GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• Physiologically Based Pharmacokinetic Modeling for BCS IV Drugs and Case Examples

  Wu, Fang

• Physiologically Based Pharmacokinetic Absorption Modeling to Support BCS-Based Waiver of In Vivo Bioequivalence Studies

  Wu, Fang

• Totality of Evidence Including PBPK Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets (Part II)

  Wu, Fang

• Regulatory Perspective of Model Master Files Utilities for Oral Drug Products

  Wu, Fang

• Using Physiologically Based Pharmacokinetic Absorption Modeling for Bioequivalence Evaluation in Adult and Pediatric Populations

  Wu, Fang

• Advances on Using PBPK Modeling to Support BE Assessment for Oral Products

  Wu, Fang

• PBPK Modeling for Setting PSD Specifications

  Wu, Fang

• OGD Perspectives on PBBM Applications for Generics

  Wu, Fang

• Using Physiologically Based Pharmacokinetic Absorption Modeling for Bioequivalence Evaluation in Adult and Pediatric Populations

  Wu, Fang

• A Critical Overview of the Biological Effects of Excipients

  Wu, Fang; Tsakalozou, Eleftheria