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The AAPS Journal|September 28, 2022
NIR Spectroscopy as an Online PAT Tool for a Narrow Therapeutic Index Drug: Toward a Platform Approach Across Lab and Pilot Scales for Development of a Powder Blending Monitoring Method and Endpoint DeterminationSameer Talwar, Pallavi Pawar, Huiquan Wu, et al.
The AAPS Journal|October 20, 2022
Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain ResilienceMatt Fellows, Thomas Friedli, Ye Li, et al.
The AAPS Journal|October 20, 2022
Risk Factors, Hyaluronidase Expression, and Clinical Immunogenicity of Recombinant Human Hyaluronidase PH20, an Enzyme Enabling Subcutaneous Drug AdministrationMarie A Printz, Barry J Sugarman, Rudolph D Paladini, et al.
The AAPS Journal|December 22, 2023
Design, Synthesis, and Biochemical Analysis of a Molecule Designed to Enhance Endosomal EscapeSatish G Jadhav, Ryan L Setten, Carlos Medina, et al.
The AAPS Journal|December 12, 2023
Pharmacodynamics of Cyclin D1 Degradation in Ovarian Cancer Xenografts with Repeated Oral SHetA2 DosingAnkur Sharma, Xin Liu, Vishal Chandra, et al.
The AAPS Journal|December 19, 2023
Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19Michelle Stafford, Rachel Linck Dunn, Nirzari Gupta, et al.
The AAPS Journal|January 24, 2024
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral ProductsFang Wu, Youssef Mousa, Rebeka Jereb, et al.
The AAPS Journal|July 23, 2024
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013-2022Erica L Friedman, Leah W Falade, Michael G Bartlett
The AAPS Journal|July 23, 2024
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid DissociationCarley Karsten, Karin Grannas, Oskar Bergman, et al.
The AAPS Journal|August 22, 2024
Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical ApplicationsStacey Marden, John M Campbell, Neal Adams, et al.
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