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)

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

  Kelly, Marc

• 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

• PBPK Models: Opportunities for Enhancements

  Jusko, William

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei

• Overview of Complex Generics Regulatory Perspective on Bioequivalence

  Jiang, Jeff

• In Vivo Relevance of Dissolution

  Jiang, Wenlei

• Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment

  Jiang, Wenlei

• PBPK Modeling for Different Locally-Administered Drug Products

  Jereb, Rebeka

• PBPK Modeling to Support Risk Assessment for Oral Drug Products, Including Waiver of Fed BE Studies

  Jereb, Rebeka