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.
-
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
-
In Vivo Relevance of Dissolution
Jiang, Wenlei
-
Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment
Jiang, Wenlei
-
Overview of Complex Generics Regulatory Perspective on Bioequivalence
Jiang, Jeff
-
PBPK Modeling to Support Risk Assessment for Oral Drug Products, Including Waiver of Fed BE Studies
Jereb, Rebeka
-
PBPK Modeling for Different Locally-Administered Drug Products
Jereb, Rebeka
-
Establishing Bioequivalence Using Characterization Based Approaches for Topical Products – Challenges & Solutions
Jani, Romit
-
Use of PBPK in New Drug Development and Regulatory Review – Clinical Pharmacology Perspective
Huang, Shiew-Mei