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(360)
• Posters(77)
• Presentations(193)
• Papers(90)

• Impact of Food and Formulation on Bioequivalence: A Generic Industry Perspective

  Kumar, Anita

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, A; Golshahi, L; Longest, W

• Industry Perspective: Regulatory Challenges in Development of Generic Long-Acting Injectables

  Kohojkar, Ameya

• Formulation Considerations for Selecting an Appropriate RLD or RS

  Kim, Timothy H

• Best Practices for Submitting Formulation Assessment Requests and Avoiding Information Requests: Tips for Submitting a Proposed Formulation Table

  Kim, Elizabeth

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

  Kelly, Marc

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef

• Modeling for Success: A Case Example for Oseltamivir Phosphate

  Mousa, Youssef

• 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