GDUFA Research Outcomes
PBPK Models
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Current Scientific Considerations in Modeling for In Vitro BE of Topically Administered Ophthalmics
Chandran, Sajeev
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Use of Mechanistic Modelling to Determine the Sensitivity of in vitro CQAs to Regional Lung Deposition and Predict PK for OIDPs
Butler, Clare
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Studies to Further Establish PK as Central Tool for a Streamlined Approval of Generic Inhalation Drugs
Bulitta, Jurgen; Hochhaus, Gunther
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Developing PBPK for Ocular Delivery
Bolger, Michael
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User Friendly Tools for Population PK and PBPK modeling
Bies, Robert S
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PBPK Modeling Approaches to the Female Reproductive Tract
Bies, Robert
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Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products
Bielski, Elizabeth
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Scientific Challenges Related to Establishing Q1/Q2 Sameness-An Industry Perspective
Zhao, Liang
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IVPT Studies with Sunscreen Products: Potential Regulatory Utility
Hakeem, Susan
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Relevant Challenges with IVRT with Iron-Carbohydrate Complexes: Application to IVIVC Models
Hartka, Kathryn