专题：Biosimilars and Bioanalytical Methods

This cluster of papers focuses on the immunogenicity of biosimilar therapeutics, including the validation of bioanalytical methods for assessing immunogenicity, the impact of manufacturing changes on immunogenicity, and the clinical outcomes and safety of switching from reference biologics to biosimilars. The use of dried blood spots for bioanalysis and the regulatory considerations for biosimilars are also prominent topics within this cluster.
最新文献
Drivers and ethical impacts of insufficient validation of antibodies in research

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Analysis of non-prospective trial registration in clinical trials submitted to The BMJ : observational study

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External Quality Assurance Scheme in Clinical Biochemistry: Experience of CMC EQAS on the Continuous Improvement in Indian Medical Laboratories

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Evaluation of hematological parameters as biomarkers of disease activity in drug-naïve patients with rheumatoid arthritis: a retrospective analysis

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High concentration subcutaneous biological drug products: challenges and advancements

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Clinical Outcomes from the Pooled Safety Analysis of CD19 Nex-T™ (BMS-986353), a Chimeric Antigen Receptor (CAR) T cell Therapy Manufactured Using a Next-Generation Process, in Severe Refractory Autoimmune Diseases: Results from Phase 1 Breakfree Studies

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A descriptive comparison of phase 3 results and head-to-head trials in inflammatory bowel diseases

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A Rising Cluster of Erythropoietin‐Associated Pure Red Cell Aplasia and Subsequent Response to Roxadustat: A Case Series

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Successful Treatment of Oxaliplatin‐Induced Immune Thrombocytopenia in a Schizophrenic Patient With Contraindication to Steroids Using Cyclosporine Plus Eltrombopag: A Case Report

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Advancing Quantitative ADA Detection Through Model Informed Assay Development (MIAD)

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近5年高被引文献
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update

article Full Text OpenAlex 1608 FWCI232.074

Artificial Intelligence in Pharmaceutical Technology and Drug Delivery Design

review Full Text OpenAlex 840 FWCI169.2697

The past, present, and future of antibiotics

review Full Text OpenAlex 559 FWCI44.8077

Biopharmaceutical benchmarks 2022

article Full Text OpenAlex 455 FWCI35.8631

Optimization of the Hemolysis Assay for the Assessment of Cytotoxicity

article Full Text OpenAlex 361 FWCI64.3588

The Bioavailability of Drugs—The Current State of Knowledge

article Full Text OpenAlex 283 FWCI57.0278

Artificial Intelligence (AI) Applications in Drug Discovery and Drug Delivery: Revolutionizing Personalized Medicine

review Full Text OpenAlex 280 FWCI104.4371

Validation of biomarkers of aging

review Full Text OpenAlex 263 FWCI306.847

Antibodies to watch in 2023

article Full Text OpenAlex 263 FWCI36.7415

Advancing Precision Medicine: A Review of Innovative In Silico Approaches for Drug Development, Clinical Pharmacology and Personalized Healthcare

review Full Text OpenAlex 260 FWCI64.8367