Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes Lori McCaigSteven NowakLars Gruenig Commentary 14 March 2024 Article: 34
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution Eugenia Opolka-HoffmannMartin R. EdelmannRoland F. Staack Research Article Open access 13 March 2024 Article: 33
Quality by Design Framework Applied to GMMA Purification Carlo GiannelliFrancesca NecchiFrancesca Micoli Research Article Open access 08 March 2024 Article: 32
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework Jason H. WilliamsKai H. LiaoXu Meng Research Article Open access 07 March 2024 Article: 31
A Short Update on the Use of Monoclonal Antibodies in COVID-19 Antonio VitielloMichela SabbatucciAndrea Zovi Brief/Technical Note 05 March 2024 Article: 30
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data Shengjia WuHsueh-Yuan ChangDhaval K. Shah Research Article 05 March 2024 Article: 29
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA Lanyan FangYuqing GongLiang Zhao Meeting Report 27 February 2024 Article: 28
Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model Anas SaadeddinVivek PurohitKazuko Sagawa Correction Open access 21 February 2024 Article: 27
Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates Jie ChenLloyd Wei Tat TangLi Di Research Article 16 February 2024 Article: 26