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Based on whole-exome sequencing to explore the rule of Herceptin and TKI resistance in breast cancer patients
BackgroundBreast cancer is the second leading cause of cancer-related death in women, and drug resistance during treatment is a major challenge....
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A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin®) in Healthy Chinese Adults
Background and ObjectiveGB221 is a recombinant humanized anti-HER2 monoclonal antibody. The purpose of this study was to evaluate the...
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A randomized, double-blind, phase III, non-inferiority clinical trial comparing the efficacy and safety of TA4415V (a proposed Trastuzumab biosimilar) and Herceptin (Trastuzumab reference product) in HER2-positive early-stage breast Cancer patients
BackgroundThis study compared efficacy and safety of TA4415V, a trastuzumab biosimilar, with reference trastuzumab in patients with human epidermal...
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Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology
BackgroundA biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties...
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Application of NMR and Chemometric Analyses to Better Understand the Quality Attributes in pH and Thermally Degraded Monoclonal Antibodies
PurposeNuclear magnetic resonance (NMR) spectroscopy provides the sensitivity and specificity to probe the higher order structure (HOS) of monoclonal...
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Evaluation of homodimer 99mTc-HYNIC-E(SSSLTVPWY)2 peptide on HER2-over expressed breast cancer cells
The evidence resulting from a previous preclinical study of dimer LTVPWY peptide ( 99m Tc-DLY) has proved the capability of the tracer to recognize...
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Artificial Intelligence Based Framework to Quantify the Cardiomyocyte Structural Integrity in Heart Slices
PurposeDrug induced cardiac toxicity is a disruption of the functionality of cardiomyocytes which is highly correlated to the organization of the...
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Regulatory Considerations of Biosimilars in Cancer
In the fast-evolving field of cancer treatment, the introduction of biosimilars has brought about significant changes in the available therapeutic...
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Trastuzumab-functionalized bionic pyrotinib liposomes for targeted therapy of HER2-positive breast cancer
In this study, we prepared a bionic nanosystem of trastuzumab-functionalized SK-BR-3 cell membrane hybrid liposome-coated pyrotinib (Ptb-M-Lip-Her)...
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Purification of protein therapeutics via high-affinity supramolecular host–guest interactions
Efficient purification is crucial to providing large quantities of recombinant therapeutic proteins, such as monoclonal antibodies and cytokines....
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Companion Diagnostics and Clinical Biomarkers for Immunotherapy
The advancement of understanding the complexity of disease biology unraveled many targets, and accordingly, their ligands are investigated. However,...
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Promoting reactive oxygen species accumulation to overcome tyrosine kinase inhibitor resistance in cancer
BackgroundIn tumor treatment, protein tyrosine kinase inhibitors (TKIs) have been extensively utilized. However, the efficacy of TKI is significantly...
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Precision Medicine: Translation of Individualistic Treatment in Oncology
Cancer is a fatal illness that kills millions of people each year. Considering the heterogeneity of the disease, conventional therapies, like...
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Biosimilar in Cervical Cancer
Cervical Cancer is a serious health concern possessing a serious health problem in women. This chapter provides a comprehensive overview of the role...
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Genetic mutations in HER2-positive breast cancer: possible association with response to trastuzumab therapy
BackgroundHER2-positive breast cancer occurs in 15–20% of breast cancer patients and is characterized by poor prognosis. Trastuzumab is considered...
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Mechanism of Biosimilars for the Treatment of Cancer
Biosimilars are biological medications that closely resemble FDA-approved biological medications in terms of structure as well as functions and are...
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Monoclonal Antibodies in Nanosystems as a Strategy for Cancer Treatment
Monoclonal antibodies (mAbs) are valuable therapeutic tools for targeted therapies to attack tumor cells but preserve healthy tissues, therefore...
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Biosimilars in Gastric Cancer
Gastric cancer, often known as GC, continues to be one of the most common forms of cancer in the world. Its toll in 2020 exceeded one million new...
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Drug Product Design and Delivery of Biologics
This chapter is new to this edition. There has been a notable increase in biologic therapies in recent years. Compared to small molecules, biologics...