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)

• IVPT Studies with Sunscreen Products: Experimental Parameters

  Yang, Yang

• Using PBPK Model to Support Risk Assessment for Oral Products, from a Regulatory Perspective

  Wu, Fang

• Discussion with EMA PKWG and CVSWP: Levothyroxine NTI classification and BE Approach

  Donnelly, Michael; Fang, Lanyan(Lucy)

• Using Physiologically-Based Pharmacokinetic Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver

  Wu, Fang

• Application of PBPK Modeling in Regulatory Submission: FDA Experience on Generic Drugs

  Wu, Fang

• Considerations for the Qualitative Sameness Evaluation of a Proposed Generic Formulation

  Wang, Yan

• 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

• ANDA and Pre-ANDA Experience with OIDP Modeling

  Walenga, Ross

• In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development

  Walenga, Ross