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)

• Development of Methods for Evaluation of Formulation Differences and their Impact on Therapeutic Equivalence: Broadening the Therapeutic Scope

  Mohammed, Yousuf

• Modeling to Support Regulatory Needs of OIDPs

  Mohamed, Raja

• Model-based Statistical Approaches for Pharmacokinetic Bioequivalence Studies with Sparse Sampling and Extension to Two-stage Designs

  Mentre, France; Loingeville, Florence; Rakez, Manel; Nguyen, Thu Thuy; Bertrant, Julie; Mollenhoff, Kathrin; Dette, Holger; Sharan, Satish; Sun, Guoying; Grosser, Stella; Zhao, Liang; Fang, Lanyan

• USP General Chapter Revision Process

  Marques, Margareth

• FDA Responses to Questions on Q1/Q2 Sameness

  Mannion, Melissa

• Requirements and Recommendations Related to Inactive Ingredients

  Mannion, Melissa

• Considerations for IVPT Data and Information Submitted in ANDAs

  Manerikar, Archana

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

  Mallick, Babita

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

  Maibach, Howard

• Considerations for IVRT Data and Information Submitted in ANDAs

  Ma, Tien