew; Zhang, Lei; Fang, Lanyan; Wu, Fang
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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
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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
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Physiologically Based Pharmacokinetic (PBPK) Oral Absorption Model to Predict Mucosal Permeability of Oral Cavity Drug Products
Kalra, Priyata; Le Merdy, Maxime; Lukacova, V; Dwivedi, Pankaj; Alam, K; Tsakalozou, Eleftheria; Pauletti, G; Zhou, Haiying
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Utilizing PBPK Absorption Modeling to Evaluate Impact of Single-Sex on Bioequivalence Evaluation of Atorvastatin Immediate Release Tablets
Cheng, Yi Hsien; Wu, Fang; Zhao, Liang; Fang, Lanyan (Lucy)