GDUFA Research Outcomes

PBPK Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.

• All(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• FDA Recommendations for Alternative Bioequivalence Approaches: Design, Validation, and Use Case for In Silico Studies

  Walenga, Ross

• Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate

  Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, Lanyan (Lucy); Liang, Zhao

• Modeling and Simulation to Support Development and Approval of Generic Orally Inhaled Drug Products

  Walenga, Ross

• Application and Validation of Mechanistic Modeling for Generic Drug Products at the U.S. Food and Drug Administration (FDA)

  Walenga, Ross; Tan, Ming-Lian; Wu, Fang

• Complex Nasal Suspensions: Utilization of In Silico Studies to Support Development and Approval

  Walenga, Ross

• Utilizing In Vitro and In Silico Methods to Accelerate Product Development for Generic Nasal Drug Products

  Walenga, Ross

• Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products

  Walenga, Ross

• Modeling of CNS Delivery for Nose-to-Brain Targeted Drug Products

  Walenga, Ross

• Abbreviated New Drug Application (ANDA) and Pre-ANDA Experience with Orally Inhaled Drug Product (OIDP) Modeling

  Walenga, Ross

• ANDA and Pre-ANDA Experience with OIDP Modeling

  Walenga, Ross