GDUFA Research Outcomes

QCP Methods

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to quantitative clinical pharmacology assessments of oral absorption to support generic product development and assessment.

• All(159)
• Posters(46)
• Presentations(74)
• Papers(39)

• 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

• Beyond Particle Size: Impact of Milling Techniques on Agglomeration Behavior and In Vitro Performance of Long-Acting Injectable Suspensions

  Bhorkade, Saurabh; Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Wang, Yan; Burgess, Diane J

• Population Balance Modeling of Aggregation in Long-Acting Injectable Formulations Integrated with PBPK Modeling

  Mullin, James M; Silva, Daniela; Alam, Khondoker; Al Shoyaib, Abdullah

• 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 Repeated Crossover Bioequivalence Design Under Steady State Conditions

  Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaofei; Babiskin, Andrew; Yoon, Miyoung; Zhao, Liang; Fang, Lanyan

• Model-Integrated Bioequivalence Method for Highly Variable Drugs with Long Half-Life: a Simulation Study Comparing Complete Washout and Incomplete Washout Designs

  Huang, Zhe; Chen, Xiaomei; Donnelly, Mark; Fang, Lanyan; Zhao, Liang; Karlsson, Mats O; Hooker, AC

• Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions

  Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaolei; Babiskin, Andrew

• Performance of Machine Learning Algorithms for Model Selection

  Li, Xinnong; Sale, Mark; Nieforth, Keith; Craig, James; Wang, Fenggong; Solit, David; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang

• Swallowability of Solid Oral Drug Products in Regulatory Submissions: Patient-Specific Features, Product Physical Attributes, and Clinical Swallowability Study Designs

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

• Development of an In Vitro Release Testing Method for Vaginal Creams

  Yue, Weizhou; Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam; Shen, Jie