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Molecular Pharmaceutics|February 23, 2021
Evaluation of the Physicochemical Properties of the Iron Nanoparticle Drug Products: Brand and Generic Sodium Ferric GluconateJoel E P Brandis, Kyle C Kihn, Marc B Taraban, et al.
The AAPS Journal|August 6, 2008
Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyondJames E Polli, Bertil S I Abrahamsson, Lawrence X Yu, et al.
Molecular Pharmaceutics|April 29, 2025
Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory SubmissionsSumit Arora, Xavier Pepin, Masoud Jamei, et al.
Molecular Pharmaceutics|July 1, 2024
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary ReportXavier Pepin, Sumit Arora, Luiza Borges, et al.
Molecular Pharmaceutics|September 30, 2024
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary ReportTycho Heimbach, Flora Musuamba Tshinanu, Kimberly Raines, et al.
The AAPS Journal|November 7, 2023
Drug Dissolution in Oral Drug Absorption: Workshop ReportKimberly Raines, Payal Agarwal, Patrick Augustijns, et al.
The AAPS Journal|February 12, 2026
Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug ProductsJennifer K Lee, Ha-Na Lee, Sudhir Agrawal, et al.
AAPS Open|April 23, 2026
Mastering particle size analysis: lessons, challenges, and future directions from the FDA-CRCG workshopXiaoming Xu, William C Smith, James E Polli, et al.
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