Allergo Journal最新文献_第8页

Requirements for regulatory acceptance of biomarkers 生物标记物监管接受要求

IF 1.1

Allergo Journal Pub Date : 2024-12-12 DOI: 10.1007/s15007-024-6397-8

Hilke Zander, Jörg Engelbergs

{"title":"Requirements for regulatory acceptance of biomarkers","authors":"Hilke Zander, Jörg Engelbergs","doi":"10.1007/s15007-024-6397-8","DOIUrl":"10.1007/s15007-024-6397-8","url":null,"abstract":"<div>Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit-risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVD) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific-regulatory considerations in this complex regulatory field.Cite this as Zander H, Engelbergs J. Requirements for regulatory acceptance of biomarkers. Allergo J Int 2024;33:309-12https://doi.org/10.1007/s40629-024-00312-w</div>","PeriodicalId":7418,"journal":{"name":"Allergo Journal","volume":"33 8","pages":"54 - 57"},"PeriodicalIF":1.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142810975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Reform oder Reförmchen? 改革还是改革？

IF 1.1

Allergo Journal Pub Date : 2024-12-12 DOI: 10.1007/s15007-024-6420-0

Thilo Jakob, Ludger Klimek, Wolfram Hötzenecker

引用次数: 0

Kann minimal verarbeitete Milch Allergien vorbeugen? 最低限度的加工牛奶能预防过敏吗？

IF 1.1

Allergo Journal Pub Date : 2024-12-12 DOI: 10.1007/s15007-024-6419-6

Sabrina Kempe

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Änderung des Einheitlichen Bewertungsmaßstabs ab Januar 2025 从2025年1月起修订单一评估量表

IF 1.1

Allergo Journal Pub Date : 2024-12-12 DOI: 10.1007/s15007-024-6404-0

Redaktion Facharztmagazine

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The role of IgG1 and IgG4 as dominant IgE-blocking antibodies during allergen immunotherapy IgG1和IgG4在过敏原免疫治疗中作为优势ige阻断抗体的作用

IF 1.1

Allergo Journal Pub Date : 2024-12-12 DOI: 10.1007/s15007-024-6398-7

Barbara Bohle

{"title":"The role of IgG1 and IgG4 as dominant IgE-blocking antibodies during allergen immunotherapy","authors":"Barbara Bohle","doi":"10.1007/s15007-024-6398-7","DOIUrl":"10.1007/s15007-024-6398-7","url":null,"abstract":"Allergen immunotherapy (AIT) is the only treatment that modifies the allergic response to allergens. One immune mechanism associated with a reduction in clinical symptoms is the induction of immunoglobulin E(IgE)-blocking antibodies. In particular, AIT-induced allergen-specific IgG4 antibodies were regarded a candidate biomarker for clinical efficacy. With the knowledge that not all AIT-induced allergen-specific IgG antibodies bear blocking bioactivity, different in vitro assays became popular to assess the blocking capacity of sera collected during and after AIT. Their measuring principles vary in the detection of the prevention of IgE-binding to allergen or of allergen interactions with IgE bound to high-affinity Fc epsilon receptors on the surface of effector cells. More recently, the contribution to IgE-blocking of other isotypes that arise in the course of AIT, e. g., IgG1 and IgA, was confirmed. The results indicated that different isotypes of allergen-specific antibodies serve as dominant IgE-blocking factors in the course of AIT.Cite this as Bohle B. The role of IgG1 and IgG4 as dominant IgE-blocking antibodies during allergen immunotherapy. Allergo J Int 2024;33: 282-8https://doi.org/10.1007/s40629-024-00309-5","PeriodicalId":7418,"journal":{"name":"Allergo Journal","volume":"33 8","pages":"26 - 33"},"PeriodicalIF":1.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142810901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

OIT bei Erdnussallergie: Desensibilisierung allein reicht nicht aus 国际劳工组织对花生过敏的反应：脱敏是不够的

IF 1.1

Allergo Journal Pub Date : 2024-12-12 DOI: 10.1007/s15007-024-6414-y

Sabrina Kempe

引用次数: 0

Buchtipp: „Allergie kurz und knapp“ “讣闻：简短而简短”。

IF 1.1

Allergo Journal Pub Date : 2024-12-12 DOI: 10.1007/s15007-024-6407-x

Michael Kohlhoff

引用次数: 0

Wichtige Fragen der modernen Allergologie 现代过敏症的关键问题