GDUFA Research Outcomes
PBPK Models
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Formulation Drug Product Quality Attributes Additions in Dermal PBPK Model
Babiskin, Andrew
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Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products
Alam, Khondoker
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Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges
Andre, Kris
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Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2
Arora, Sumit
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Excipient Safety Assessment in Generic Drug Formulations: An Overview
Agarwal, Stuti
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Expectations and Common Deficiencies for IVRT Studies Submitted in ANDAs for Ophthalmic Emulsion Products
Abuznait, Alaa
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Mechanistic Modeling of Intramuscular Administration of Long-acting Injectable Suspensions Accounting for Fibrosis at the Depot Site
Silva, Daniela Amaral; Malavia, Nilesh; Burgess, Daine J; Khondoker, Alam; Wang, Yan; Lukacova, Viera
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In Silico Predictive Modeling of the Pharmacokinetic (PK) Profiles of Nasal Sprays in Adults and Children
Kaviratna, Anubhav; Mohan, Abhinav R; Newman, Bryan; Walenga, Ross; Dutta, Rabijit; Kolanjiyil, Arun; Longest, P Worth; Golshahi, Laleh
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Enabling Formulation Development of LAIs Thorough Understanding Critical Formulation Parameters
Malavia, Nilesh; Bao, Quanying; Silva, Daniela; Lukacova, Viera; Alam, Khondoker; Wang, Yan; Burgess, Diane
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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