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The AAPS Journal|April 29, 2025
Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of IberdomideCaroline Sychterz, Ping Chen, Ajay Saxena, et al.
The AAPS Journal|October 1, 2025
Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and SimulationMaxime Le Merdy, Ming-Liang Tan, Viera Lukacova
The AAPS Journal|October 6, 2025
Cut Point in Immunogenicity Testing: A Flawed Concept We Can Live WithoutRobert J Kubiak
The AAPS Journal|August 19, 2025
Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug DevelopmentShefali Patel, Mike Baratta, Peter Bryan, et al.
The AAPS Journal|August 19, 2025
Beyond Accuracy, Precision and TAE: Direct assay Validation Against Product Specification Aligned with USPDavor Josipovic
The AAPS Journal|August 11, 2025
Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug ProductsPing Ji, William M Boyd, Chandrahas Sahajwalla
The AAPS Journal|August 13, 2025
Optimization of In Vitro CYP3A4 TDI Assay Conditions and Use of Derived Parameters for Clinical DDI Risk Assessment Using Static and Dynamic ModelsAlessandra Pugliano, Aynur Ekiciler, Lena Preiss, et al.
The AAPS Journal|August 13, 2025
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone AssaysMichael A Partridge, Lynn Kamen, Bonnie Wu, et al.
The AAPS Journal|February 10, 2026
A Data-driven Stepwise Approach to Cross Validation of Clinical Anti-Drug Antibody (ADA) AssaysSally Ye, Yan Mao, Kelly Coble
The AAPS Journal|February 10, 2026
Utility of Modeling and Simulations in Drug Development: Contrasting Japan, US and UK Descriptions of PBPK Modeling from Package InsertsShinji Kudo, Hirokazu Wakuda, Ichiro Oikawa, et al.
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