GDUFA Research Outcomes

PBPK Models

• All(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• Accelerating LAI Generic Development Using Model-Integrated Bioequivalence

  Gobburu, Joga

• In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple AnatomicallyCorrect Nasal Airway Models

  Golshahi, L; Manniello, M; Hosseini, S; Alfaifi, A; Schuman, T; Hindle, M; Longest, W; Sandell, D

• General Approach to the Safety Review of Pediatric Excipients

  Ghosh, Amrita

• A Model-Integrated Pathway to Explore Bioequivalence of LAI Products: Studies Using Paliperidone Palmitate

  Gajjar, Parmesh

• Industry Perspective: Incorporation of BE Modeling and LAI Development Challenges

  Fitzgerald, Michael

• Physiologically Based Pharmacokinetic Absorption Modeling to Support Bioequivalence Assessment for BCS Class III Drug Products

  Fang, Lanyan

• Leveraging Modeling and Simulation to Streamline Generic Drug Development and Assessment

  Fang, Lanyan

• Regulatory Applications and Research of Absorption Modeling for Pediatric Products

  Fang, Lanyan

• PK and Statistical Considerations for Steady State Bioequivalence Studies – FDA Perspective

  Fang, Lanyan (Lucy)

• In Vitro Evaluation of Regional Drug Deposition in Nasal Airways of Children Using Realistic Anatomical Replicas

  Esmaeili, A; Hosseini, S; Wilkins, J; Alfaifi, A; Dhapare, S; Walenga, R; Newman, B; Schuman, T; Edwards, D; Longest, W; Hindle, M; Golshahi, L