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
Result harmonization in medical laboratories: accomplishments and challenges

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EULAR recommendations for the management of rheumatoid arthritis with synthetic and biologic disease-modifying antirheumatic drugs: 2025 update

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Evaluating Dextrose-Derived Interference in Low-Concentration Monoclonal Antibody Quantification for Clinical In-Use Studies

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The European Medicines Agency (EMA)

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

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Real-world effectiveness of b/tsDMARD switching in low-inflammatory difficult-to-treat rheumatoid arthritis: insights from the FIRST registry

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2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A – Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))

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A Multitarget Screening Method for the Detection of Small Peptides in Dried Blood Spots for Doping Control Analysis

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Fresh from the biotech pipeline: FDA turmoil overshadows 2025 approvals

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CD19 CAR T-Cell Therapy for Autoimmune Hemolytic Anemia

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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 1708 FWCI226.2762

Artificial Intelligence in Pharmaceutical Technology and Drug Delivery Design

review Full Text OpenAlex 883 FWCI170.2963

The past, present, and future of antibiotics

review Full Text OpenAlex 586 FWCI44.9153

Biopharmaceutical benchmarks 2022

article Full Text OpenAlex 473 FWCI35.7933

Optimization of the Hemolysis Assay for the Assessment of Cytotoxicity

article Full Text OpenAlex 386 FWCI66.8522

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

review Full Text OpenAlex 330 FWCI112.7426

The Bioavailability of Drugs—The Current State of Knowledge

article Full Text OpenAlex 305 FWCI58.9074

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

review Full Text OpenAlex 300 FWCI67.0721

Validation of biomarkers of aging

review Full Text OpenAlex 289 FWCI313.3267

Antibodies to watch in 2023

article Full Text OpenAlex 266 FWCI37.5497