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)

• USP General Chapter Revision Process

  Marques, Margareth

• Requirements and Recommendations Related to Inactive Ingredients

  Mannion, Melissa

• FDA Responses to Questions on Q1/Q2 Sameness

  Mannion, Melissa

• Considerations for IVPT Data and Information Submitted in ANDAs

  Manerikar, Archana

• The In Vitro Permeation Test (IVPT): Historical Perspective, Current Context, and Future Directions

  Maibach, Howard

• Specificity and Discriminatory Challenges Leading to Limitation in Accurate Complete Identification and Quantification of Excipients in RLS Deformulation

  Mallick, Babita

• Considerations for IVRT Data and Information Submitted in ANDAs

  Ma, Tien

• Building Mechanistic IVIVC

  Lukacova, Viera

• Case Study: Predicting Regional Lung Deposition of Pharmaceutical Aerosols with CFD

  Longest, Worth; Dutta, Rabijit

• Modeling Complex Particle Interactions in Dry Powder Inhaler

  Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran