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1. Biosimilars and immunogenicity: a matter of concern? NSTL国家科技图书文献中心

Jarab, Anan S. |  Abu Heshmeh, Shrouq ...... -  《Expert opinion on drug safety》 - 2025,24(5) - 519~527 - 共9页

摘要: immunogenicity of biosimilars and discusses the regulatory |  immunogenicity on therapeutic efficacy and patient |  capture long-term immunogenicity data effectively. It | IntroductionBiosimilars have transformed |  treatment modalities across various medical fields such as
关键词: Biosimilars |  immunogenicity |  safety issues |  regulatory issues |  drug safety

2. Statistical Tutorial for Cut‐Point Determination in Immunogenicity Studies NSTL国家科技图书文献中心

Yulia Mordashova |  Xin Huang -  《Pharmaceutical statistics.》 - 2025,24(3) - e70016~e70016 - 共20页

摘要: of Immunogenicity and the ability to follow |  areas. In order to assess the immunogenicity of |  immunogenicity topics (immunoassays) cover the development and |  more robust immunogenicity assessments in clinical | ABSTRACT Administration of therapeutic protein
关键词: ADA assay cut‐point estimation |  ADA assay validation |  immunogenicity

3. The changes necessary in the assessment of immunogenicity for the development of Biosimilars NSTL国家科技图书文献中心

Poetzl, Johann -  《Bioanalysis》 - 2025,17(5/6) - 355~358 - 共4页

摘要:Immunogenicity knowledge and the analytical |  Reference. Within Immunogenicity Risk Assessment for |  Biosimilars, in silico and in vitro immunogenicity |  Biosimilar development. An ISI including an Immunogenicity |  immunogenicity in conjunction with analytical and clinical data
关键词: Biosimilars |  Immunogenicity Risk Assessment |  in silico and in vitro immunogenicity assessment |  integrated summary of immunogenicity |  signal-to-noise ratio |  singlicate sample analysis

4. A Meta-Analysis of the Safety and Immunogenicity of Pharmacokinetic Similarity Studies and Comparative Clinical Studies NSTL国家科技图书文献中心

Ji, Ping |  Schrieber, Sarah J.... -  《Journal of clinical pharmacology.》 - 2025,65(4) - 499~507 - 共9页

摘要: studies assess safety and immunogenicity, it is |  of the safety and immunogenicity data from |  valuable information for comparing the immunogenicity and | A biosimilar clinical development program |  generally includes a pharmacokinetic similarity study and
关键词: biosimilarity |  comparative clinical study |  immunogenicity |  pharmacokinetic similarity study |  safety

5. Enhanced immunogenicity of a BoHV-1 gG-/tk- vaccine NSTL国家科技图书文献中心

Zhang, Sen |  Liu, Guoxing... -  《Vaccine》 - 2025,47 - Article 126704~Article 126704 - 共8页

摘要: and superior immunogenicity compared to existing | Bovine herpesvirus type 1 (BoHV-1) is a |  widespread respiratory infection that significantly impacts |  cattle health worldwide. To address this issue in China | , we previously developed a novel double gene-deleted
关键词: BoHV-1 |  Gene-deleted vaccine |  Inactivated BoHV-1 vaccine |  Immunogenicity

6. Exploring the role of cationic lipids in modulating immunogenicity and vaccine efficacy of mRNA-LNP NSTL国家科技图书文献中心

Zhou, Yan |  Shan, Xiangfei... -  《Particuology》 - 2025,97 - 共11页

摘要: excessive immunogenicity, have demonstrated potential in |  enhance immunogenicity without requiring new lipid |  immunogenicity, expanding the potential applications of mRNA | The mRNA vaccines have become a transformative |  platform in medicine, with their success during the COVID
关键词: Lipid nanoparticle |  mRNA vaccine |  Immunogenicity |  Cationic lipids |  Immune response

7. The Immunogenicity of Coxsackievirus A6 (D3a Sub‐Genotype) Virus‐Like Particle and mRNA Vaccines NSTL国家科技图书文献中心

Huanhuan Lu |  Jinbo Xiao... -  《Journal of Medical Virology》 - 2025,97(2) - e70201~e70201 - 共15页

摘要: immunogenicity and protective effects of the VLP of CVA6 |  experiments. The immunogenicity and protective effects of |  worldwide and the first comparison of the immunogenicity | ABSTRACT In recent years, coxsackievirus A6 |  (CVA6) has surpassed enterovirus A71 to become the
关键词: coxsackievirus A6 |  immunogenicity |  mRNA vaccine |  protective effects |  virus‐like particle

8. Immunogenicity and safety of live attenuated influenza vaccine in children aged 3-17 years in China NSTL国家科技图书文献中心

Ai, Lizhe |  Gao, Zhao... -  《Vaccine》 - 2025,46 - Article 126653~Article 126653 - 共9页

摘要:. However, LAIV immunogenicity in children aged 3-17 years |  the immunogenicity and safety of the LAIV under a |  evaluate immunogenicity and safety, respectively. (3 | (1) Background: The administration of a live |  attenuated influenza vaccine (LAIV) has emerged as a viable
关键词: Live attenuated influenza vaccine (LAIV) |  Immunogenicity |  Safety |  Children

9. The role of immunogenicity in optimizing biological therapies for inflammatory bowel disease NSTL国家科技图书文献中心

Sharma, Konika |  da Silva, Bruno Cesa...... -  《Expert review of gastroenterology & hepatology》 - 2025,19(3) - 243~258 - 共16页

摘要: lower susceptibility to immunogenicity, potentially |  examines immunogenicity associated with different classes |  trials focusing on strategies to reduce immunogenicity |  demonstrate lower immunogenicity compared to anti-TNF agents |  pathways to reduce immunogenicity and enhance treatment
关键词: Immunogenicity |  anti-drug antibodies |  inflammatory bowel disease |  biologics |  therapeutic drug monitoring

10. Compromising the immunogenicity of diphtheria toxin-based immunotoxins through epitope engineering: An in silico approach NSTL国家科技图书文献中心

Golichenari, Behrouz |  Heiat, Mohammad... -  《Journal of Pharmacological and Toxicological Methods》 - 2025,131 - Article 107571~Article 107571 - 共13页

摘要: immunogenicity were identified through multiple platforms. By |  for DT, thereby reducing immunogenicity. Finally, a | Immunotoxins are genetically engineered |  recombinant proteins consisting of a targeting moiety, such |  as an antibody, and a cytotoxic toxin moiety of
关键词: Diphtheria toxin |  Immunotoxin |  In silico |  Denileukin Diftitox |  Epitope |  Immunogenicity
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