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(475)
• Posters(107)
• Presentations(231)
• Papers(137)

• Formulation Considerations for Selecting an Appropriate RLD or RS

  Kim, Timothy H

• Utilizing Modelling Approaches to Support Regulatory Submission for Orally Inhaled Drug Products: Case Example

  Kelly, Marc

• General Considerations for the Quantitative Sameness Evaluation of a Proposed Generic Formulation

  Kaviratna, Anubhav

• Key Aspects in Developing Appropriate IVRT Methods for Topical Generic Products: Advances and Challenges

  Kapanadze, Theo

• A Multiscale Framework For Computational Inhalation Pharmacology

  Kannan, Ravi; Chen, Z J; Singh, Narendra; Przekwas, Andrzekj; Delvadia, Renishkumar; Tian, Geng

• Prediction of Respimat� Inhaler Spray: Co-Flow Air Behavior

  Kakhi, Maziar

• PBPK Models: Opportunities for Enhancements

  Jusko, William

• Overview of Complex Generics Regulatory Perspective on Bioequivalence

  Jiang, Jeff

• PBPK Modeling to Support Risk Assessment for Oral Drug Products, Including Waiver of Fed BE Studies

  Jereb, Rebeka

• PBPK Modeling for Different Locally-Administered Drug Products

  Jereb, Rebeka