GDUFA Research Outcomes

Vaginal Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the vaginal route, including vaginal gels and creams.

• All(24)
• Posters(5)
• Presentations(16)
• Papers(3)

• Challenges Associated with Development of Generic PLGAPLA Based Drug Products

  Wang, Yan

• Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing

  Manna, Soumyarwit

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

• Development of Model-Informed Bioequivalence Evaluation Strategies for Long-Acting Injectable Products (LAI)

  Karlsson, Matt; Chen, Xiaomei; Hooker, Andrew

• Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives

  Jiang, Wenlei

• An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• Model-informed Drug Development for Long-acting Injectable Products

  Fang, Lanyan (Lucy)

• User Friendly Tools for Population PK and PBPK modeling

  Bies, Robert S

• PBPK Modeling Approaches to the Female Reproductive Tract

  Bies, Robert

• Physiologically Based Pharmacokinetic (PBPK) Model of Drug Delivery in the Female Reproductive Tract

  Li, Xinnong; Straubinger, Thomas; Valicherla, Guru R; Zhang, Zhongfang; Achilles, Sharon L; Donnelly, Mark; Zhao, Liang; Tsakalozou, Eleftheria; Chen, Beatrice A; Rohan, Lisa; Bies, Robert