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Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration Garima ThakurVishnu MasampallyAnurag S. Rathore Research Article 13 July 2022 Article: 83
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes Adam J. RishSamuel R. HensonCarl A. Anderson Research Article 12 July 2022 Article: 82
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium Marta Starcevic ManningMohamed HassaneinViswanath Devanarayan Research Article Open access 12 July 2022 Article: 81
A Simulation Study of the Comparative Performance of Partial Area under the Curve (pAUC) and Partial Area under the Effect Curve (pAUEC) Metrics in Crossover Versus Replicated Crossover Bioequivalence Studies for Concerta and Ritalin LA Andre J. JacksonHenry C. Foehl Research Article 08 July 2022 Article: 80
Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective Ruo-Jing LiLian MaYaning Wang Regulatory Note 06 July 2022 Article: 79
Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay Michael A. PartridgeJihua ChenGiane Sumner Research Article Open access 01 July 2022 Article: 78
Pharmacokinetics of Gentamicin Components C1, C1a, and C2/C2a/C2b and Subsequent Decline in Glomerular Filtration Rate in Neonates Hiie SoeorgHelgi PadariTuuli Metsvaht Research Article 27 June 2022 Article: 77
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy Susan C. IrvinAmanda D’OrvilliersMichael A. Partridge Research Article Open access 21 June 2022 Article: 76
Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures Sankar RenuMary Shank-RetzlaffPravansu Mohanty Research Article Open access 16 June 2022 Article: 75
Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review Brigitta NagyDorián László GalataZsombor Kristóf Nagy Review Article Open access 14 June 2022 Article: 74
Joint Disposition Properties and Comprehensive Pharmacokinetic Characterization of Antibody–Drug Conjugates Kai H. LiaoJason H. WilliamsXu Meng Research Article Open access 10 June 2022 Article: 73
Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy Katherine L. GillHannah M. Jones Review Article Open access 01 June 2022 Article: 72
Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters Keumhan NohEdwin C. Y. ChowK. Sandy Pang Review Article 01 June 2022 Article: 71
Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study Bing YaoXiao GaoGuoguang Chen Research Article 27 May 2022 Article: 70
Correction: Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration Hsueh-Yuan ChangShengjia WuDhaval K. Shah Correction 24 May 2022 Article: 69