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
A compartmentalized microfluidic platform to investigate immune cells cross-talk in rheumatoid arthritis

article Full Text OpenAlex

“Enhancing Pharmaceutical Accessibility: Evaluating the Impact of Competitive Generic Therapy Exclusivity on Rapid Access of Generics into the U.S. Market (2019–2024)”

article Full Text OpenAlex

Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance

article Full Text OpenAlex

Antidrug antibodies to adalimumab do not associate with immunologically related adverse events

article Full Text OpenAlex

Clinical and Operational Applications of Artificial Intelligence and Machine Learning in Pharmacy: A Narrative Review of Real-World Applications

review Full Text OpenAlex

A real-world pharmacovigilance study of omalizumab using disproportionality analysis in the FDA adverse drug events reporting system database

article Full Text OpenAlex

Generation of a T cell receptor, cytokine and cell repertoire synovial fluid atlas to define commonalities and dissimilarities between arthritic diseases through systems immunology approaches

preprint Full Text OpenAlex

Effectiveness of Adalimumab Biosimilars and Originator for Psoriasis

letter Full Text OpenAlex

The Evolving Landscape of Biologics—Biosimilars, Biobetters, and Bioparallels

article Full Text OpenAlex

Developing a Set of AI Ethics Principles to Shape Ethical Behavior in Drug Development

letter Full Text OpenAlex

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 1472 FWCI330.20683086

Artificial Intelligence in Pharmaceutical Technology and Drug Delivery Design

review Full Text OpenAlex 721 FWCI222.7610279

The past, present, and future of antibiotics

review Full Text OpenAlex 507 FWCI60.34572016

FDA approves 100th monoclonal antibody product

review Full Text OpenAlex 480 FWCI65.65686567

Biopharmaceutical benchmarks 2022

article Full Text OpenAlex 410 FWCI48.85845572

Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future

review Full Text OpenAlex 327 FWCI22.2689536

Targeted Drug Delivery — From Magic Bullet to Nanomedicine: Principles, Challenges, and Future Perspectives

review Full Text OpenAlex 316 FWCI35.88170208

Optimization of the Hemolysis Assay for the Assessment of Cytotoxicity

article Full Text OpenAlex 306 FWCI91.03428523

How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment

review Full Text OpenAlex 303 FWCI46.09315519

Optimization of therapeutic antibodies by predicting antigen specificity from antibody sequence via deep learning

article Full Text OpenAlex 288 FWCI33.87108946