
Volume 24, issue 4, July 2022
16 articles in this issue
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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
Authors (first, second and last of 4)
- Garima Thakur
- Vishnu Masampally
- Anurag S. Rathore
- Content type: Research Article
- Published: 13 July 2022
- Article: 83
This is part of 1 collection: -
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes
Authors (first, second and last of 6)
- Adam J. Rish
- Samuel R. Henson
- Carl A. Anderson
- Content type: Research Article
- Published: 12 July 2022
- Article: 82
This is part of 1 collection: -
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium
Authors (first, second and last of 13)
- Marta Starcevic Manning
- Mohamed Hassanein
- Viswanath Devanarayan
- Content type: Research Article
- Open Access
- Published: 12 July 2022
- Article: 81
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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
Authors
- Andre J. Jackson
- Henry C. Foehl
- Content type: Research Article
- Published: 08 July 2022
- Article: 80
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Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective
Authors (first, second and last of 10)
- Ruo-Jing Li
- Lian Ma
- Yaning Wang
- Content type: Regulatory Note
- Published: 06 July 2022
- Article: 79
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Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay
Authors (first, second and last of 14)
- Michael A. Partridge
- Jihua Chen
- Giane Sumner
- Content type: Research Article
- Open Access
- Published: 01 July 2022
- Article: 78
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Pharmacokinetics of Gentamicin Components C1, C1a, and C2/C2a/C2b and Subsequent Decline in Glomerular Filtration Rate in Neonates
Authors (first, second and last of 6)
- Hiie Soeorg
- Helgi Padari
- Tuuli Metsvaht
- Content type: Research Article
- Published: 27 June 2022
- Article: 77
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Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy
Authors (first, second and last of 13)
- Susan C. Irvin
- Amanda D’Orvilliers
- Michael A. Partridge
- Content type: Research Article
- Open Access
- Published: 21 June 2022
- Article: 76
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Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures
Authors (first, second and last of 5)
- Sankar Renu
- Mary Shank-Retzlaff
- Pravansu Mohanty
- Content type: Research Article
- Open Access
- Published: 16 June 2022
- Article: 75
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Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review
Authors (first, second and last of 4)
- Brigitta Nagy
- Dorián László Galata
- Zsombor Kristóf Nagy
- Content type: Review Article
- Open Access
- Published: 14 June 2022
- Article: 74
This is part of 1 collection: -
Joint Disposition Properties and Comprehensive Pharmacokinetic Characterization of Antibody–Drug Conjugates
Authors (first, second and last of 5)
- Kai H. Liao
- Jason H. Williams
- Xu Meng
- Content type: Research Article
- Open Access
- Published: 10 June 2022
- Article: 73
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Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy
Authors
- Katherine L. Gill
- Hannah M. Jones
- Content type: Review Article
- Open Access
- Published: 01 June 2022
- Article: 72
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Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters
Authors (first, second and last of 6)
- Keumhan Noh
- Edwin C. Y. Chow
- K. Sandy Pang
- Content type: Review Article
- Published: 01 June 2022
- Article: 71
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Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study
Authors (first, second and last of 10)
- Bing Yao
- Xiao Gao
- Guoguang Chen
- Content type: Research Article
- Published: 27 May 2022
- Article: 70
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Correction: Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration
Authors (first, second and last of 6)
- Hsueh-Yuan Chang
- Shengjia Wu
- Dhaval K. Shah
- Content type: Correction
- Published: 24 May 2022
- Article: 69