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)

• Using Modeling and Simulation to Correct Carryover for Long Half-Life Drug with Incomplete Washout

  Ozdin, Deniz; Chung, Min Tzu

• Considerations of Bioequivalence Studies for Long-Acting Injectables and the Application of Model-Integrated Evidence Approaches

  Gong, Yuqing

• Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use

  Fang, Lanyan (Lucy)

• Enabling the Conduct of Patient Pharmacokinetics Bioequivalence Studies Using Model-Integrated Evidence

  Gong, Yuqing

• Model Master File: How to Develop and Submit One?

  Tsakalozou, Eleftheria

• Controlled Correspondence on Clinical Pharmacology Topics in Generic Drug Development

  Donnelly, Mark

• Introduction and Overview of the Model Master File

  Fang, Lanyan

• 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